Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.

  • STATUS
    Recruiting
  • End date
    Nov 22, 2021
  • participants needed
    6100
  • sponsor
    AstraZeneca
Updated on 27 September 2020
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (1.9 mi away) Contact
+406 other location
diuretics
diuretic therapy
hypertrophy
ventricular hypertrophy

Summary

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.

Description

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind study in patients with HFpEF, 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 and heart failure events (hospitalisations for HF or urgent HF visits). Adult patients aged 40 years with HFpEF (LVEF >40% and evidence of structural heart disease) and New York Heart Association (NYHA) class II-IV who are eligible according to the inclusion/exclusion criteria will be randomised in a 1:1 ratio to receive either dapagliflozin 10 mg or placebo. Both out-patients and in-patients hospitalised for heart failure and off intravenous heart failure-therapy for 24 hours can be randomised. It is estimated that approximately 11000 patients at approximately 400-500 sites in 20-25 countries will need to be enrolled to reach the target of approximately 6100 randomised patients.

Details
Treatment Placebo, Dapagliflozin
Clinical Study IdentifierNCT03619213
SponsorAstraZeneca
Last Modified on27 September 2020

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Eligibility

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Inclusion Criteria

Is your age between 40 yrs and 130 yrs?
Gender: Male or Female
Do you have Heart Failure With Preserved Ejection Fraction?
Provision of signed informed consent prior to any study specific procedures
Male or female patients age 40 years
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
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
Elevated NT-pro BNP levels
Both ambulatory and hospitalised patients may be enrolled and randomised. Patients currently hospitalised for HF, must be off intravenous HF medications for at least 24 before randomisation
Further details regarding inclusion criteria 4-6 may apply

Exclusion Criteria

Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor
Type 1 diabetes mellitus (T1D)
eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1
Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2
Systolic BP160 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
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
Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement
Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
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)
Body mass index >50 kg/m2
Further exclusion criteria may apply
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