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Completed

NCT Number: NCT02653482

Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure

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.

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Key information

Conditions

Chronic Heart Failure With Reduced Systolic Function Cardiovascular Diseases Heart Diseases Heart Failure

Age range

19 year–119 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Heart Group of the Eastern Shore, Fairhope, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

Drug

Other names: Farxiga

Dapagliflozin matching Placebo

Drug

Other names: Placebo

Primary outcomes

  1. 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).

  2. 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

  1. Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)

    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) 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.

  2. Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)

    Time frame: Baseline to Week 6 and Week 12

    Percentage of patients with a ≥ 20% decrease in NTproBNP as measured at Week 6 and Week 12.

  3. 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)

    Time frame: Average of 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.

  4. Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks.

    Time frame: Baseline to Week 6 and Week 12

    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.

  5. Change in 6 Minute Walk Score Over 12 Weeks.

    Time frame: Baseline to Week 6 and Week 12

    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.

  6. Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks.

    Time frame: Baseline to Week 6 and Week 12

    Change in BNP over 12 weeks as measured at Week 6 and Week 12 as measured at Week 6 and Week 12.

  7. Change in Hemoglobin A1c (HbA1c) Over 12 Weeks.

    Time frame: Baseline to Week 6 and Week 12

    Change in HbA1c over 12 weeks as measured at Week 6 and Week 12.

  8. Change in Weight Over 12 Weeks

    Time frame: Baseline to Week 6 and Week 12

    Change in weight over 12 weeks as measured at Week 6 and Week 12.

  9. Change in Systolic Blood Pressure Over 12 Weeks

    Time frame: Baseline to Week 6 and Week 12

    Change in systolic blood pressure over 12 weeks as measured at Week 6 and Week 12.

Sponsors and collaborators

Lead sponsor

Saint Luke's Health System

Other

Registry information

Acronym: DEFINE-HF

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 12, 2016
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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