None listed
Conditions
Interventions
Control grup Type of group
This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.
Sponsors
AstraZeneca AB,
Eligibility
Inclusion 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 (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.
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Time to the first occurrence of any of the components of this composite: 1.CV death 2.Hospitalisation for HF 3.Urgent HF visit (e.g., emergency department or outpatient visit) 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. Timepoints:Since patient´s randomization till event | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Total number of (first and recurrent) hospitalisations for HF and CV death Measure:To determine whether dapagliflozin is superior to placebo in reducing the total number of recurrent HF hospitalisations and CV death Timepoints:SInce patient´s randomization toll end of the trial ; Outcome name:Change from baseline in the total symptom score (TSS) of the KCCQ at 8 months Measure:To determine whether dapagliflozin is superior to placebo in improving Patient Reported Outcomes measured by KCCQ Timepoints:SInce patient´s randomization toll end of the trial ; Outcome name:Proportion of patients with worsened NYHA class from baseline to 8 months Measure:To determine whether dapagliflozin is superior to placebo in reducing the proportion of patients with worsened NYHA class Timepoints:Since patient´s randomization toll end of the trial ; Outcome name:Time to the occurrence of death from any cause Measure:To determine whether dapagliflozin is superior to placebo in reducing all-cause mortality Timepoints:Since patient´s randomization till event registration | — |
Countries
Arabia Saudi, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, Hungary, Japan, Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, Taiwan, United States, Vietnam
Contacts
Public ContactGonzalo Ernesto Castro
ASTRAZENECA PERU S.A.
Outcome results
None listed