Using Metformin to Treat Obese Patients with Heart Failure and Normal Ejection Fraction
The Effect of Addition of Metformin In Obese Non- Diabetic Patients With Heart Failure With Preserved Ejection Fraction
This study is testing if adding metformin to the treatment plan can help obese patients with heart failure feel better and improve their heart health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 74 Years |
| Sex | All |
| Sponsor | October University for Modern Sciences and Arts Academic / other |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT05847244 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of adding metformin to the treatment regimen of obese, non-diabetic patients suffering from heart failure with preserved ejection fraction (HFpEF). The study aims to evaluate whether metformin can improve outcomes in this population, which is often complicated by obesity and other comorbidities. Participants will be aged between 40 and 74 years and will be monitored for changes in heart function and overall health. The trial is being conducted at Cairo University Hospital, focusing on a significant health issue prevalent in Egypt.
Who should consider this trial
Good fit: Ideal candidates for this study are obese, non-diabetic individuals aged 40 to 74 with heart failure and preserved ejection fraction.
Not a fit: Patients with heart failure and reduced ejection fraction, those under 40 or over 74, and individuals with diabetes or prior metformin use are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved heart function and reduced mortality rates in obese patients with HFpEF.
How similar studies have performed: While there is limited research specifically on metformin for HFpEF, existing studies suggest potential benefits of metformin in related cardiovascular conditions, indicating a promising but novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * - Inclusion criteria: * Age of 40 years to 74 years. * HFpEF (≥ 50%) * Written informed consent of the subject to participate in the study. * New York Heart Association functional class II-IV. * Body mass index ≥ 30 Kg/m2 Exclusion Criteria: * - Exclusion criteria: * Patients with heart failure with reduced ejection fraction (\< 40%) * Age less than 40 and more than 74 * New York Heart Association functional class I * Body mass index \< 30 Kg/m2 * Diabetic patients or prior metformin user * Renal impairment * Known allergy to metformin * End- stage liver disease * Cancer * Pregnancy or lactation
Where this trial is running
Cairo and 1 other locations
- Cairo University Hospitala — Cairo, Egypt (Recruiting)
- Cairo University Hospitals — Cairo, Egypt (Not_yet_recruiting)
Study contacts
- Principal investigator: Naglaa Bazan, Ass. Prof — Cairo University Hospitals
- Study coordinator: sara eladawy, PhD
- Email: smeladway@msa.edu.eg
- Phone: 01222124567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.