Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure
Purpose
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.
Condition
- Chronic Heart Failure With Reduced Systolic Function
Eligibility
- Eligible Ages
- Between 19 Years and 119 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 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
- 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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Dapagliflozin |
Dapagliflozin 10 mg daily |
|
|
Placebo Comparator Dapagliflozin matching placebo |
Dapagliflozin matching placebo 10 mg daily |
|
More Details
- Status
- Completed
- Sponsor
- Saint Luke's Health System
Study Contact
Detailed 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.