The Effect of Addition of Metformin In Obese Non- Diabetic Patients With Heart Failure With Preserved Ejection Fraction
NCT05847244 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2023-10-11
Summary
Diabetes mellitus people have a higher incidence of cardiovascular disease, and the results of cardiovascular events are worse. Heart failure and diabetes both have a worse prognosis, with a 1.5-2 times increased risk of death. Data from the literature have shown that MET lowers mortality by 14-35% in this patient population, which represents one-third of all HF patients with no increases in lactic acidosis incidence.
Conditions
- Diastolic Dysfunction
- Obesity
Interventions
- DRUG
-
The intervention will consist in giving metformin starting with 500 mg once daily (at breakfast) during the first week; if well tolerated, the dose was progressively increased to 500 mg twice daily (at breakfast and dinner) during week 2, to 1000 mg at breakfast and 500 mg at dinner during week 3, in order to reach the target dose of 1000 mg twice daily (at breakfast and dinner)
Sponsors & Collaborators
-
Cairo University
collaborator OTHER -
Sara ElAdawy
lead OTHER
Principal Investigators
-
sara Eladawy, PhD · MSa university
-
Naglaa Bazan, Ass. Prof · Cairo University
-
shreen Elgengeehy, Prof. · Cairo University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 74 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-01
- Primary Completion
- 2024-10-10
- Completion
- 2024-12-01
Countries
- Egypt
Study Locations
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