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 Fractio
- Conditions
- Hartfailurereduced ejection fraction10019280
- Registration Number
- NL-OMON45523
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Provision of signed informed consent prior to any study specific procedures
2. Male or female, aged *18 years at the time of consent
3. Established documented diagnosis of symptomatic HFrEF
4. LVEF*40% within the last 12 months prior to enrolment (Visit 1)
5. NT-proBNP >600 pg/ml
6. Patients should receive background standard of care for HFrEF
7. eGFR *30 ml/min/1.73 m2 at visit 1
1. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
2. Type 1 diabetes mellitus (T1D)
3. Symptomatic hypotension or systolic BP <95 mmHg on 2 consecutive measurements
4. Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
5. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
6. Coronary revascularization 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
7. Implantation of a cardiac CRT within 12 weeks prior to enrolment or intent to implant a CRT device
8. Previous cardiac transplantation or implantation of a ventricular assistance device
(VAD) or similar device, or implantation expected after randomization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main objective of the study is to investigate whether dapagliflozin,<br /><br>compared with placebo, reduces the incidence of CV death or hospitalization for<br /><br>HF or equivalent event (ie an urgent HF visit) when added to background<br /><br>standard of care treatment.</p><br>
- Secondary Outcome Measures
Name Time Method