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
- Conditions
- Heart failurepreserved ejection fraction10019280
- Registration Number
- NL-OMON49973
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
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
enrolment.
7. Planned coronary revascularization, ablation of atrial flutter/fibrillation
and valve
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time to (first occurrence of):<br /><br><br /><br>1. CV death.<br /><br><br /><br>2. Hospitalisation for HF.<br /><br><br /><br>3. Urgent HF visit (e.g., emergency department or outpatient visit).</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Total number of (first and recurrent) hospitalisations for HF and CV death.<br /><br><br /><br>2. Change from baseline in the total symptom score (TSS) of the KCCQ at 8<br /><br>months.<br /><br><br /><br>3. Time to the occurrence of CV death<br /><br><br /><br>4. Time to the occurrence of death from any cause.</p><br>