Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure (DEFINE-HF)

Saint Luke's Health System

Status and phase: Completed; Phase 4

Conditions: Chronic Heart Failure With Reduced Systolic Function

Treatments: Drug: Dapagliflozin; Drug: Dapagliflozin matching placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02653482

D1690C00032

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 263 patients

Sex: All

Ages: 19 to 119 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. No change in diuretic management for at least 1 week prior to enrollment
3. Brain natriuretic peptide (BNP) ≥100 pg/mL and/or N-terminal pro b-type natriuretic peptide (NTproBNP) ≥ 400 pg/mL at enrollment

Exclusion criteria

1. History of type 1 diabetes
2. Estimated glomerular filtration rate (eGFR) < 30 at enrollment
3. Hospitalization for heart failure within the 30 days prior to enrollment
4. 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
5. Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
6. 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
7. Patients who are volume depleted based upon physical examination at the time of screening or randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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263 participants in 2 patient groups, including a placebo group

Dapagliflozin

Active Comparator group

Description:

Dapagliflozin 10 mg daily

Treatment:

Drug: Dapagliflozin

Dapagliflozin matching placebo

Placebo Comparator group

Description:

Dapagliflozin matching placebo 10 mg daily

Treatment:

Drug: Dapagliflozin matching placebo