EUCTR2016-003897-41-DK
Active, Not Recruiting
Phase 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
ConditionsChronic Heart Failure (HF) with Reduced Ejection FractionMedDRA version: 20.0 Level: PT Classification code 10007558 Term: Cardiac failure chronic System Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsForxiga
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Heart Failure (HF) with Reduced Ejection Fraction
- Sponsor
- AstraZeneca AB
- Enrollment
- 4500
- Status
- Active, Not Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
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:
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
Outcomes
Primary Outcomes
Not specified
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