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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
263
Heart Group of the Eastern Shore
Fairhope, Alabama, United States
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).
Time frame: 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.
Time frame: Average of Week 6 and Week 12
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.
Time frame: Baseline to Week 6 and Week 12
Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Southern Califiornia
Los Angeles, California, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Charlotte Heart Group Research Center
Port Charlotte, Florida, United States
Emory University
Atlanta, Georgia, United States
NorthShore University HealthSystem Research Institute
Evanston, Illinois, United States
Northwestern University
Evanston, Illinois, United States
Advocate Health and Hospitals
Oakbrook Terrace, Illinois, United States
University of Maryland
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
...and 15 more locations
Percentage of patients with a ≥ 20% decrease in NTproBNP as measured at Week 6 and Week 12.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 6 and Week 12