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Summary

for people ages 18–130 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

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

Details

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.

Keywords

Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) HFrEF Heart Failure (HF) Cardiovascular Events (CV) Phase III outcome trial Heart Failure

Eligibility

You can join if…

Open to people ages 18–130

  • 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%
  • NT-proBNP ≥600 pg/ml
  • Patients should receive background standard of care for HFrEF
  • eGFR ≥30 ml/min/1.73 m2 (CKD-EPI formula) at enrolment (visit 1)

You CAN'T join 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
  • 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 cardiac 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 m2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization

Locations

  • Research Site not yet accepting patients
    San Francisco, California, 94143, United States
  • Research Site accepting new patients
    Bakersfield, California, 93309, United States
  • Research Site not yet accepting patients
    Beverly Hills, California, 90211, United States
  • Research Site not yet accepting patients
    Torrance, California, 90502, United States
  • Research Site accepting new patients
    Los Angeles, California, 90073, United States
  • Research Site accepting new patients
    Las Vegas, Nevada, 89148, United States
  • Research Site accepting new patients
    Palm Springs, California, 92262, United States
  • Research Site accepting new patients
    Oceanside, California, 92056-4510, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT03036124
Phase
Phase 3
Study Type
Interventional
Last Updated
October 18, 2017
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