Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Saint Luke's Health System
- Enrollment
- 263
- Locations
- 25
- Primary Endpoint
- Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP).
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 119 Years (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
Dapagliflozin
Dapagliflozin 10 mg daily
Intervention: Dapagliflozin (Drug)
Dapagliflozin matching placebo
Dapagliflozin matching placebo 10 mg daily
Intervention: Dapagliflozin matching placebo (Drug)
Outcomes
Primary Outcomes
Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP).
Time Frame: Average of Week 6 and Week 12
Difference in the average of the 6- and 12-week mean N-terminal pro B-type natriuretic peptide (NTproBNP).
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
Time Frame: Average of Week 6 and Week 12
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.
Secondary Outcomes
- Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)(Baseline to Week 6 and Week 12)
- Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks.(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)(Baseline to Week 6 and Week 12)
- Change in Weight Over 12 Weeks(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)(Average of Week 6 and Week 12)
- Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks.(Baseline to Week 6 and Week 12)
- Change in 6 Minute Walk Score Over 12 Weeks.(Baseline to Week 6 and Week 12)
- Change in Hemoglobin A1c (HbA1c) Over 12 Weeks.(Baseline to Week 6 and Week 12)
- Change in Systolic Blood Pressure Over 12 Weeks(Baseline to Week 6 and Week 12)