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:

  • Conditions:
    Congestive Heart Failure
  • Age: Between 40 - 99 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects must be older than 40 years old
    2. 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
    3. 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.
    4. Subjects must complete and sign the written, informed consent
    5. Subjects must have Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease
    6. 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:

    1. Subjects receiving therapy with an SGLT2 inhibitor
    2. Subjects with Type 1 diabetes mellitus (T1D)
    3. Subjects with planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement
    4. Subjects who have stroke or transient ischemic attack (TIA) within 12 weeks prior
    5. 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
    6. Subjects with primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD
    7. Subjects with previous cardiac transplantation, or complex congenital heart disease and may have planned cardiac resynchronisation therapy
    8. 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
    9. Subjects with a life expectancy of less than 2 years due to any non-cardiovascular condition
    10. 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
    11. Subjects with active malignancy requiring treatment
    12. Subjects with acute or chronic liver disease with severe impairment of liver function
    13. 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
    14. Subjects involved in the planning and/or conduct of the study
    15. Subjects who were previous randomized in the present study
    16. Subjects who participate in another clinical study with an IP or device during the last month prior to enrolment



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