Phase 4
Completed N=263
Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure
Chronic Heart Failure With Reduced Systolic Function
Source: ClinicalTrials.gov NCT02653482 ↗
Enrolled (actual)
263
Serious AEs
24.0%
Results posted
Dec 2021
Primary outcomePrimary: Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP). — 1133; 1191 pg/dL
◆ Published Evidence
Highly cited
425citations · ~61 / year
Dapagliflozin Effects on Biomarkers, Symptoms, and Functional Status in Patients With Heart Failure With Reduced Ejection Fraction: The DEFINE-HF Trial.
Summary
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.
Linked Publications (5)
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Dapagliflozin Effects on Biomarkers, Symptoms, and Functional Status in Patients With Heart Failure With Reduced Ejection Fraction: The DEFINE-HF Trial.
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Metabolomic Profiling of the Effects of Dapagliflozin in Heart Failure With Reduced Ejection Fraction: DEFINE-HF.
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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.
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Effects of sodium glucose cotransporter type 2 inhibitors on heart failure.
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Metabolic Effects of the SGLT2 Inhibitor Dapagliflozin in Heart Failure Across the Spectrum of Ejection Fraction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP). |
1133; 1191 | — |
| 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 |
61.5; 50.4 | — |
| SECONDARY Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) |
59; 46; 54; 41 | — |
| SECONDARY Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) |
43; 42; 55; 37 | — |
| 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) |
20; 17 | — |
| SECONDARY Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks. |
71.1; 70.1; 72.6; 68.9 | — |
| SECONDARY Change in 6 Minute Walk Score Over 12 Weeks. |
297.1; 289.6; 303.7; 301.3 | — |
| SECONDARY Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks. |
236; 265; 228; 272 | — |
| SECONDARY Change in Hemoglobin A1c (HbA1c) Over 12 Weeks. |
6.9; 7.1; 6.9; 7.1 | — |
| SECONDARY Change in Weight Over 12 Weeks |
96.0; 96.6; 96.3; 96.6 | — |
| SECONDARY Change in Systolic Blood Pressure Over 12 Weeks |
119.2; 121.1; 120.9; 119.8 | — |
Eligibility Criteria
Inclusion Criteria
- Established diagnosis of New York Heart Association (NYHA) Class II or Class III heart failure (left ventricular ejection fraction ≤40% due to either ischemic or non-ischemic etiology) with reduced systolic function for at least 16 weeks prior to enrollment
- No change in diuretic management for at least 1 week prior to enrollment
- Brain natriuretic peptide (BNP) ≥100 pg/mL and/or N-terminal pro b-type natriuretic peptide (NTproBNP) ≥ 400 pg/mL at enrollment
Exclusion Criteria
- History of type 1 diabetes
- Estimated glomerular filtration rate (eGFR) < 30 at enrollment
- Hospitalization for heart failure within the 30 days prior to enrollment
- Admission for an acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within the 30 days prior to enrollment
- Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
- Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy) within the 90 days after enrollment
- Patients who are volume depleted based upon physical examination at the time of screening or randomization
Data sourced from ClinicalTrials.gov (NCT02653482) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.