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The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, on hemodynamic parameters (pulmonary artery diastolic pressure) in patients with heart failure (reduced or preserved ejection fraction, ischemic or non-ischemic etiology) who already have a CardioMEMs device (a wireless hemodynamic monitoring system) implanted for non-study related clinical reasons.
A 12-week randomized, double-blind, placebo-controlled trial to explore the effects of once-daily empagliflozin 10 mg on hemodynamic parameters (pulmonary artery pressures) in patients with heart failure (reduced or preserved ejection fraction, ischemic or non-ischemic etiology) who already have a CardioMEMs device implanted for non-study related clinical reasons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin | Active Comparator | Empagliflozin 10 mg tab, once daily, for 12 weeks |
|
| Placebo | Placebo Comparator | Empagliflozin matching placebo oral tablet, once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 mg Tab | Drug | Empagliflozin 10 mg Tab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulmonary Artery Diastolic Pressure From Baseline to End of Treatment Period (Defined as Average of Pulmonary Artery Diastolic Pressure Measurements Between Weeks 8-12) Between Empagliflozin and Placebo | Change in pulmonary artery diastolic pressure from baseline to end of treatment period (defined as average of pulmonary artery diastolic pressure measurements between weeks 8-12) between empagliflozin and placebo | Baseline to average between Weeks 8-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Change from baseline in pulmonary artery diastolic pressure at each interim timepoint (wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) between empagliflozin and placebo. | Baseline to Weeks 1-12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail Kosiborod, MD | Saint Luke's Mid America Heart Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| First Coast Cardiovascular Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33550815 | Result | Nassif ME, Qintar M, Windsor SL, Jermyn R, Shavelle DM, Tang F, Lamba S, Bhatt K, Brush J, Civitello A, Gordon R, Jonsson O, Lampert B, Pelzel J, Kosiborod MN. Empagliflozin Effects on Pulmonary Artery Pressure in Patients With Heart Failure: Results From the EMBRACE-HF Trial. Circulation. 2021 Apr 27;143(17):1673-1686. doi: 10.1161/CIRCULATIONAHA.120.052503. Epub 2021 Feb 8. | |
| 34696602 |
| Label | URL |
|---|---|
| Empagliflozin information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Empagliflozin | Empagliflozin 10 mg tab, once daily, for 12 weeks Empagliflozin 10 mg Tab: Empagliflozin 10 mg Tab |
| FG001 | Placebo | Empagliflozin matching placebo oral tablet, once daily for 12 weeks Placebo Oral Tablet: Empagliflozin matching placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Empagliflozin | Empagliflozin 10 mg tab, once daily, for 12 weeks Empagliflozin 10 mg Tab: Empagliflozin 10 mg Tab |
| BG001 | Placebo | Empagliflozin matching placebo oral tablet, once daily for 12 weeks Placebo Oral Tablet: Empagliflozin matching placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Pulmonary Artery Diastolic Pressure From Baseline to End of Treatment Period (Defined as Average of Pulmonary Artery Diastolic Pressure Measurements Between Weeks 8-12) Between Empagliflozin and Placebo | Change in pulmonary artery diastolic pressure from baseline to end of treatment period (defined as average of pulmonary artery diastolic pressure measurements between weeks 8-12) between empagliflozin and placebo | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline to average between Weeks 8-12 |
|
Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period.
All adverse events were collected including Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits. A Drug Adverse Events is an adverse event which leads to premature and permanent discontinuation of study drug. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion, severe hypoglycemic events and non-traumatic lower limb amputations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Empagliflozin | Empagliflozin 10 mg tab, once daily, for 12 weeks Empagliflozin 10 mg Tab: Empagliflozin 10 mg Tab |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation of Heart Failure | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Manager | Saint Luke's Hospital of Kansas City | 816-932-9858 | EMBRACE-HF@saint-lukes.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 24, 2018 | Sep 22, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2020 | Sep 22, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Placebo Oral Tablet | Drug | Empagliflozin matching placebo |
|
|
| Change in Pulmonary Artery Systolic Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo. | Change in pulmonary artery systolic pressure from baseline to end of treatment period (week 12) between empagliflozin and placebo. | Baseline to Week 12 |
| Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Change from baseline in pulmonary artery systolic pressure at each interim time point (wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) between empagliflozin and placebo. | Baseline to Weeks 1-12 |
| Change in Mean Pulmonary Artery Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo. | Change in mean pulmonary artery pressure from baseline to end of treatment period (week 12) between empagliflozin and placebo. | Baseline to Week 12 |
| Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Change from baseline in mean pulmonary artery pressure at each interim time point (weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) between empagliflozin and placebo. | Baseline to Weeks 1-12 |
| Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points. | Baseline to Week 6 and Week 12 |
| Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points. | Baseline to Week 6 and Week 12 |
| Change in 6 Minute Walk Test From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Change in 6 minute walk test from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo. | Baseline to Week 6 and Week 12 |
| Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo. | Baseline to Week 6 and Week 12 |
| Change in Brain Natriuretic Peptide (BNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Change in brain natriuretic peptide (BNP) from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo. | Baseline to Week 6 and Week 12 |
| Proportion of Patients With a ≥ 20% Decrease From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | Proportion of patients with a ≥ 20% decrease from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. | Baseline to Week 6 and Week 12 |
| Proportion of Patients With a ≥ 20% Decrease From Baseline in Brain Natriuretic Peptide (BNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | Proportion of patients with a ≥ 20% decrease from baseline in brain natriuretic peptide (BNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. | Baseline to Week 6 and Week 12 |
| Proportion of Patients With Both a ≥ 5 Point Increase From Baseline in KCCQ-OS and a ≥ 20% Decrease From Baseline in NT-proBNP at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | Proportion of patients with both a ≥ 5 point increase from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) and a ≥ 20% decrease from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points. | Baseline to Week 6 and Week 12 |
| Number of Participants With Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo | Number of Participants with Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo | Baseline to Week 12 |
| Change in Hemoglobin A1c From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Change in Hemoglobin A1c from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo. | Baseline to Week 6 and Week 12 |
| Jacksonville |
| Florida |
| 32256 |
| United States |
| NorthShore University Health System Research Institute | Evanston | Illinois | 60201 | United States |
| CentraCare Heart and Vascular Center | Saint Cloud | Minnesota | 56303 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Sanford Research | Sioux Falls | South Dakota | 57104 | United States |
| Austin Heart Clinical Research | Austin | Texas | 78756 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Sentara Cardiovascular Research Institute | Norfolk | Virginia | 23507 | United States |
| Derived |
| Nassif ME, Spertus JA, Tang F, Windsor SL, Jones P, Thomas M, Khariton Y, Brush J, Gordon RA, Jermyn R, Jonsson O, Lamba S, Shavelle DM, Kosiborod MN. Association Between Change in Ambulatory Hemodynamic Pressures and Symptoms of Heart Failure. Circ Heart Fail. 2021 Nov;14(11):e008446. doi: 10.1161/CIRCHEARTFAILURE.121.008446. Epub 2021 Oct 26. No abstract available. |
| 31081589 | Derived | Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of Heart Failure | Mean | Standard Deviation | years |
|
| Prior hospitalization for heart failure | Count of Participants | Participants |
|
| Time since last hospitalization for heart failure | Mean | Standard Deviation | years |
|
| Ejection fraction | Mean | Standard Deviation | % |
|
| Ischemic heart disease | Count of Participants | Participants |
|
| Type 2 Diabetes | Count of Participants | Participants |
|
| Atrial Fibrillation | Count of Participants | Participants |
|
| Implantable cardioverter defibrillator (ICD) | Count of Participants | Participants |
|
| Cardiac resynchronization therapy (CRT) | Count of Participants | Participants |
|
| Pulmonary Artery Diastolic Pressure | Mean | Standard Deviation | mm Hg |
|
| Angiotensin-converting enzyme inhibitor / Angiotensin II receptor blocker (ACEI/ARB) | Count of Participants | Participants |
|
| Angiotensin receptor-neprilysin inhibitor (ARNI) | Count of Participants | Participants |
|
| Beta blockers | Count of Participants | Participants |
|
| Hydralazine | Count of Participants | Participants |
|
| Long-acting nitrates | Count of Participants | Participants |
|
| Mineralocorticoid receptor antagonist (MRA) | Count of Participants | Participants |
|
| Loop diuretics | Count of Participants | Participants |
|
| Digoxin | Count of Participants | Participants |
|
| Lipid lowering agent | Count of Participants | Participants |
|
| Anticoagulant agent | Count of Participants | Participants |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Heart rate | Mean | Standard Deviation | bpm |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| N-terminal pro b-type natriuretic peptide (NT-proBNP) | Median | Inter-Quartile Range | pg/mL |
|
| Brain natriuretic peptide (BNP) | Median | Inter-Quartile Range | pg/mL |
|
| Estimated glomerular filtration rate (eGFR) | Mean | Standard Deviation | mL/min/1.73m^2 |
|
| Urine Albumin/Creatinine Ratio | Mean | Standard Deviation | mg/g |
|
| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | percentage of hemoglobin |
|
| Hemoglobin | Mean | Standard Deviation | g/dL |
|
| New York Heart Association (NYHA) Class II | Doctors usually classify patients' heart failure according to the severity of their symptoms. The most commonly used classification system is the New York Heart Association (NYHA) Functional Classification. It places patients in one of four categories based on how much they are limited during physical activity. NYHA Class II means the patient has been classified as having slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). | Count of Participants | Participants |
|
| New York Heart Association (NYHA) Class III | Doctors usually classify patients' heart failure according to the severity of their symptoms. The most commonly used classification system is the New York Heart Association (NYHA) Functional Classification. It places patients in one of four categories based on how much they are limited during physical activity. NYHA Class III indicates the patient has been classified as having Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. | Count of Participants | Participants |
|
| Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS) | The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. | Mean | Standard Deviation | points |
|
| Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CS) | The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. | Mean | Standard Deviation | points |
|
| 6-minute walk distance | Median | Inter-Quartile Range | meters |
|
| Insulin (among patients with type 2 diabetes) | Insulin use among patients with type 2 diabetes. | Count of Participants | Participants |
|
| Glucagon-like peptide-1 receptor agonist (GLP-1 RA )(among patients with type 2 diabetes) | GLP-1RA use among patients with type 2 diabetes. | Count of Participants | Participants |
|
| Dipeptidyl-peptidase 4 (DPP4) inhibitor (among patients with type 2 diabetes) | DPP4-inhibitor use among patients with type 2 diabetes. | Count of Participants | Participants |
|
| Sulfonylurea (among patients with type 2 diabetes) | Sulfonylurea use among patients with type 2 diabetes. | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Change from baseline in pulmonary artery diastolic pressure at each interim timepoint (wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) between empagliflozin and placebo. | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline to Weeks 1-12 |
|
|
|
| Secondary | Change in Pulmonary Artery Systolic Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo. | Change in pulmonary artery systolic pressure from baseline to end of treatment period (week 12) between empagliflozin and placebo. | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline to Week 12 |
|
|
|
| Secondary | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Change from baseline in pulmonary artery systolic pressure at each interim time point (wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) between empagliflozin and placebo. | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline to Weeks 1-12 |
|
|
|
| Secondary | Change in Mean Pulmonary Artery Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo. | Change in mean pulmonary artery pressure from baseline to end of treatment period (week 12) between empagliflozin and placebo. | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline to Week 12 |
|
|
|
| Secondary | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Change from baseline in mean pulmonary artery pressure at each interim time point (weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) between empagliflozin and placebo. | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline to Weeks 1-12 |
|
|
|
| Secondary | Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to Week 6 and Week 12 |
|
|
|
| Secondary | Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points. | The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants. | Posted | Count of Participants | Participants | Baseline to Week 6 and Week 12 |
|
|
|
| Secondary | Change in 6 Minute Walk Test From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Change in 6 minute walk test from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo. | Posted | Mean | 95% Confidence Interval | meters | Baseline to Week 6 and Week 12 |
|
|
|
| Secondary | Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo. | Posted | Mean | 95% Confidence Interval | pg/mL | Baseline to Week 6 and Week 12 |
|
|
|
| Secondary | Change in Brain Natriuretic Peptide (BNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Change in brain natriuretic peptide (BNP) from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo. | Posted | Mean | 95% Confidence Interval | pg/mL | Baseline to Week 6 and Week 12 |
|
|
|
| Secondary | Proportion of Patients With a ≥ 20% Decrease From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | Proportion of patients with a ≥ 20% decrease from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. | The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants. | Posted | Count of Participants | Participants | Baseline to Week 6 and Week 12 |
|
|
|
| Secondary | Proportion of Patients With a ≥ 20% Decrease From Baseline in Brain Natriuretic Peptide (BNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | Proportion of patients with a ≥ 20% decrease from baseline in brain natriuretic peptide (BNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. | The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants. | Posted | Count of Participants | Participants | Baseline to Week 6 and Week 12 |
|
|
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| Secondary | Proportion of Patients With Both a ≥ 5 Point Increase From Baseline in KCCQ-OS and a ≥ 20% Decrease From Baseline in NT-proBNP at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | Proportion of patients with both a ≥ 5 point increase from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) and a ≥ 20% decrease from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points. | Posted | Count of Participants | Participants | Baseline to Week 6 and Week 12 |
|
|
|
| Secondary | Number of Participants With Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo | Number of Participants with Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo | Posted | Count of Participants | Participants | Baseline to Week 12 |
|
|
|
| Secondary | Change in Hemoglobin A1c From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Change in Hemoglobin A1c from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo. | Posted | Mean | 95% Confidence Interval | percentage of hemoglobin | Baseline to Week 6 and Week 12 |
|
|
|
| 1 |
| 33 |
| 8 |
| 33 |
| 19 |
| 33 |
| EG001 | Placebo | Empagliflozin matching placebo oral tablet, once daily for 12 weeks Placebo Oral Tablet: Empagliflozin matching placebo | 0 | 32 | 9 | 32 | 16 | 32 |
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Head Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
|
| Groin Abcess | Infections and infestations | Systematic Assessment |
|
| Hematuria | General disorders | Systematic Assessment |
|
| Hypotension | General disorders | Systematic Assessment |
|
| Osteoarthritis - left knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Volume Depletion | General disorders | Systematic Assessment |
|
| Worsening Tricuspid Valve Regurgitation | Cardiac disorders | Systematic Assessment |
|
| Endocarditis | Cardiac disorders | Systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| CardioMEMS device recalibration | General disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Cellulitis - bilateral legs | Infections and infestations | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Congestion | General disorders | Systematic Assessment |
|
| Contusion - scalp | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cough | General disorders | Systematic Assessment |
|
| Dysuria | General disorders | Systematic Assessment |
|
| Exacerbation of Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Exertional Angina | Cardiac disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Gout Flare | General disorders | Systematic Assessment |
|
| Hiccups | General disorders | Systematic Assessment |
|
| Asymptomatic hypoglycemia | Endocrine disorders | Systematic Assessment |
|
| Hypokalemia | General disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Increased craving for sweets | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Pulmonary Nodule | General disorders | Systematic Assessment |
|
| Quick Tempered | General disorders | Systematic Assessment |
|
| Abscess - bilateral - hips, buttocks and upper legs | Infections and infestations | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Lower left extremity swelling | General disorders | Systematic Assessment |
|
| Vaginal Yeast Infection | Infections and infestations | Systematic Assessment |
|
| Vertigo | General disorders | Systematic Assessment |
|
| Volume Depletion | General disorders | Systematic Assessment |
|
| Worsening Gout | General disorders | Systematic Assessment |
|
| Wound Dehiscence | General disorders | Systematic Assessment |
|
| Bilateral Handshaking | General disorders | Systematic Assessment |
|
| Bloating | General disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Bursitis - left knee | General disorders | Systematic Assessment |
|
| Cerumen Impaction | General disorders | Systematic Assessment |
|
| Chest Discomfort | General disorders | Systematic Assessment |
|
| Decreased renal function | General disorders | Systematic Assessment |
|
| Deep Vein Thrombosis | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Dystrophic Toenails | General disorders | Systematic Assessment |
|
| Flu | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Heart Palpitations | Cardiac disorders | Systematic Assessment |
|
| ICD Battery Depletion | General disorders | Systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| Lightheadedness | General disorders | Systematic Assessment |
|
| Melena | General disorders | Systematic Assessment |
|
| Restrictive Ventilatory Defect | General disorders | Systematic Assessment |
|
| Sick Sinus Syndrome | Cardiac disorders | Systematic Assessment |
|
| Urinary Frequency | General disorders | Systematic Assessment |
|
| Urinary Tract Infection | General disorders | Systematic Assessment |
|
| Worsening Edema | General disorders | Systematic Assessment |
|
| Worsening Urinary Urge Incontinence | General disorders | Systematic Assessment |
|
| Wrist Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Contusion - posterior lower left back | Injury, poisoning and procedural complications | Systematic Assessment |
|
Subsites will not publish until after all multicenter articles have been submitted for publication. Sponsor will have 18 months after the close of the Study at all sites to arrange for the submission of multicenter publications. If such multicenter publications are not submitted within 24 months after conclusion of the Study at all sites, Site Investigator and Subsite may publish the results from the Subsite's data, individually, pursuant to approval by Sponsor and Steering Committee.
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Pulmonary artery diastolic pressure - Week 2 |
|
| Pulmonary artery diastolic pressure - Week 3 |
|
| Pulmonary artery diastolic pressure - Week 4 |
|
| Pulmonary artery diastolic pressure - Week 5 |
|
| Pulmonary artery diastolic pressure - Week 6 |
|
| Pulmonary artery diastolic pressure - Week 7 |
|
| Pulmonary artery diastolic pressure - Week 8 |
|
| Pulmonary artery diastolic pressure - Week 9 |
|
| Pulmonary artery diastolic pressure - Week 10 |
|
| Pulmonary artery diastolic pressure - Week 11 |
|
| Pulmonary artery diastolic pressure - Week 12 |
|
| Pulmonary artery systolic pressure - Week 2 |
|
| Pulmonary artery systolic pressure - Week 3 |
|
| Pulmonary artery systolic pressure - Week 4 |
|
| Pulmonary artery systolic pressure - Week 5 |
|
| Pulmonary artery systolic pressure - Week 6 |
|
| Pulmonary artery systolic pressure - Week 7 |
|
| Pulmonary artery systolic pressure - Week 8 |
|
| Pulmonary artery systolic pressure - Week 9 |
|
| Pulmonary artery systolic pressure - Week 10 |
|
| Pulmonary artery systolic pressure - Week 11 |
|
| Pulmonary artery systolic pressure - Week 12 |
|
| Pulmonary artery pressure - Week 2 |
|
| Pulmonary artery pressure - Week 3 |
|
| Pulmonary artery pressure - Week 4 |
|
| Pulmonary artery pressure - Week 5 |
|
| Pulmonary artery pressure - Week 6 |
|
| Pulmonary artery pressure - Week 7 |
|
| Pulmonary artery pressure - Week 8 |
|
| Pulmonary artery pressure - Week 9 |
|
| Pulmonary artery pressure - Week 10 |
|
| Pulmonary artery pressure - Week 11 |
|
| Pulmonary artery pressure - Week 12 |
|
| Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) score - 6 weeks |
|
| Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) score - 12 weeks |
|
| KCCQ-OS score increase >/= 5 points (12 weeks) |
|
|
| KCCQ-CS score increase >/= 5 points (6 weeks) |
|
|
| KCCQ-CS score increase >/= 5 points (12 weeks) |
|
|
| NT-proBNP decrease >/= 20% - 12 weeks |
|
|
| BNP decrease >/= 20% - 12 weeks |
|
|