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TERMINATEDPHASE2

Metformin in Heart Failure Without Diabetes

NCT03331861•Columbia University

Summary

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.

Detailed 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.

Eligibility

Age

18 - 80 years

Sex

ALL

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.
+8 more criteria

Locations (1)

New York Hospital - Columbia University Irving Medical Center

New York, New York, United States

Key Dates

Start Date

February 15, 2019

Primary Completion Date

August 20, 2021

Completion Date

August 20, 2021

Last Updated

July 18, 2024

Enrollment

ACTUAL participants

Conditions

Heart Failure

Interventions

Metformin hydrochloride

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Metformin in Heart Failure Without Diabetes

Inclusion Criteria

Exclusion Criteria

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