EUCTR2016-003897-41-DKActive, not recruitingPhase 1
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 - DAPA HF
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 4,500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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 N-terminal pro b-type natriuretic peptide (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 m2 (CKD-EPI formula) at enrolment (visit 1)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2250
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
- •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
Investigators
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