DELIVER - Dapagliflozin Evaluation to Improve the LIVEs of Patients with PReserved Ejection Fraction Heart Failure An International Double-blind Randomised Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV D
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Congestive Heart Failure
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Age: Between 40 - 99 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Subjects must be older than 40 years old
- Subjects must have schemic symptoms (stable or unstable angina or NSTEMI without thrombosis of the target lesion on coronary angiography) or evidence of myocardial ischemia
- Subjects must have diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs2 of heart failure =6 weeks before enrolment with at least intermittent need for diuretic treatment.
- Subjects must complete and sign the written, informed consent
- Subjects must have Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease
- Subjects may be ambulatory, or hospitalized; patients must be off intravenous heart failure therapy
You may not be eligible for this study if the following are true:
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- Subjects receiving therapy with an SGLT2 inhibitor
- Subjects with Type 1 diabetes mellitus (T1D)
- Subjects with planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement
- Subjects who have stroke or transient ischemic attack (TIA) within 12 weeks prior
- Subjects who may have probable alternative or concomitant diagnoses which in the opinion of the investigator could account for the patient's HF symptoms and signs
- Subjects with primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD
- Subjects with previous cardiac transplantation, or complex congenital heart disease and may have planned cardiac resynchronisation therapy
- Subjects with HF due to any of the following: known infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular disease
- Subjects with a life expectancy of less than 2 years due to any non-cardiovascular condition
- Subjects who are unable to understand and/or comply with study medications, procedures and/or follow-up OR any conditions that may render the patient unable to complete the study
- Subjects with active malignancy requiring treatment
- Subjects with acute or chronic liver disease with severe impairment of liver function
- Female subjects of child-bearing potential not willing to use a medically accepted method of contraception considered reliable in the judgment of the investigator OR who have a positive pregnancy test at randomisation OR who are breast-feeding
- Subjects involved in the planning and/or conduct of the study
- Subjects who were previous randomized in the present study
- Subjects who participate in another clinical study with an IP or device during the last month prior to enrolment
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