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Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure (DAPA-HF)

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ClinicalTrials.gov Identifier: NCT03036124
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction

Condition or disease Intervention/treatment Phase
Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) Drug: Dapagliflozin Drug: Placebo Phase 3

Detailed Description:
This is an international, multicentre, parallel group, event-driven, randomized, double-blind, placebo-controlled study in patients with chronic heart failure with reduced ejection fraction (HFrEF), evaluating the effect of dapagliflozin versus placebo, given once daily in addition to background regional standard of care therapy, for the prevention of cardiovascular (CV) death or reduction of heart failure (HF) events.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4744 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : July 17, 2019
Actual Study Completion Date : July 17, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dapagliflozin
Patients will be randomized 1:1 to either dapagliflozin or placebo.
 Drug: Dapagliflozin
10 mg or 5 mg tablets given once daily, per oral use.
Other Names:
  • Forxiga TM
  • Farxiga TM
Placebo Comparator: Placebo
Placebo matching dapagliflozin.
 Drug: Placebo
Placebo matching dapagliflozin 10 mg or 5 mg.


Outcome Measures
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Primary Outcome Measures :
  1. Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. [ Time Frame: Up to 27.8 months. ]
    Primary efficacy


Secondary Outcome Measures :
  1. Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. [ Time Frame: Up to 27.8 months. ]
    Secondary

  2. Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death. [ Time Frame: Up to 27.8 months. ]
    Secondary

  3. Change From Baseline in the KCCQ Total Symptom Score [ Time Frame: Baseline and 8 months or death before 8 months ]
    KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

  4. Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death. [ Time Frame: Up to 27.8 months. ]
    Secondary

  5. Subjects Included in the Endpoint of All-cause Mortality. [ Time Frame: Up to 27.8 months. ]
    Secondary


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of signed informed consent prior to any study specific procedures
  • Male or female, aged ≥18 years
  • Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
  • LVEF≤40%
  • Elevated NT-proBNP levels
  • Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
  • eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)

Exclusion Criteria:

  • Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
  • Type 1 diabetes mellitus
  • Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
  • Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
  • MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
  • Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
  • Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
  • Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
  • HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
  • Symptomatic bradycardia or second or third degree heart block without a pacemaker
  • Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of 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): NCT03036124


Locations
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Sponsors and Collaborators
AstraZeneca
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] October 26, 2017
Statistical Analysis Plan  [PDF] July 23, 2019

More Information
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Additional Information:

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

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03036124    
Other Study ID Numbers: D1699C00001
2016-003897-41 ( EudraCT Number )
First Posted: January 30, 2017    Key Record Dates
Results First Posted: September 1, 2020
Last Update Posted: September 1, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
HFrEF
Heart Failure (HF)
Cardiovascular Events (CV)
Phase III outcome trial
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