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The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and quality of life in patients with chronic heart failure with reduced systolic function.
A 12-week randomized, double-blind, placebo-controlled trial to evaluate the effects of once-daily dapagliflozin 10 mg on heart failure disease-specific biomarkers (BNP and NTproBNP), symptoms, health status, and quality of life in patients with chronic heart failure with reduced systolic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Active Comparator | Dapagliflozin 10 mg daily |
|
| Dapagliflozin matching placebo | Placebo Comparator | Dapagliflozin matching placebo 10 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug |
|
| |
| Dapagliflozin matching placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP). | Difference in the average of the 6- and 12-week mean N-terminal pro B-type natriuretic peptide (NTproBNP). | Average of Week 6 and Week 12 |
| Percentage of Patients That Achieve a ≥ 5-point Increase in Heart Failure Disease Specific Quality of Life (Assessed Using Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)) or a ≥ 20% Decrease in NTproBNP Over 12 Weeks | A composite of the percentage of patients that achieved a meaningful improvement in health status (≥5-point increase in average of 6- and 12-week KCCQ-OS) or NT-proBNP (≥20% decrease in average of 6- and 12-week NT-proBNP). 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. For the KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points. | Average of Week 6 and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) | Percentage of patients with a ≥ 5-point increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) as measured at Week 6 and Week 12. 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. For the KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points. |
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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 |
|---|---|---|---|---|---|---|
| Heart Group of the Eastern Shore | Fairhope | Alabama | 36532 | United States | ||
| University of Southern Califiornia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31524498 | Background | Nassif ME, Windsor SL, Tang F, Khariton Y, Husain M, Inzucchi SE, McGuire DK, Pitt B, Scirica BM, Austin B, Drazner MH, Fong MW, Givertz MM, Gordon RA, Jermyn R, Katz SD, Lamba S, Lanfear DE, LaRue SJ, Lindenfeld J, Malone M, Margulies K, Mentz RJ, Mutharasan RK, Pursley M, Umpierrez G, Kosiborod M. Dapagliflozin Effects on Biomarkers, Symptoms, and Functional Status in Patients With Heart Failure With Reduced Ejection Fraction: The DEFINE-HF Trial. Circulation. 2019 Oct 29;140(18):1463-1476. doi: 10.1161/CIRCULATIONAHA.119.042929. Epub 2019 Sep 16. | |
| 39421941 |
| Label | URL |
|---|---|
| Drug information for dapagliflozin | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapagliflozin | Dapagliflozin 10 mg daily Dapagliflozin |
| FG001 | Dapagliflozin Matching Placebo | Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Nov 4, 2017 | Sep 10, 2021 |
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| Drug |
|
|
| Baseline to Week 6 and Week 12 |
| Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) | Percentage of patients with a ≥ 20% decrease in NTproBNP as measured at Week 6 and Week 12. | Baseline to Week 6 and Week 12 |
| Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS) and a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) | 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. For the KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points. | Average of Week 6 and Week 12 |
| Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks. | Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) over 12 weeks as measured at Week 6 and Week 12.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. For the KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points. | Baseline to Week 6 and Week 12 |
| Change in 6 Minute Walk Score Over 12 Weeks. | Change in 6 minute walk score over 12 weeks as measured at Week 6 and Week 12. The 6 minute walk test measures the distance in meters that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. | Baseline to Week 6 and Week 12 |
| Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks. | Change in BNP over 12 weeks as measured at Week 6 and Week 12 as measured at Week 6 and Week 12. | Baseline to Week 6 and Week 12 |
| Change in Hemoglobin A1c (HbA1c) Over 12 Weeks. | Change in HbA1c over 12 weeks as measured at Week 6 and Week 12. | Baseline to Week 6 and Week 12 |
| Change in Weight Over 12 Weeks | Change in weight over 12 weeks as measured at Week 6 and Week 12. | Baseline to Week 6 and Week 12 |
| Change in Systolic Blood Pressure Over 12 Weeks | Change in systolic blood pressure over 12 weeks as measured at Week 6 and Week 12. | Baseline to Week 6 and Week 12 |
| Los Angeles |
| California |
| 90032 |
| United States |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32256 | United States |
| Charlotte Heart Group Research Center | Port Charlotte | Florida | 33952 | United States |
| Emory University | Atlanta | Georgia | 30303 | United States |
| NorthShore University HealthSystem Research Institute | Evanston | Illinois | 60201 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| Advocate Health and Hospitals | Oakbrook Terrace | Illinois | 60181 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Freeman Health System | Joplin | Missouri | 64804 | United States |
| Truman Medical Center | Kansas City | Missouri | 64108 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| New York University | New York | New York | 10016 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Eastern Nephrology Associates | New Bern | North Carolina | 28562 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19106 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| Derived |
| Selvaraj S, Patel S, Sauer AJ, McGarrah RW, Jones P, Kwee LC, Windsor SL, Ilkayeva O, Muehlbauer MJ, Newgard CB, Borlaug BA, Kitzman DW, Shah SJ, Margulies KB, Husain M, Inzucchi SE, McGuire DK, Lanfear DE, Javaheri A, Umpierrez G, Mentz RJ, Sharma K, Kosiborod MN, Shah SH. Metabolic Effects of the SGLT2 Inhibitor Dapagliflozin in Heart Failure Across the Spectrum of Ejection Fraction. Circ Heart Fail. 2024 Nov;17(11):e011980. doi: 10.1161/CIRCHEARTFAILURE.124.011980. Epub 2024 Oct 18. |
| 37203441 | Derived | Nassif ME, Windsor SL, Gosch K, Borlaug BA, Husain M, Inzucchi SE, Kitzman DW, McGuire DK, Pitt B, Scirica BM, Shah SJ, Umpierrez G, Austin BA, Lamba S, Khumri T, Sharma K, Kosiborod MN. Dapagliflozin Improves Heart Failure Symptoms and Physical Limitations Across the Full Range of Ejection Fraction: Pooled Patient-Level Analysis From DEFINE-HF and PRESERVED-HF Trials. Circ Heart Fail. 2023 Jul;16(7):e009837. doi: 10.1161/CIRCHEARTFAILURE.122.009837. Epub 2023 May 19. |
| 35603596 | Derived | Selvaraj S, Fu Z, Jones P, Kwee LC, Windsor SL, Ilkayeva O, Newgard CB, Margulies KB, Husain M, Inzucchi SE, McGuire DK, Pitt B, Scirica BM, Lanfear DE, Nassif ME, Javaheri A, Mentz RJ, Kosiborod MN, Shah SH; DEFINE-HF Investigators. Metabolomic Profiling of the Effects of Dapagliflozin in Heart Failure With Reduced Ejection Fraction: DEFINE-HF. Circulation. 2022 Sep 13;146(11):808-818. doi: 10.1161/CIRCULATIONAHA.122.060402. Epub 2022 May 23. |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dapagliflozin | Dapagliflozin 10 mg daily Dapagliflozin |
| BG001 | Dapagliflozin Matching Placebo | Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 |
| |||||||||||||||
| Previous 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 mellitus | Count of Participants | Participants |
| ||||||||||||||||
| Atrial Fibrillation | Count of Participants | Participants |
| ||||||||||||||||
| Internal Cardiac Defibrillator (ICD) | Count of Participants | Participants |
| ||||||||||||||||
| Cardiac resynchronization therapy (CRT) | Count of Participants | Participants |
| ||||||||||||||||
| Angiotensin converting enzyme inhibitor (ACEI) / Angiotensin II receptor blocker (ARB) | Count of Participants | Participants |
| ||||||||||||||||
| Angiotensin receptor-neprilysin inhibitor (ARNI) | Count of Participants | Participants |
| ||||||||||||||||
| β-blockers | Count of Participants | Participants |
| ||||||||||||||||
| Hydralazine | Count of Participants | Participants |
| ||||||||||||||||
| Long-acting nitrates | Count of Participants | Participants |
| ||||||||||||||||
| Mineralocorticoid receptor agonist (MRA) | Count of Participants | Participants |
| ||||||||||||||||
| Loop diuretics | Count of Participants | Participants |
| ||||||||||||||||
| Digoxin | Count of Participants | Participants |
| ||||||||||||||||
| Lipid-lowering agents | Count of Participants | Participants |
| ||||||||||||||||
| Anticoagulant agent | Count of Participants | Participants |
| ||||||||||||||||
| Insulin - among patients with type 2 diabetes | Count of Participants | Participants | No |
| |||||||||||||||
| Glucagon-like peptide-1 receptor agonist (GLP-1RA ) - among patients with type 2 diabetes | Count of Participants | Participants | No |
| |||||||||||||||
| Dipeptidyl Pepdidase 4 (DPP4) inhibitor - among patients with type 2 diabetes | Count of Participants | Participants | No |
| |||||||||||||||
| Sulfonylurea - among patients with type 2 diabetes | Count of Participants | Participants | No |
| |||||||||||||||
| Metformin - among patients with type 2 diabetes | Count of Participants | Participants | No |
| |||||||||||||||
| Body mass index | Median | Inter-Quartile Range | kg/m^2 |
| |||||||||||||||
| Heart rate | Mean | Standard Deviation | beats per minute |
| |||||||||||||||
| Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
| |||||||||||||||
| N-terminal pro B-type natriuretic peptide (NT-proBNP) | Median | Inter-Quartile Range | pg/mL |
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| Brain natriuretic peptide (BNP) | Median | Inter-Quartile Range | pg/mL |
| |||||||||||||||
| Estimated glomerular filtration rate (eGFR) | Mean | Standard Deviation | mL/min/1.73m2 |
| |||||||||||||||
| Urine Albumin/Creatinine Ratio | Mean | Inter-Quartile Range | mg/g |
| |||||||||||||||
| Hemoglobin A1c | Mean | Standard Deviation | % |
| |||||||||||||||
| Hemoglobin | Mean | Standard Deviation | g/dL |
| |||||||||||||||
| New York Heart Association (NYHA) Class II | New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. A higher class means a worse functional condition. NYHA Class II indicates 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 |
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| New York Heart Association (NYHA) Class III | New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. A higher class means a worse functional condition. 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 | score on a scale |
| ||||||||||||||
| 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 | score on a scale |
| ||||||||||||||
| 6-minute walk distance | Median | Inter-Quartile Range | meters |
|
| 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 the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP). | Difference in the average of the 6- and 12-week mean N-terminal pro B-type natriuretic peptide (NTproBNP). | 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 | Mean | 95% Confidence Interval | pg/dL | Average of Week 6 and Week 12 |
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| Primary | Percentage of Patients That Achieve a ≥ 5-point Increase in Heart Failure Disease Specific Quality of Life (Assessed Using Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)) or a ≥ 20% Decrease in NTproBNP Over 12 Weeks | A composite of the percentage of patients that achieved a meaningful improvement in health status (≥5-point increase in average of 6- and 12-week KCCQ-OS) or NT-proBNP (≥20% decrease in average of 6- and 12-week NT-proBNP). 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. For the KCCQ overall summary score, 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 | Number | % of participants | Average of Week 6 and Week 12 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) | Percentage of patients with a ≥ 5-point increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) as measured at Week 6 and Week 12. 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. For the KCCQ overall summary score, 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 |
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| Secondary | Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) | Percentage of patients with a ≥ 20% decrease in NTproBNP as measured at Week 6 and Week 12. | 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 | Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS) and a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) | 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. For the KCCQ overall summary score, 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 | Average of Week 6 and Week 12 |
|
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| Secondary | Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks. | Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) over 12 weeks as measured at Week 6 and Week 12.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. For the KCCQ overall summary score, 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 | Mean | 95% Confidence Interval | score on a scale | Baseline to Week 6 and Week 12 |
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| Secondary | Change in 6 Minute Walk Score Over 12 Weeks. | Change in 6 minute walk score over 12 weeks as measured at Week 6 and Week 12. The 6 minute walk test measures the distance in meters that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. | 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 | Mean | 95% Confidence Interval | meters | Baseline to Week 6 and Week 12 |
|
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| Secondary | Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks. | Change in BNP over 12 weeks as measured at Week 6 and Week 12 as measured at Week 6 and Week 12. | 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 | Mean | 95% Confidence Interval | pg/mL | Baseline to Week 6 and Week 12 |
|
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| Secondary | Change in Hemoglobin A1c (HbA1c) Over 12 Weeks. | Change in HbA1c over 12 weeks as measured at Week 6 and Week 12. | The number analyzed may differ from the overall number analyzed due to missing data at certain timepoints for some participants. | Posted | Mean | 95% Confidence Interval | percentage of glycated hemoglobin | Baseline to Week 6 and Week 12 |
|
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| Secondary | Change in Weight Over 12 Weeks | Change in weight over 12 weeks as measured at Week 6 and Week 12. | 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 | Mean | 95% Confidence Interval | kg | Baseline to Week 6 and Week 12 |
|
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| Secondary | Change in Systolic Blood Pressure Over 12 Weeks | Change in systolic blood pressure over 12 weeks as measured at Week 6 and Week 12. | 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 | Mean | 95% Confidence Interval | mm Hg | Baseline to Week 6 and Week 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.
Serious Adverse Events, Drug Adverse Events, Adverse Events of Special Interest and Urgent Outpatient Heart Failure Visits were collected. A Drug Adverse Event is an adverse event which leads to premature and permanent discontinuation of study medication. Adverse Events of Special Interest include diabetic ketoacidosis, volume depletion (defined as hypotension, syncope, orthostatic hypotension or dehydration), severe hypoglycemic events and 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 | Dapagliflozin | Dapagliflozin 10 mg daily Dapagliflozin | 1 | 131 | 32 | 131 | 19 | 131 |
| EG001 | Dapagliflozin Matching Placebo | Dapagliflozin matching placebo 10 mg daily Dapagliflozin matching placebo | 1 | 132 | 31 | 132 | 18 | 132 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation of Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal Pain | General disorders | Systematic Assessment |
| ||
| Acute Dyspnea | General disorders | Systematic Assessment |
| ||
| Acute Kidney Injury | General disorders | Systematic Assessment |
| ||
| Acute Respiratory Distress | General disorders | Systematic Assessment |
| ||
| Acute Respiratory Failure | General disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atypical Chest Pain | General disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cachexia | General disorders | Systematic Assessment |
| ||
| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
| ||
| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
| ||
| Cerebrovascular Accident | General disorders | Systematic Assessment |
| ||
| Chest Pain | General disorders | Systematic Assessment |
| ||
| Cirrhosis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cocaine Abuse | General disorders | Systematic Assessment |
| ||
| Elevated Cardiac Enzymes | Cardiac disorders | Systematic Assessment |
| ||
| Epistaxis | General disorders | Systematic Assessment |
| ||
| Exacerbation of COPD | General disorders | Systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gout | General disorders | Systematic Assessment |
| ||
| Herpes Zoster | Infections and infestations | Systematic Assessment |
| ||
| Hypertensive Urgency | General disorders | Systematic Assessment |
| ||
| ICD Implantation | Cardiac disorders | Systematic Assessment |
| ||
| ICD Shock due to Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Left Great Toe Infection | Infections and infestations | Systematic Assessment |
| ||
| Morbid Obesity - Remove Laparoscopic band | General disorders | Systematic Assessment |
| ||
| Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Non Intractable Headache | General disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pre-Renal Acute Kidney Injury | General disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock secondary to purulent skin infection from herpes zoster | General disorders | Systematic Assessment |
| ||
| Sudden Death | General disorders | Systematic Assessment |
| ||
| Syncope | General disorders | Systematic Assessment |
| ||
| Transient Ischemic Attack | General disorders | Systematic Assessment |
| ||
| Urinary Tract Infection | General disorders | Systematic Assessment |
| ||
| Ventricular Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
| ||
| Volume Depletion | General disorders | Systematic Assessment |
| ||
| Worsening Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
| ||
| Worsening Peripheral Artery Disease | General disorders | Systematic Assessment |
| ||
| Oliguric Acute Kidney Injury on CKD III | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urgent Heart Failure Visit | Cardiac disorders | Systematic Assessment |
| ||
| Volume Depletion | General disorders | Systematic Assessment |
| ||
| Severe Hypoglycemia | Endocrine disorders | Systematic Assessment |
| ||
| Hypotension | General disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Syncope | General disorders | Systematic Assessment |
| ||
| Urinary Tract Infection | General disorders | Systematic Assessment |
| ||
| Vaginal Discharge | General disorders | Systematic Assessment |
| ||
| Bullae | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Atypical Chest Pain | General disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Program Manager, Cardiometabolic Research | Saint Luke's Hospital of Kansas City | 8166957561 | DEFINE-HF@saint-lukes.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2019 | Sep 10, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529054 | dapagliflozin |
Not provided
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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