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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02653482
Recruitment Status : Completed
First Posted : January 12, 2016
Results First Posted : December 1, 2021
Last Update Posted : April 21, 2022
Sponsor:
Information provided by (Responsible Party):
Saint Luke's Health System

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure With Reduced Systolic Function Drug: Dapagliflozin Drug: Dapagliflozin matching placebo Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure
Actual Study Start Date : March 3, 2016
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dapagliflozin
Dapagliflozin 10 mg daily
 Drug: Dapagliflozin
Other Name: Farxiga
Placebo Comparator: Dapagliflozin matching placebo
Dapagliflozin matching placebo 10 mg daily
 Drug: Dapagliflozin matching placebo
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 119 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653482


Locations
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Sponsors and Collaborators
Saint Luke's Health System
Investigators
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Study Chair: Mikhail Kosiborod, MD Saint Luke's Mid America Heart Institute
  Study Documents (Full-Text)

Documents provided by Saint Luke's Health System:
Study Protocol  [PDF] November 4, 2017
Statistical Analysis Plan  [PDF] June 26, 2019

More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Saint Luke's Health System
ClinicalTrials.gov Identifier: NCT02653482    
Other Study ID Numbers: D1690C00032
First Posted: January 12, 2016    Key Record Dates
Results First Posted: December 1, 2021
Last Update Posted: April 21, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Saint Luke's Health System:
heart failure
dapagliflozin
Sodium-glucose co-transporter-2 (SGLT-2) inhibitors
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Dapagliflozin
 Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs