Efficacy of Metformin as add-on Therapy in Non-Diabetic Heart Failure Patients

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

There is an increasing interest in the use of metformin in CV diseases and there is an increasing interest in studying its potential new roles in heart failure patients. There were some concerns related to the safety of metformin in such diabetic patients due to the risk of lactic acidosis. However, recent studies showed that metformin was safe or even beneficial in HF patients. We hypothesized that metformin might improve morbidity, mortality, cardiac function, and HR-QoL in non-diabetic patients with HFrEF.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Chronic heart failure (>6 months duration)

• Stabilized on recommended or maximally tolerated dose of ACE-I/ARB (unless contraindicated) and beta-blocker (unless contraindicated). If indicated, an aldosterone receptor antagonist should be given (unless contraindicated).

• Reduced ejection fraction defined as LVEF < 40%

• NYHA-class II or III or IV with stable symptoms for at least the past 3 months

• Creatinine clearance > 45 ml/min

Exclusion Criteria:

• Diabetes mellitus: Diabetes will be diagnosed using the 2018 The American Diabetes Association (ADA) "Standards of Medical Care in Diabetes 15

• FPG ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.*

• 2-h PG ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water.

• A1C ≥6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.*

• In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L).

• Any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas)

• Recent Hospitalizations in the past 3 months

• Metformin treatment within the last 3 months

• Creatinine clearance below 45 in the prior 6 months as assessed by Cockcroft and Gault equation

• Known allergy to metformin or major side effects to metformin treatment

• Atrial fibrillation with poorly controlled ventricular rate at rest (> 100 beats/min)

• Hypertrophic cardiomyopathy