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 个研究点目标入组 160 人开始时间: 待定最近更新: 2024年4月15日

研究概览

暂无简介。

•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
•intravenous heart
•failure therapy (including diuretics)

•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
•7. Planned coronary revascularization, ablation of atrial flutter/fibrillation
•repair/replacement.
•8. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
•9. Probable alternative or concomitant diagnoses which in the opinion of the
•investigator
•could account for the patient's HF symptoms and signs (e.g. anaemia,
•hypothyroidism)
•10. Body mass index >50 kg/m2
•11. Previous cardiac transplantation, or complex congenital heart disease.
•Planned cardiac
•resynchronisation therapy.

发起方

Astra Zeneca