Metformin in Heart Failure Without Diabetes (Met-HeFT)

Columbia University

Status and phase

Terminated

Phase 2

Conditions

Heart Failure

Treatments

Drug: Placebo

Drug: Metformin hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT03331861

AAAR5389

Details and patient eligibility

About

A pilot clinical research study that will assess the use of the medication metformin for heart failure in patients who are not diabetic and have no evidence of insulin resistance.

Full description

Patients (n=50) will received either the study drug metformin or placebo for 4 months. During the study, the patients will undergo extensive testing that will include symptom assessment, exercise capacity, echocardiography, cardiac PET imaging and blood tests.

Enrollment

6 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >18yrs old
Patients with chronic heart failure (defined as >6 months duration) uptitrated to 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). An ICD and/or CRT should be implanted, if indicated. Patients with a CRT device should be treated for > 3 months.
Reduced ejection fraction defined as LVEF ≤ 35%
NYHA-class II or III with stable symptoms for at least the past 3 months
Renal Function by eGFR ≥ 45 ml/min (MDRD equation) in accordance with FDA guidance on metformin use in CKD(24)
Non-insulin resistant defined as a fasting insulin resistance index, or HOMA-IR of <2.7.
Non-diabetic defined as a HgbA1c <6.0

Exclusion criteria

Any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas)
Known allergy to metformin or major side effects to metformin treatment
Concomitant use of a carbonic anhydrase inhibitor (such as acetazolamide or topirafmate)
Heart Failure Hospitalizations in the past 3 months (primary diagnosis on admission is heart failure)
Acute myocardial infarction, unstable angina or revascularization with prior 3 months at the time of randomization
Planned coronary revascularization, heart surgery, CRT implantation or other intervention during the study period that would potentially affect the function of the heart
Significant, uncorrected primary cardiac valve disease, specifically severely stenotic or regurgitant mitral or aortic valves
Cardiac arrest or life threatening ventricular arrhythmias within the last 3 months (unless treated with an ICD)
Atrial fibrillation with poorly controlled ventricular rate at rest (> 110 beats/min)
Hypertrophic or restrictive cardiomyopathy, infiltrative or storage myocardial disease, active myocarditis, or pericardial disease.
Planned major surgery within the study period
Female patients who are pregnant, nursing, or of childbearing potential while not practicing effective chemical contraceptive methods (i.e. oral, implanted, injectable, or transdermal contraceptive hormones; intrauterine device)
Current abuse of alcohol or drugs
Life-expectancy of less than 1 year due to co-existing morbid illness
Liver disease with ALT or AST >3 times upper normal limit (it is possible to repeat this measurement once within a month)
Advanced lung disease such as COPD
Significant comorbidity or issue that makes the patient unsuitable for participation as judged by the investigator
Participation in another study involving long-term medical intervention (participation in device studies is allowed)