Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

In brief

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

Key facts

Study ID: NCT03036124
Run by: AstraZeneca
People needed: 4744
Starts: 2017-02-08
Expected to finish: 2019-07-17
Last updated by the study team: 2020-09-01

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Research Site — Mobile, Alabama, United States
Research Site — Sheffield, Alabama, United States
Research Site — Bakersfield, California, United States
Research Site — Beverly Hills, California, United States
Research Site — Los Angeles, California, United States
Research Site — Palm Springs, California, United States
Research Site — Stockton, California, United States
Research Site — Torrance, California, United States
Research Site — Vista, California, United States
Research Site — Wilmington, Delaware, United States
Research Site — Boynton Beach, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Lake Worth, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Naples, Florida, United States
Research Site — New Smyrna Beach, Florida, United States
Research Site — Pembroke Pines, Florida, United States
Research Site — Port Charlotte, Florida, United States
Research Site — Saint Augustine, Florida, United States
Research Site — Wellington, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Cumming, Georgia, United States
Research Site — Fairhope, Alabama, United States

Full record on ClinicalTrials.gov

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