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Search / Trial NCT05847244

The Effect of Addition of Metformin In Obese Non- Diabetic Patients With Heart Failure With Preserved Ejection Fraction

Launched by SARA ELADAWY · Apr 26, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Metformin Obesity Diastolic Dysfunction

ClinConnect Summary

This clinical trial is studying the effects of adding a medication called metformin to the treatment of obese patients who have heart failure with preserved ejection fraction (HFpEF). Heart failure with preserved ejection fraction means the heart can pump blood normally, but it doesn't fill with enough blood, which can cause symptoms like fatigue and shortness of breath. Researchers want to see if metformin, a drug typically used to manage blood sugar levels in diabetes, can help improve outcomes for these patients, especially since obesity and heart failure are closely linked and can lead to more serious health issues.

To participate in this trial, potential candidates should be between 40 and 74 years old, have a body mass index (BMI) of 30 or higher (which indicates obesity), and be experiencing moderate to severe heart failure symptoms. Participants will be asked to provide their written consent and will be monitored throughout the study. It’s important to note that certain individuals, such as those with different types of heart failure or specific health conditions, won't be eligible for this trial. Overall, this study aims to find out if metformin can help improve heart health in a group of patients who currently have limited treatment options.

Gender

ALL

Eligibility 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

About Sara Eladawy

Sara Eladawy is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With extensive experience in overseeing and managing clinical trials, Sara focuses on innovative therapeutic areas and collaborates closely with healthcare professionals and research institutions. Her expertise in regulatory compliance and patient safety ensures that all trials are conducted with the highest ethical standards and scientific rigor. By fostering partnerships and promoting rigorous methodologies, Sara Eladawy aims to contribute to the development of groundbreaking treatments that address unmet medical needs.

Locations

Cairo, , Egypt

Cairo, , Egypt

Patients applied

0 patients applied

Trial Officials

sara Eladawy, PhD

Study Director

MSa university

Naglaa Bazan, Ass. Prof

Principal Investigator

Cairo University Hospitals

shreen Elgengeehy, Prof.

Study Chair

Cairo University Hospitals

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported