NL-OMON49973
Completed
Phase 3
An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients with Heart Failure with Preserved Ejection Fraction (HFpEF) - DELIVER study - DELIVER
Astra Zeneca0 sites160 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Astra Zeneca
- Enrollment
- 160
- 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 patients age \*40 years.
- •3\. Documented diagnosis of symptomatic heart failure HFpEF
- •4\. LVEF \>40%, measured within the last 12 months prior to enrolment and
- •evidence of structural heart disease.
- •5\. NT\-pro BNP \*300 pg/ml at Visit 1 for patients without ongoing atrial
- •fibrillation/flutter. If ongoing atrial fibrillation/flutter at Visit 1, NT\-pro
- •BNP must be
- •\*600 pg/mL.
- •6\. Patients may be ambulatory, or hospitalized; patients must be off
Exclusion Criteria
- •1\. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to
- •randomisation or
- •previous intolerance to an SGLT2 inhibitor
- •2\. Type 1 diabetes mellitus (T1D)
- •3\. eGFR \<25 mL/min/1\.73 m2 (CKD\-EPI formula) at Visit 1
- •4\. Systolic blood pressure (BP) \<95 mmHg on 2 consecutive measurements
- •5\. Systolic BP\*160 mmHg if not on treatment with \*3 blood pressure lowering
- •medications
- •or \*180 mmHg irrespective of treatments, on 2 consecutive measurements
- •6\. MI, unstable angina, coronary revascularization within 12 weeks prior to
Outcomes
Primary Outcomes
Not specified
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