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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 : Active, not recruiting
First Posted : January 12, 2016
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Saint Luke's Health System

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.

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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 : May 31, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. Difference in mean NTproBNP between the treatment and placebo study arms at 6 and 12 weeks. [ Time Frame: Baseline to Week 12 ]
    Difference in mean NTproBNP between the treatment and placebo study arms at 6 and 12 weeks.

  2. Proportion of patients that achieve a ≥ 5pts increase in heart failure disease specific quality of life (assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score) or a ≥ 20% decrease in NTproBNP over 12 weeks [ Time Frame: Baseline to Week 12 ]
    Proportion of patients that achieve a ≥ 5pts increase in heart failure disease specific quality of life (assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score) or a ≥ 20% decrease in NTproBNP over 12 weeks


Secondary Outcome Measures :
  1. Proportion of patients with a ≥ 5pts increase in KCCQ [ Time Frame: Baseline to Week 12 ]
    Proportion of patients with a ≥ 5pts increase in KCCQ

  2. Proportion of patients with a ≥ 20% decrease in NTproBNP [ Time Frame: Baseline to Week 12 ]
    Proportion of patients with a ≥ 20% decrease in NTproBNP

  3. Proportion of patients with a ≥ 5pts increase in KCCQ and a ≥ 20% decrease in NTproBNP [ Time Frame: Baseline to Week 12 ]
    Proportion of patients with a ≥ 5pts increase in KCCQ and a ≥ 20% decrease in NTproBNP

  4. Change in KCCQ score over 12 weeks. [ Time Frame: Baseline to Week 12 ]
    Change in KCCQ score over 12 weeks.

  5. Change in 6 minute walk score over 12 weeks. [ Time Frame: Baseline to Week 12 ]
    Change in 6 minute walk score over 12 weeks.

  6. Change in BNP over 12 weeks. [ Time Frame: Baseline to Week 12 ]
    Change in BNP over 12 weeks.

  7. Change in HbA1c over 12 weeks. (evaluated separately in patients with and without type 2 diabetes) [ Time Frame: Baseline to Week 12 ]
    Change in HbA1c over 12 weeks. (evaluated separately in patients with and without type 2 diabetes)

  8. Change in weight over 12 weeks [ Time Frame: Baseline to Week 12 ]
    Change in weight over 12 weeks

  9. Change in systolic blood pressure over 12 weeks [ Time Frame: Baseline to Week 12 ]
    Change in systolic blood pressure over 12 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 NYHA Class II or Class III heart failure (LVEF≤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. BNP ≥100 pg/mL and/or 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 MI, non-ST-elevation MI, 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

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
Show Show 25 study locations
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

Additional Information:
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
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Saint Luke's Health System:
heart failure
dapagliflozin
SGLT-2 inhibitors
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs