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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 : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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 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
Estimated Primary Completion Date : December 4, 2019
Estimated Study Completion Date : December 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.




Primary Outcome Measures :
  1. 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 approximately 3 years ]

Secondary Outcome Measures :
  1. 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 approximately 3 years ]
  2. Total number of (first and recurrent) HF hospitalizations and CV death. [ Time Frame: From randomization visit (day 0) up to approximately 3 years ]
  3. Change from baseline measured at 8 months in the total symptom score of the Kansas City Cardiomyopathy Questionnaire (KCCQ), a specific HF patient reported outcome questionnaire. [ Time Frame: From randomization visit (day 0) up to 8 months (day 240) ]
  4. 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 approximately 3 years ]

    End Stage Renal Disease (ESRD) is defined as;

    • Sustained eGFR <15 mL/min/1.73m^2 or,
    • Chronic dialysis treatment or,
    • Receiving a renal transplant

  5. Time to death from any cause. [ Time Frame: From randomization visit (day 0) up to approximately 3 years ]


Information from the National Library of Medicine

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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

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


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Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03036124     History of Changes
Other Study ID Numbers: D1699C00001
2016-003897-41 ( EudraCT Number )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

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:
Heart Failure
Heart Diseases
Cardiovascular Diseases