Clinical trial

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

Name

RSPL1.5

Description

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.

Trial arms

Trial start

2023-10-01

Estimated PCD

2024-10-10

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Metformin

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)

Arms:

intervention (metformin)

Size

Primary endpoint

The change in the mean early diastolic mitral annular velocity (mean e'), at 3 and 6 months

baseline, 3 and 6 months

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective open-label, randomized controlled study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2023-10-11

1 organization

1 drug

2 indications

Organization

Sara Eladawy

Drug

Metformin

Indication

Diastolic Dysfunction

Indication

Obesity