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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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This trial seeks to assess if potassium nitrate (KNO3) therapy improves exercise capacity and oxygen uptake in heart failure patients with preserved ejection fraction (HFpEF).
Approximately 50% of heart failure patients exhibit preserved left ventricular (LV) ejection fraction (EF), and therefore have HF with preserved EF (HFpEF). There are currently no proven effective pharmacologic interventions. Exercise intolerance with reduced aerobic capacity is the hallmark of HFpEF and greatly impairs quality of life (QOL). During exercise, blood vessels within active muscle vasodilator, increasing perfusion to the muscle bed. Nitric oxide is a chief mediator of this process. Inorganic nitrate can ultimately be converted to nitric oxide. This conversion occurs preferentially at the site of exercising muscle, allowing for vasodilation to occur, hence increasing blood flow to the working muscle. Preliminary data suggest that inorganic nitrate improves exercise tolerance in HFpEF. The investigator will aim to test this hypothesis in a larger group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potassium Nitrate (KNO3) | Experimental | Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks. |
|
| Potassium Chloride (KCl) | Placebo Comparator | Potassium Chloride (KCl) is the placebo (control drug) in this trial. Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Nitrate (KNO3) | Drug | The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Peak Oxygen Consumption (Vo2) Between KNO3 and KCl Phases | Subjects will perform a maximal-effort peak oxygen consumption test using a supine bicycle exercise test with expired gas analysis. | 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
| Change in Total Work Performed During a Maximal-effort Exercise Test From Phase 1 to Phase 2 | Subjects will perform a maximal-effort supine bicycle exercise test. | 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Potassium Nitrate (KNO3) on Quality of Life (QOL) | QOL will be assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ). The overall summary score from the KCCQ ranges from 0-100, where higher scores indicate a better quality of life. | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
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Inclusion Criteria:
Adults aged 18-90 years of age
A diagnosis of heart failure with NYHA Class II-III symptoms
LV ejection fraction >50% during baseline echocardiography
Stable medical therapy: no addition/removal/changes in antihypertensive medications, or beta-blockers in the preceding 30 days
Elevated filling pressures as evidenced by at least 1 of the following:
Mitral E/e' ratio > 8 (either lateral or septal), with low e' velocity (septal e'<7 cm/sec or lateral e'< 10 cm/sec), in addition to one of the following:
i Enlarged left atrium (LA volume index >34 ml/m2) ii Chronic loop diuretic use for control of symptoms iii Elevated natriuretic peptides (BNP levels >100 ng/L or NT-proBNP levels >300 ng/L)
Mitral E/e' ratio > 14 (either lateral or septal)
Elevated invasively-determined filling pressures previously (resting LVEDP>16 mmHg or mean pulmonary capillary wedge pressure [PCWP] > 12 mmHg; or PCWP/LVEDP≥25 mmHg with exercise)
Acute heart failure decompensation requiring IV diuretics
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julio A Chirinos, MD, PhD | University of Pennsylvania | Study Chair |
| Payman Zamani, MD | University of Pennsylvania | Principal Investigator |
| Sanjiv Shah, MD | Northwestern University | Principal Investigator |
| Sujith Kuruvilla, MD | Corporal Michael J Crescenz Veterans Affairs Medical Center (VA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medical Center | Evanston | Illinois | 60208 | United States | ||
| Corporal Michael J Crescenz Veterans Affairs Medical Center (VA) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39693096 | Derived | Zamani P, Shah SJ, Cohen JB, Zhao M, Yang W, Afable JL, Caturla M, Maynard H, Pourmussa B, Demastus C, Mohanty I, Miyake MM, Adusumalli S, Margulies KB, Prenner SB, Poole DC, Wilson N, Reddy R, Townsend RR, Ischiropoulos H, Cappola TP, Chirinos JA. Potassium Nitrate in Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA Cardiol. 2025 Mar 1;10(3):284-289. doi: 10.1001/jamacardio.2024.4417. |
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Following the endpoint assessment of the first phase, subjects will enter a 1-week washout period during which they will not receive any study medications.
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| ID | Title | Description |
|---|---|---|
| FG000 | Potassium Nitrate (KNO3), Then Potassium Chloride (KCl) | Potassium nitrate (KNO3) capsules, provided 6 millimoles of inorganic nitrate per capsule, and was taken three times daily for 6 weeks. After a one week washout period, participants crossed over to take Potassium Chloride. Potassium Chloride (KCl) capsules was administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks. Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2021 |
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| Potassium Chloride (KCl) | Drug | Potassium Chloride (KCl) is the matching placebo control drug in this trial. |
|
| Effect of KNO3 on the Percent Change of Systemic Vasodilatory Response to Exercise: The Change in Systemic Vascular Resistance Reserve During Exercise During a Maximal Effort Exercise Test | We measured the Systematic vasodilatory response at rest and peak maximal exercise using corresponding echo parameters and blood pressures for each visit. This measure depicts the change from rest and exercise. | 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
| Effect of Potassium Nitrate (KNO3) on Muscle Phosphocreatine (PCr) Recovery Kinetics Following a Standardized Plantar Flexor Exercise Protocol | Muscle PCr recovery kinetics were measured using MRI and a standardized plantar flexor exercise protocol with a high resolution spatial mapping of creatine in muscle to analyze creatine chemical exchange saturation transfer and quantify the recovery kinetics of creatine levels. Exercise induces increases in the rate of O2 consumption, which upon cessation of exercise, declines towards baseline in a mono-exponential fashion. This is characterized by a time constant (τ, tau) that corresponds to the time constant of PCr recovery kinetics. Muscle PCr is a marker of oxidative capacity. This outcome measure relates to the half-time derived from linear regression, where a lower value depicts a faster PCr recovery. | 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
| Effect of Potassium Nitrate (KNO3) on Left Ventricle (LV) Diastolic Function: E/e' Ratio | E/e' ratio is a standard echo parameter that was measured at rest during each visit and calculated using the mitral E, septal e', and lateral e'. This index is parameter for noninvasive left ventricular diastolic function assessment, where an E/e' ratio < 8 is considered to be normal, and a ratio > 15 is considered to reflect an increase in the LV filling pressure. | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
| Effect of Potassium Nitrate (KNO3) on Left Ventricle (LV) Diastolic Function: Left Atrial Volume Index | Left atrial volume index is a standard echo parameter that was measured at rest during each visit and calculated the body surface area (Dubois and Dubois equation) and left atrial volume from both the two chamber and four chamber views. | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
| Effect of Potassium Nitrate (KNO3) on Myocardial Systolic Strain: Peak Global Systolic Myocardial Longitudinal Strain | Peak global systolic myocardial longitudinal strain was evaluated with resting echocardiograms at each visit. Strain was analyzed at the four chamber, two chamber, and three chamber views of the left ventricle and averaged. | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
| Effect of Potassium Nitrate (KNO3) on Late Systolic Wall Stress as Assessed by the Arts Formula Using Echocardiographic and Tonometry Recordings | Late systolic wall stress is assessed via comprehensive aortic pressure-flow relations, using arterial tonometry and Doppler echocardiography. Myocardial wall stress was calculated with the following formula =: Stress = P / [1/3 In (1 + VW/VLV)], where ln is the natural logarithm, P is aortic pressure obtained with arterial tonometry, VW is the volume of the LV wall obtained with echocardiography and VLV is the cavity volume obtained with echocardiography | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
| Effect of Potassium Nitrate (KNO3) on Arterial Wave Reflections as Assessed by Wave Separation Analysis Using Tonometry and Doppler Flow Data | Arterial Wave reflections were assessed via wave separation analysis, using arterial tonometry and Doppler echocardiography. The pulse wave generated by the left ventricle travels forward in arteries and is partially reflected at sites of impedance mismatch (i.e., bifurcations, points of change in arterial size or wall stiffness, predominantly in middle-sized conduit arteries). Wave reflections travel back to the heart, merging into a discrete reflected wave and arrive while the LV is still ejecting blood in mid-to-late systole. Wave reflections increase the late systolic workload of the LV and profoundly impact the LV loading sequence (late relative to early systolic load). | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
| Effect of Potassium Nitrate (KNO3) on Augmentation Index | Aortic augmentation index was assessed via comprehensive aortic pressure-flow relations, using arterial tonometry and Doppler echocardiography. It is an indirect measure of arterial stiffness, where a higher value would indicate greater arterial stiffness risk. | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
| Effect of Potassium Nitrate (KNO3) on Muscle Blood Flow During Exercise: Muscle Blood Flow During Exercise, Measured With Arterial MRI Spin Labeling During a Standardized Plantar Flexion Exercise Test | MRI studies will be performed at rest and immediately after a standardized plantar flexion exercise. Arterial spin labeling using the flow-sensitive alternating inversion recovery (FAIR) technique will be used to image muscle perfusion with high temporal resolution. | 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
| Effect of Potassium Nitrate (KNO3) on Myocardial Systolic Strain: Peak Global Systolic Myocardial Circumferential Strain | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| FG001 | Potassium Chloride (KCl) Then Potassium Nitrate (KNO3) | Potassium Chloride (KCl) capsules was administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks. Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial. Potassium Nitrate (KNO3) capsules, provided 6 millimoles of inorganic nitrate per capsule, and was taken three times daily for 6 weeks. After a one week washout period, participants crossed over to take Potassium Nitrate. |
| COMPLETED |
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| NOT COMPLETED |
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| Phase 2 (Crossover) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Potassium Nitrate (KNO3) Then Potassium Chloride (KCl) | Participants were randomized and first received potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks. Potassium nitrate is the active drug in this trial. After a washout period of 1 week, participant crossed over to receive potassium chloride (KCl), the matching placebo (control drug) in this trial. Potassium Chloride (KCl) capsules were administered at a dose of 6 millimoles (1 capsule) three times daily for 6 week. |
| BG001 | Experimental: Potassium Chloride (KCl) Then Potassium Nitrate (KNO3) | Participants were randomized and first received potassium chloride (KCl), the matching placebo (control drug) in this trial. Potassium Chloride (KCl) capsules were administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks. After a washout period of 1 week, participants cross over to receive potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| Current Smoker | Medical history was obtained via medical chart review and participant self-reporting. Smoking status was obtained as part of their social history. | Count of Participants | Participants |
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| Former smoker | Medical history was obtained via medical chart review and participant self-reporting. Smoking status was obtained as part of their social history. | Count of Participants | Participants |
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| Prior Acute Coronary Syndrome or Myocardial infarction | For all participants, past medical history was obtained using chart review and participant self-reports. | Count of Participants | Participants |
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| Prior Angina | For all participants, past medical history was obtained using chart review and participant self-reports. | Count of Participants | Participants |
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| Prior Arrythmia | For all participants, past medical history was obtained using chart review and participant self-reports. Any arrhythmia would be included in this category. | Count of Participants | Participants |
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| Prior significant valvular disease or valve surgery in the past | For all participants, past medical history was obtained using chart review and participant self-reports. | Count of Participants | Participants |
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| Hypertension | For all participants, past medical history was obtained using chart review and participant self-reports. | Count of Participants | Participants |
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| High Cholesterol | For all participants, past medical history was obtained using chart review and participant self-reports. | Count of Participants | Participants |
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| Peripheral vascular disease | For all participants, past medical history was obtained using chart review and participant self-reports. Peripheral vascular disease included carotid, aortic, or femoral stenosis or history of claudications. | Count of Participants | Participants |
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| Diabetes | For all participants, past medical history was obtained using chart review and participant self-reports. | Count of Participants | Participants |
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| Prior CVA/TIA | For all participants, past medical history was obtained using chart review and participant self-reports. | Count of Participants | Participants |
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| Prior Pulmonary embolism/DVT | For all participants, past medical history was obtained using chart review and participant self-reports. | Count of Participants | Participants |
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| Obstructive sleep apnea (OSA) | For all participants, past medical history was obtained using chart review and participant self-reports. | Count of Participants | Participants |
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| COPD/Asthma | For all participants, past medical history was obtained using chart review and participant self-reports. | Count of Participants | Participants |
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| Prior CABG | For all participants, past medical history was obtained using chart review and participant self-reports. | Count of Participants | Participants |
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| Osteoarthritis | For all participants, past medical history was obtained using chart review and participant self-reports. | Count of Participants | Participants |
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| NYHA Class | The NYHA (New York Heart Association) classification system was used to classify participant symptoms during the baseline visit by study team. The following symptoms were assessed: orthopnea, paroxysmal nocturnal dyspnea, lower extremity edema, dyspnea upon exertion, and walking distance before stopping. With these symptoms, participants were then classified into the following NYHA classes: NYHA Class I = no symptoms NYHA Class II = symptoms with significant exertion NYHA Class III = symptoms with mild exertion NYHA Class IV = symptoms occur at rest | Count of Participants | Participants |
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| Systolic Blood Pressure | The baseline physical exam measured all vital signs. | Mean | Standard Deviation | mmHg |
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| Diastolic Pressure | The baseline physical exam measured all vital signs. | Mean | Standard Deviation | mmHg |
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| Blood Oxygen Saturation | The baseline physical exam measured all vital signs. | Mean | Standard Deviation | percent (%) oxygen saturation |
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| 6 Minute Walk Test: Total Meters Walk | At the baseline visit, 6 minute walk tests were performed. | Mean | Standard Deviation | meters |
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| Kansas City Cardiomyopathy Questionnaire (KCCQ) Results | KCCQ surveys were provided to participants at baseline, phase 1 visit, and phase 2 visit and scored according to KCCQ guidelines. The surveys were then scored using KCCQ guidelines, in which KCCQ scores range from 0-100, where a lower score indicates more severe symptoms/limitations and 100 indicates no symptoms. | Mean | Standard Deviation | scores on a scale of 0-100 |
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| Current Medications | Current medications were obtained via medical chart review and participant self-reporting. | Count of Participants | Participants |
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| eGFR | eGFR was calculated with the 2009 CKD-EPI creatinine equation by study team. The creatinine lab results were processed during study visits. | Mean | Standard Deviation | mL/min/1.73m^2 |
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| Methemeglobin | During the baseline visit, participants consented to a co-oximetry blood panel, and the processing lab provided the resulting levels. | Mean | Standard Deviation | Percent in blood |
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| Oxyhemoglobin | During the baseline visit, participants consented to a co-oximetry blood panel, and the processing lab provided the resulting levels. | Mean | Standard Deviation | Percent in blood |
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| Carboxyhemoglobin | During the baseline visit, participants consented to a co-oximetry blood panel, and the processing lab provided the resulting levels. | Mean | Standard Deviation | Percent in blood |
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| O2 Count | During the baseline visit, participants consented to a co-oximetry blood panel, and the processing lab provided the resulting levels. | Mean | Standard Deviation | mL/dL |
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| Hemoglobin | During the baseline visit, participants consented to a co-oximetry blood panel, and the processing lab provided the resulting levels. | Mean | Standard Deviation | g/dL |
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| NT Pro-BNP | A sample was collected as part of visit labs and processed by our clinical laboratory for NT ProBNP | Mean | Standard Deviation | pg/mL |
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| Ejection Fraction | A baseline echocardiogram was performed and quantified. | Mean | Standard Deviation | Percent total blood |
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| Left Atrial Volume Index | A baseline echocardiogram was performed and quantified. | Mean | Standard Deviation | mL/m^2 |
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| Septal E/e' Ratio | A baseline echocardiogram was performed and quantified. | Mean | Standard Deviation | Ratio |
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| Lateral E/e' Ratio | A baseline echocardiogram was performed and quantified. | Mean | Standard Deviation | Ratio |
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| Septal Lateral Mean E/e' Ratio | A baseline echocardiogram was performed and quantified. | Mean | Standard Deviation | Ratio |
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| White Blood Cells | A CBC panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | THO/uL |
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| Red Blood Cells | A CBC panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | MIL/uL |
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| Hemoglobin | A CBC panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | g/dL |
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| Hematocrit | A CBC panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | Percent of blood |
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| RDW (red blood cell distribution width) | A CBC panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | Percent red blood cells |
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| MCH (mean corpuscular hemoglobin) | A CBC panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | pg |
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| MCHC (mean corpuscular hemoglobin concentration) | A CBC panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | g/dL |
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| MCV (mean corpuscular volume) | A CBC panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | fL |
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| Platelets | Measure Description: A CBC panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | THO/uL |
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| Glucose | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | mg/dL |
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| Urea Nitrogen | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | mg/dL |
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| Creatinine | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | mg/dL |
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| Sodium | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | mmol/L |
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| Potassium | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | mmol/L |
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| Chloride | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | mmol/L |
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| Carbon dioxide | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | mmol/L |
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| Anion gap | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | mmol/L |
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| Calcium | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | mg/dL |
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| Protein, total | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | g/dL |
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| Albumin, total | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | g/dL |
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| Bilirubin, total | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | mg/dL |
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| Alkaline phophatase | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | U/L |
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| AST (aspartate transferase) | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | U/L |
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| ALT (alanine transaminase) | A CMP panel was collected as part of visit labs and processed by our clinical laboratory. | Mean | Standard Deviation | U/L |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Peak Oxygen Consumption (Vo2) Between KNO3 and KCl Phases | Subjects will perform a maximal-effort peak oxygen consumption test using a supine bicycle exercise test with expired gas analysis. | As this is a crossover trial, participants received both KNO3 and KCl in different phase, and the sequence of which was dependent on a double blinded randomization. Only participants with outcome data were analyzed. The mean, SD, and t-tests were calculated based on the number of completed cases with successful crossover (N=60), but the mixed model included phase 1 data as well (N=74). | Posted | Mean | Standard Deviation | L/min/kg | 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
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| Primary | Change in Total Work Performed During a Maximal-effort Exercise Test From Phase 1 to Phase 2 | Subjects will perform a maximal-effort supine bicycle exercise test. | Total work was calculated at each phase of the crossover trial. However, the analysis for the t-tests including the reported mean and standard deviation only includes cases in which Phase 1 and Phase 2 were completed. | Posted | Mean | Standard Deviation | KJ | 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
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| Secondary | Effect of Potassium Nitrate (KNO3) on Quality of Life (QOL) | QOL will be assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ). The overall summary score from the KCCQ ranges from 0-100, where higher scores indicate a better quality of life. | As this is a crossover trial, participants received both KNO3 and KCl in different phases, the sequence of which was dependent on a double blinded randomization. Only participants with KCCQ results were analyzed. The mean, SD, and t-tests were calculated based on the number of completed cases with successful crossover (N=66), but the mixed model included phase 1 data as well. Baseline scores for all participants were analyzed in the mixed model as a predictive value. | Posted | Mean | Standard Deviation | score on a scale | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
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| Secondary | Effect of KNO3 on the Percent Change of Systemic Vasodilatory Response to Exercise: The Change in Systemic Vascular Resistance Reserve During Exercise During a Maximal Effort Exercise Test | We measured the Systematic vasodilatory response at rest and peak maximal exercise using corresponding echo parameters and blood pressures for each visit. This measure depicts the change from rest and exercise. | Posted | Mean | Standard Deviation | % change | 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
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| Secondary | Effect of Potassium Nitrate (KNO3) on Muscle Phosphocreatine (PCr) Recovery Kinetics Following a Standardized Plantar Flexor Exercise Protocol | Muscle PCr recovery kinetics were measured using MRI and a standardized plantar flexor exercise protocol with a high resolution spatial mapping of creatine in muscle to analyze creatine chemical exchange saturation transfer and quantify the recovery kinetics of creatine levels. Exercise induces increases in the rate of O2 consumption, which upon cessation of exercise, declines towards baseline in a mono-exponential fashion. This is characterized by a time constant (τ, tau) that corresponds to the time constant of PCr recovery kinetics. Muscle PCr is a marker of oxidative capacity. This outcome measure relates to the half-time derived from linear regression, where a lower value depicts a faster PCr recovery. | MRI was not completed throughout the duration of the study and only completed at one site (University of Pennsylvania). | Posted | Mean | Standard Deviation | seconds | 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
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| Secondary | Effect of Potassium Nitrate (KNO3) on Left Ventricle (LV) Diastolic Function: E/e' Ratio | E/e' ratio is a standard echo parameter that was measured at rest during each visit and calculated using the mitral E, septal e', and lateral e'. This index is parameter for noninvasive left ventricular diastolic function assessment, where an E/e' ratio < 8 is considered to be normal, and a ratio > 15 is considered to reflect an increase in the LV filling pressure. | All participants were expected to undergo an echocardiogram at each visit (baseline, Phase 1, and Phase 2). | Posted | Mean | Standard Deviation | Ratio | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
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| Secondary | Effect of Potassium Nitrate (KNO3) on Left Ventricle (LV) Diastolic Function: Left Atrial Volume Index | Left atrial volume index is a standard echo parameter that was measured at rest during each visit and calculated the body surface area (Dubois and Dubois equation) and left atrial volume from both the two chamber and four chamber views. | Posted | Mean | Standard Deviation | mL/m2 | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
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| Secondary | Effect of Potassium Nitrate (KNO3) on Myocardial Systolic Strain: Peak Global Systolic Myocardial Longitudinal Strain | Peak global systolic myocardial longitudinal strain was evaluated with resting echocardiograms at each visit. Strain was analyzed at the four chamber, two chamber, and three chamber views of the left ventricle and averaged. | All participants underwent an echocardiogram at each visit; however, participants in which these echo measures could not be reliably quantified were excluded. | Posted | Mean | Standard Deviation | % (change in length) | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
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| Secondary | Effect of Potassium Nitrate (KNO3) on Late Systolic Wall Stress as Assessed by the Arts Formula Using Echocardiographic and Tonometry Recordings | Late systolic wall stress is assessed via comprehensive aortic pressure-flow relations, using arterial tonometry and Doppler echocardiography. Myocardial wall stress was calculated with the following formula =: Stress = P / [1/3 In (1 + VW/VLV)], where ln is the natural logarithm, P is aortic pressure obtained with arterial tonometry, VW is the volume of the LV wall obtained with echocardiography and VLV is the cavity volume obtained with echocardiography | Posted | Mean | Standard Deviation | dynes·cm-2·s | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
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| Secondary | Effect of Potassium Nitrate (KNO3) on Arterial Wave Reflections as Assessed by Wave Separation Analysis Using Tonometry and Doppler Flow Data | Arterial Wave reflections were assessed via wave separation analysis, using arterial tonometry and Doppler echocardiography. The pulse wave generated by the left ventricle travels forward in arteries and is partially reflected at sites of impedance mismatch (i.e., bifurcations, points of change in arterial size or wall stiffness, predominantly in middle-sized conduit arteries). Wave reflections travel back to the heart, merging into a discrete reflected wave and arrive while the LV is still ejecting blood in mid-to-late systole. Wave reflections increase the late systolic workload of the LV and profoundly impact the LV loading sequence (late relative to early systolic load). | Posted | Mean | Standard Deviation | unitless | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
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| Secondary | Effect of Potassium Nitrate (KNO3) on Augmentation Index | Aortic augmentation index was assessed via comprehensive aortic pressure-flow relations, using arterial tonometry and Doppler echocardiography. It is an indirect measure of arterial stiffness, where a higher value would indicate greater arterial stiffness risk. | Posted | Mean | Standard Deviation | Index | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
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| Secondary | Effect of Potassium Nitrate (KNO3) on Muscle Blood Flow During Exercise: Muscle Blood Flow During Exercise, Measured With Arterial MRI Spin Labeling During a Standardized Plantar Flexion Exercise Test | MRI studies will be performed at rest and immediately after a standardized plantar flexion exercise. Arterial spin labeling using the flow-sensitive alternating inversion recovery (FAIR) technique will be used to image muscle perfusion with high temporal resolution. | Analysis could not be performed as the MRI studies were not able to extract this measure. | Posted | 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
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| Secondary | Effect of Potassium Nitrate (KNO3) on Myocardial Systolic Strain: Peak Global Systolic Myocardial Circumferential Strain | Peak Global Systolic Myocardial Circumferential Strain was not analyzed in the echocardiogram as this measure was not quantified at all during the study; instead, other strain measurements were evaluated alternatively that are considered to be more reliable. | Posted | All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control) |
|
Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization.
Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Potassium Nitrate (KNO3) | Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks. Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed. | 0 | 77 | 1 | 77 | 43 | 77 |
| EG001 | Potassium Chloride (KCl) | Potassium Chloride (KCl) is the placebo (control drug) in this trial. Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks. Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial. | 0 | 74 | 1 | 74 | 45 | 74 |
| EG002 | Baseline Visit | At the baseline visit, patients were not on IP, but participants were monitored and consented in the study. All participants were at risk during their baseline visit, even the screen fails. Events include events that occurred in participants who were not randomized as well as those who were randomized. | 0 | 84 | 1 | 84 | 61 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abnormal sensation of swallowing | Gastrointestinal disorders | Systematic Assessment |
| ||
| aches in the joints | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| acute exacerbation of bronchiectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| belching | Gastrointestinal disorders | Systematic Assessment |
| ||
| bilateral knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| bloating | Gastrointestinal disorders | Systematic Assessment |
| ||
| blurred vision | Eye disorders | Systematic Assessment |
| ||
| bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| calves aching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| chest pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| creatinine increase | Renal and urinary disorders | Systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| dizziness | Nervous system disorders | Systematic Assessment |
| ||
| edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| fatigue | General disorders | Systematic Assessment |
| ||
| fever | Immune system disorders | Systematic Assessment |
| ||
| flu | Infections and infestations | Systematic Assessment |
| ||
| gassiness | Gastrointestinal disorders | Systematic Assessment |
| ||
| headache | General disorders | Systematic Assessment |
| ||
| hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| hypoglycemic episode | Endocrine disorders | Systematic Assessment |
| ||
| increased stomach acid | Gastrointestinal disorders | Systematic Assessment |
| ||
| insomnia | Nervous system disorders | Systematic Assessment |
| ||
| leg cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| lightheadedness | Nervous system disorders | Systematic Assessment |
| ||
| lower back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| hypoxemia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| nasal discharge | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| nervousness | Psychiatric disorders | Systematic Assessment |
| ||
| o2 desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| oral thrush | Infections and infestations | Systematic Assessment |
| ||
| palpitations | Cardiac disorders | Systematic Assessment |
| ||
| positive orthostat | General disorders | Systematic Assessment |
| ||
| rapid heart beat | Cardiac disorders | Systematic Assessment |
| ||
| restlessness | Nervous system disorders | Systematic Assessment |
| ||
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| shortness of breath during the peak exercise test | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| sinus infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| stomach ache | Gastrointestinal disorders | Systematic Assessment |
| ||
| swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| thigh cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| fatigue during the peak exercise test | General disorders | Systematic Assessment |
| ||
| other | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abnormal sensation of swallowing | Gastrointestinal disorders | Systematic Assessment |
| ||
| aches in the joints | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| acute exacerbation of bronchiectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| belching | Gastrointestinal disorders | Systematic Assessment |
| ||
| bilateral knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| bloating | Gastrointestinal disorders | Systematic Assessment |
| ||
| blurred vision | Eye disorders | Systematic Assessment |
| ||
| bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| calves aching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| chest pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| creatinine increase | Renal and urinary disorders | Systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| dizziness | Nervous system disorders | Systematic Assessment |
| ||
| edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| fatigue | General disorders | Systematic Assessment |
| ||
| fever | Immune system disorders | Systematic Assessment |
| ||
| flu | Infections and infestations | Systematic Assessment |
| ||
| gassiness | Gastrointestinal disorders | Systematic Assessment |
| ||
| headache | General disorders | Systematic Assessment |
| ||
| hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| hypoglycemic episode | Endocrine disorders | Systematic Assessment |
| ||
| increased stomach acid | Gastrointestinal disorders | Systematic Assessment |
| ||
| insomnia | Nervous system disorders | Systematic Assessment |
| ||
| leg cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| lightheadedness | Nervous system disorders | Systematic Assessment |
| ||
| lower back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| hypoxemia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| nasal discharge | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| nervousness | Psychiatric disorders | Systematic Assessment |
| ||
| o2 desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| oral thrush | Infections and infestations | Systematic Assessment |
| ||
| palpitations | Cardiac disorders | Systematic Assessment |
| ||
| positive orthostat | General disorders | Systematic Assessment |
| ||
| rapid heart beat | Cardiac disorders | Systematic Assessment |
| ||
| restlessness | Nervous system disorders | Systematic Assessment |
| ||
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| shortness of breath during the peak exercise test | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| sinus infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| stomach ache | Gastrointestinal disorders | Systematic Assessment |
| ||
| swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| thigh cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| fatigue during the peak exercise test | General disorders | Systematic Assessment |
| ||
| other | General disorders | Systematic Assessment |
|
Due to dispensing errors, nine participants didn't crossover. Overall study power was maintained. MRI completion varied across sites, leading to the discontinuation of this study component. MRI endpoints have a smaller N; interpret results cautiously. Myocardial circumferential strain wasn't quantified. Instead, longitudinal LV function, crucial for LV relaxation and filling, was quantified.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hannah Maynard | University of Pennsylvania | 215-662-7580 | hannah.maynard@pennmedicine.upenn.edu |
| Jul 20, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 7, 2022 | Jul 20, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C023844 | potassium nitrate |
| D017419 | Potassium, Dietary |
| ID | Term |
|---|---|
| D017680 | Potassium Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
| Male |
|
| White |
|
| No |
|
| No |
|
| CPAP Use |
|
| II |
|
| III |
|
| IV |
|
| Symptom Stability Score |
|
| Symptom Frequency Score |
|
| Sympton Burden Score |
|
| Total Symptom Score |
|
| Self-efficacy Score |
|
| Quality of Life Score |
|
| Social Limitation Summary Score |
|
| Overall Score |
|
| Clinical Summary Score |
|
| Angiotensin Receptor Blockers (ARB) |
|
| Calcium Channel Blockers (CCB) |
|
| Beta Blockers |
|
| Diuretics |
|
| Statins |
|
| Anti Arrythmia |
|
| Anti Coagulation |
|
| Anti Platelet |
|
| Insulin |
|
Only participants that successfully crossed over were included in the t-test (N=59).
| Superiority |
| The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect. | Mixed Models Analysis | 0.711 | Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05. | Slope | 0.10 | 2-Sided | 95 | -.043 | 0.62 | Superiority |
| Units |
|---|
| Counts |
|---|
| Participants |
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| OG002 | Baseline | Prior to randomization |
|
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|
| Counts |
|---|
| Participants |
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|
Potassium Chloride (KCl) is the placebo (control drug) in this trial. Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks. Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial. |
|
|
|
| OG002 | Baseline | Prior to randomization, a baseline/screening visit was performed. |
|
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|
|
|
|
| OG002 | Baseline | Prior to randomization/first visit |
|
|
|
| OG002 | Baseline | Prior to randomization/first visit |
|
|
|
| OG002 | Baseline | Prior to randomization/first visit |
|
|
|
|
|
|
|
| OG002 | Baseline | Prior to randomization/first visit |
|