NL-OMON45523
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 - DAPA HF
Astra Zeneca0 sites100 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hartfailure
- Sponsor
- Astra Zeneca
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, Not Recruiting
Phase 1
Study to evaluate if dapagliflozin treatment is effective in patients with heart failure by reducing the number of hospitalizations and urgent visits due to heart failure, and by reducing the risk of death.Chronic Heart Failure (HF) with Reduced Ejection FractionTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2016-003897-41-PLAstraZeneca AB4,500
Active, Not Recruiting
Phase 1
Study to evaluate if dapagliflozin treatment is effective in patients with heart failure by reducing the number of hospitalizations and urgent visits due to heart failure, and by reducing the risk of death.Chronic 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]EUCTR2016-003897-41-DKAstraZeneca AB4,500
Active, Not Recruiting
Phase 1
Study to evaluate if dapagliflozin treatment is effective in patients with heart failure by reducing the number of hospitalizations and urgent visits due to heart failure, and by reducing the risk of death.Chronic Heart Failure (HF) with Reduced Ejection FractionTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2016-003897-41-BGAstraZeneca AB4,500
Active, Not Recruiting
Phase 1
Study to evaluate if dapagliflozin treatment is effective in patients with heart failure by reducing the number of hospitalizations and urgent visits due to heart failure, and by reducing the risk of death.EUCTR2016-003897-41-SEAstraZeneca AB4,500
Completed
Phase 3
DAPA-HFChronic Heart Failure With Reduced Ejection Fraction (HFrEF)JPRN-jRCT2080223469AstraZeneca KK330