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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)

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: 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

Tracking Information
First Submitted Date  ICMJE January 26, 2017
First Posted Date  ICMJE January 30, 2017
Results First Submitted Date  ICMJE July 6, 2020
Results First Posted Date  ICMJE September 1, 2020
Last Update Posted Date September 1, 2020
Actual Study Start Date  ICMJE February 8, 2017
Actual Primary Completion Date July 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2020)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)		 Time to the first occurrence of any of the components of the composite: CV death or hospitalization for HF or an urgent HF visit. [ Time Frame: From randomization visit (day 0) up to approximatley 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2020)
  • Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. [ Time Frame: Up to 27.8 months. ]
    Secondary
  • Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death. [ Time Frame: Up to 27.8 months. ]
    Secondary
  • 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.
  • Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death. [ Time Frame: Up to 27.8 months. ]
    Secondary
  • Subjects Included in the Endpoint of All-cause Mortality. [ Time Frame: Up to 27.8 months. ]
    Secondary
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Time to the first occurrence of either of the components of the composite: CV death or hospitalization for HF. [ Time Frame: From randomization visit (day 0) up to approximatley 3 years ]
  • Total number of (first and recurrent) HF hospitalizations and CV death. [ Time Frame: From randomization visit (day 0) up to approximatley 3 years ]
  • Change from baseline measured at 8 months in the clinical summary score of the KCCQ, a specific HF patient reported outcome questionnaire. [ Time Frame: From randomization visit (day 0) up to 8 months (day 240) ]
  • Time to the first occurrence of any of the components of the composite: ≥50% sustained decline in eGFR or reaching End Stage Renal Disease (ESRD) or renal death. [ Time Frame: From randomization visit (day 0) up to approximatley 3 years ]
    End Stage Renal Disease (ESRD) is defined as;
    • Sustained eGFR <15 ml/min/1.73m2 or,
    • Chronic dialysis treatment or,
    • Receiving a renal transplant
  • Time to death from any cause. [ Time Frame: From randomization visit (day 0) up to approximatley 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Intervention  ICMJE
  • Drug: Dapagliflozin
    10 mg or 5 mg tablets given once daily, per oral use.
    Other Names:
    • Forxiga TM
    • Farxiga TM
  • Drug: Placebo
    Placebo matching dapagliflozin 10 mg or 5 mg.
Study Arms  ICMJE
  • Experimental: Dapagliflozin
    Patients will be randomized 1:1 to either dapagliflozin or placebo.
    Intervention: Drug: Dapagliflozin
  • Placebo Comparator: Placebo
    Placebo matching dapagliflozin.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2018)		 4744
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)		 4500
Actual Study Completion Date  ICMJE July 17, 2019
Actual Primary Completion Date July 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Bulgaria,   Canada,   China,   Czechia,   Denmark,   Germany,   Hungary,   India,   Japan,   Netherlands,   Poland,   Russian Federation,   Slovakia,   Sweden,   Taiwan,   United Kingdom,   United States,   Vietnam
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT03036124
Other Study ID Numbers  ICMJE D1699C00001
2016-003897-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP