JPRN-jRCT2080223469
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca KK
- Enrollment
- 330
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •Provision of signed informed consent prior to any study specific procedures
- •\- Established documented diagnosis of symptomatic HFrEF (NYHA functional class II\-IV), which has been present for at least 2 months
- •\- LVEF less than 40%
- •\- NT\-proBNP 600 pg/ml or more
- •\- Patients should receive background standard of care for HFrEF
- •\- eGFR 30 ml/min/1\.73 m2 (CKD\-EPI formula) or more 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
- •\- 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
Investigators
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