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 - DAPAGLIFLOZIN EVALUATION TO IMPROVE THE LIVES OF PATIENTS WITH PRESERVED EJECTION FRACTION HEART FAILURE
- Conditions
- -I50I50
- Registration Number
- PER-026-18
- Lead Sponsor
- AstraZeneca AB,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 241
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 (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.
4.Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.
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) for at least 12 hours prior to enrolment and 24 hours prior to randomisation.
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 at 5-minute intervals, at Visit 1 or at Visit 2
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 at 5-minute intervals, at Visit 1 or at Visit 2.
6.MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.
For additiona information please refer to the protocol´s page 28 and 29
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Time to the first occurrence of any of the components of this composite:<br>1.CV death<br>2.Hospitalisation for HF<br>3.Urgent HF visit (e.g., emergency<br>department or outpatient visit)<br><br>Measure:To determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the composite of CV death and HF events (hospitalisation for HF or urgent HF visit) in patients with HF and preserved systolic function.<br>Timepoints:Since patient´s randomization till event<br>
- Secondary Outcome Measures
Name Time Method