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| ID | Type | Description | Link |
|---|---|---|---|
| 4U10HL084904-10 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Mayo Clinic | OTHER |
| University of Vermont | OTHER |
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A randomized, double-blinded, placebo-controlled crossover study to assess effect of isosorbide mononitrate with dose up-titration on activity tolerance as assessed by (hip-worn, tri-axial) accelerometry.
To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isosorbide Mononitrate | Active Comparator | Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks) |
|
| Isosorbide Mononitate Placebo | Placebo Comparator | Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isosorbide Mononitrate | Drug | Dispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN |
| Measure | Description | Time Frame |
|---|---|---|
| Arbitrary Accelerometry Units (AAU) (Phase I) | To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. | 5-6 weeks |
| Arbitrary Accelerometry Units (AAU) (Phase II) | To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. | 11-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Six Minute Walk Distance (Phase I) | To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo. | Week 7 |
| Six Minute Walk Distance (Phase II) |
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Inclusion Criteria:
Age ≥ 50 years
Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
Ejection fraction (EF) ≥ 50% as determined on imaging study within 12 months of enrollment with no change in clinical status suggesting potential for deterioration in systolic function
Stable medical therapy for 30 days as defined by:
One of the following within the last 12 months
No chronic nitrate therapy or infrequent (≤ 1x week) use of intermittent sublingual nitroglycerin within last 3 months
Ambulatory (not wheelchair / scooter / walker / cane dependent)
HF is the primary factor limiting activity as indicated by answering # 2 to the following question:
My ability to be active is most limited by:
9. Body size allows wearing of the accelerometer belt as confirmed by ability to comfortably fasten the test belt provided for the screening process (belt designed to fit persons with BMI 20-40 Kg/m2 but belt may fit some persons outside this range)
10. Willingness to wear the accelerometer belt for the duration of the trial 11. Willingness to provide informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Anstrom, PhD | Duke Clinical Research Institute | Principal Investigator |
| Eugene Braunwald, MD | Harvard University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health Services | Newark | Delaware | 19718 | United States | ||
| Emory University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32150314 | Derived | Reddy YNV, Rikhi A, Obokata M, Shah SJ, Lewis GD, AbouEzzedine OF, Dunlay S, McNulty S, Chakraborty H, Stevenson LW, Redfield MM, Borlaug BA. Quality of life in heart failure with preserved ejection fraction: importance of obesity, functional capacity, and physical inactivity. Eur J Heart Fail. 2020 Jun;22(6):1009-1018. doi: 10.1002/ejhf.1788. Epub 2020 Mar 9. | |
| 28588021 | Derived | Snipelisky D, Kelly J, Levine JA, Koepp GA, Anstrom KJ, McNulty SE, Zakeri R, Felker GM, Hernandez AF, Braunwald E, Redfield MM. Accelerometer-Measured Daily Activity in Heart Failure With Preserved Ejection Fraction: Clinical Correlates and Association With Standard Heart Failure Severity Indices. Circ Heart Fail. 2017 Jun;10(6):e003878. doi: 10.1161/CIRCHEARTFAILURE.117.003878. |
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After the study results have been published, site-specific participant data will be shared with sites upon request. Sites are expected to follow their specific institutional policies regarding sharing results with their participants.
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All subjects who fulfill all the inclusion criteria and none of the exclusion criteria will undergo the baseline studies and then be randomized.
All patients admitted to the participating HFN centers with signs and symptoms suggestive of HFpEF will be screened including their ability to wear the accelerometer belt. Patients meeting eligibility criteria will be approached regarding participation in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Isosorbide Mononitrate Crossover to Placebo | Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks) Isosorbide Mononitrate: Dispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Placebo | Drug | Dispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo |
|
To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.
| Week 13 |
| Patient Preference for Isosorbide Mononitrate Treatment at the End of Study. | Self reported participant preference for study period 1 vs. study period 2. | Week 13 |
| Borg Score During 6 Minute Walk Test (Phase I) | To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values. | Week 7 |
| Borg Score During 6 Minute Walk Test (Phase II) | To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values. | Week 13 |
| Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase I) | To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). | Week 7 |
| Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase II) | To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. • The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).Higher values of the overall KCCQ score are considered to be better than lower values. | Week 13 |
| N-terminal Pro-B-type Natriuretic Peptide Level (Phase I) | To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo | Week 7 |
| N-terminal Pro-B-type Natriuretic Peptide Level (Phase II) | To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo | Week 13 |
| Improvement in Daily Activity - Hours Active Per Day (Phase I) | To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug | 5-6 weeks |
| Improvement in Daily Activity - Hours Active Per Day (Phase II) | To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug | 11-12 weeks |
| Improvement in Daily Activity - Slope of Daily Average (Phase I) | To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. | 3-6 weeks |
| Improvement in Daily Activity - Slope of Daily Average (Phase II) | To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. | 9-12 weeks |
| Improvement in Daily Activity - Area Under the Curve (Phase I) | To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28 | 3-6 weeks |
| Improvement in Daily Activity - Area Under the Curve (Phase II) | To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28 | 9-12 weeks |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Boston V.A. Healthcare System | West Roxbury | Massachusetts | 02132 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Metro Health System | Cleveland | Ohio | 44109 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17604 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| Jefferson Medical College | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Michael E Debakey VA Medical Center | Houston | Texas | 77030 | United States |
| University of Utah Hospitals and Clinics | Salt Lake City | Utah | 84132 | United States |
| V.A. Medical Center | Salt Lake City | Utah | 84148 | United States |
| The University of Vermont - Fletcher Allen Health Care | Burlington | Vermont | 05401 | United States |
| 26549714 | Derived | Redfield MM, Anstrom KJ, Levine JA, Koepp GA, Borlaug BA, Chen HH, LeWinter MM, Joseph SM, Shah SJ, Semigran MJ, Felker GM, Cole RT, Reeves GR, Tedford RJ, Tang WH, McNulty SE, Velazquez EJ, Shah MR, Braunwald E; NHLBI Heart Failure Clinical Research Network. Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2015 Dec 10;373(24):2314-24. doi: 10.1056/NEJMoa1510774. Epub 2015 Nov 8. |
| FG001 | Placebo Crossover to Isosorbide Mononitrate | Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks) Placebo: Dispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo |
| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Isosorbide Mononitrate Crossover to Placebo | Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks) Isosorbide Mononitrate: Dispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN |
| BG001 | Placebo Crossover to Isosorbide Mononitrate | Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks) Placebo: Dispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo |
| 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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| Region of Enrollment | Number | participants |
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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 | Arbitrary Accelerometry Units (AAU) (Phase I) | To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. | Participants with usable data included in the results | Posted | Mean | Standard Deviation | accelerometry units | 5-6 weeks |
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| ||||||||||||||||||||||||||||
| Secondary | Six Minute Walk Distance (Phase I) | To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo. | Participants with usable data included in the results | Posted | Mean | Standard Deviation | meters | Week 7 |
|
| |||||||||||||||||||||||||||||
| Secondary | Six Minute Walk Distance (Phase II) | To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo. | Participants with usable data included in the results | Posted | Mean | Standard Deviation | meters | Week 13 |
|
| |||||||||||||||||||||||||||||
| Secondary | Patient Preference for Isosorbide Mononitrate Treatment at the End of Study. | Self reported participant preference for study period 1 vs. study period 2. | Participants with usable data included in the results | Posted | Number | participants | Week 13 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Borg Score During 6 Minute Walk Test (Phase I) | To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values. | Participants with usable data included in the results | Posted | Mean | Standard Deviation | units on a scale | Week 7 |
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| Secondary | Borg Score During 6 Minute Walk Test (Phase II) | To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values. | Participants with usable data included in the results | Posted | Mean | Standard Deviation | units on a scale | Week 13 |
| ||||||||||||||||||||||||||||||
| Secondary | Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase I) | To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). | Participants with usable data included in the results | Posted | Mean | Standard Deviation | units on a scale | Week 7 |
| ||||||||||||||||||||||||||||||
| Secondary | Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase II) | To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. • The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).Higher values of the overall KCCQ score are considered to be better than lower values. | Participants with usable data included in the results | Posted | Mean | Standard Deviation | units on a scale | Week 13 |
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| Primary | Arbitrary Accelerometry Units (AAU) (Phase II) | To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. | Participants with usable data included in the results | Posted | Mean | Standard Deviation | accelerometry units | 11-12 weeks |
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| Secondary | N-terminal Pro-B-type Natriuretic Peptide Level (Phase I) | To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo | Participants with usable data included in the results | Posted | Mean | Standard Deviation | pg/mL | Week 7 |
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| Secondary | N-terminal Pro-B-type Natriuretic Peptide Level (Phase II) | To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo | Participants with usable data included in the results | Posted | Mean | Standard Deviation | pg/mL | Week 13 |
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| Secondary | Improvement in Daily Activity - Hours Active Per Day (Phase I) | To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug | Participants with usable data included in the results | Posted | Mean | Standard Deviation | Hours/day | 5-6 weeks |
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| Secondary | Improvement in Daily Activity - Hours Active Per Day (Phase II) | To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug | Participants with usable data included in the results | Posted | Mean | Standard Deviation | Hours/day | 11-12 weeks |
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| Secondary | Improvement in Daily Activity - Slope of Daily Average (Phase I) | To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. | Participants with usable data included in the results | Posted | Mean | Standard Deviation | accelerometry units/day | 3-6 weeks |
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| Secondary | Improvement in Daily Activity - Slope of Daily Average (Phase II) | To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. | Participants with usable data included in the results | Posted | Mean | Standard Deviation | accelerometry units/day | 9-12 weeks |
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| Secondary | Improvement in Daily Activity - Area Under the Curve (Phase I) | To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28 | Participants with usable data included in the results | Posted | Mean | Standard Deviation | accelerometry units | 3-6 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Improvement in Daily Activity - Area Under the Curve (Phase II) | To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28 | Participants with usable data included in the results | Posted | Mean | Standard Deviation | accelerometry units | 9-12 weeks |
|
Informed Consent through Week 15 phone visit
Per protocol, non-serious AEs were not collected; all SAEs were collected except for anticipated, disease-related events in patients with HF with preserved EF.
3 time points summarized: Informed Consent to start of Phase 1 study drug, Phase 1 study drug start to start of Phase 2 study drug, Phase 2 study drug start to Week 15 phone call.
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 | Isosorbide Mononitrate Crossover to Placebo | Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks) Isosorbide Mononitrate: Dispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN | 2 | 51 | 0 | 0 | ||
| EG001 | Placebo Crossover to Isosorbide Mononitrate | Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks) Placebo: Dispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo | 1 | 59 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Phase 1 study drug start to start of Phase 2 study drug |
|
| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | Phase 2 study drug start to Week 15 phone call |
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| Herpes Zoster | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Phase 2 study drug start to Week 15 phone call |
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| Faecaloma | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Informed consent to start of phase 1 study drug |
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| Urinary retention | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | Informed consent to start of phase 1 study drug |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adrian Hernandez | Duke Clinical Research Insitute | 919-668-7515 | Adrian.Hernandez@duke.edu |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
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| ID | Term |
|---|---|
| C030397 | isosorbide-5-mononitrate |
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Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)
Placebo: Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo
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