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Metformin in Heart Failure Without Diabetes (Met-HeFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331861
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Barry Fine, Columbia University

Brief Summary:

Columbia University Medical Center is conducting 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.

Patients 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 assesment, exercise capacity, echocardiography, cardiac PET imaging and blood tests.


Condition or disease Intervention/treatment Phase
Heart Failure Drug: Metformin hydrochloride Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metformin in Heart Failure Without Diabetes
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Metformin
Metformin for 6 months
Drug: Metformin hydrochloride
Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months

Placebo Comparator: Placebo
Matched placebo for 6 months
Drug: Placebo
Similar dosing regime as active comparator




Primary Outcome Measures :
  1. Change in Minute Ventilation to Carbon Dioxide Production (VE/VCO2) Slope [ Time Frame: Baseline and 6 months ]

Secondary Outcome Measures :
  1. Change in Dyspnea Assesment Score [ Time Frame: Baseline and 6 months ]
    100mm Visual Analog Scale. 100mm line scale ranging from 0 (worse imaginable breathing) to 100 (best imaginable breathing)

  2. Minnesota Health Living with Heart Failure Questionnaire [ Time Frame: Baseline and 6 months ]
    Score

  3. Left Ventricular Function Evaluated by Ejection Fraction and Diastolic Function on Echocardiography [ Time Frame: Baseline and 6 months ]
  4. Global Longitudinal Strain and Strain Rate Measured on Echocardiography [ Time Frame: Baseline and 6 months ]
  5. B Type Natriuretic Peptide (BNP) level [ Time Frame: Baseline and 6 months ]
  6. Body Weight [ Time Frame: Baseline and 6 months ]
    kg

  7. Peak Myocardial Oxygen Consumption (VO2) [ Time Frame: Baseline and 6 months ]
  8. Quantitative 18F-FDG Activity in 9 Myocardial Segments [ Time Frame: Baseline and 6 months ]
    Glucose Metabolism

  9. Quantitative N13-NH3 Activity in 9 Myocardial Segments [ Time Frame: Baseline and 6 months ]
    Perfusion

  10. Heart Failure Hospitalizations [ Time Frame: Over 6 months ]
    number


Other Outcome Measures:
  1. Hemoglobin A1c [ Time Frame: Baseline and 6 months ]
  2. Serum Lactate [ Time Frame: 1 month and 6 months ]
  3. Fasting Sugar [ Time Frame: 1 month and 6 months ]
    mg/dl



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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-D should be implanted, if indicated. Patients with a CRT device should be treated for > 3 months.
  • Reduced ejection fraction defined as LVEF < 40%
  • 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
  • Ability to understand the written patient information and to give informed consent
  • Negative urine-HCG for women of childbearing potential

Exclusion Criteria:

  • Patients with diabetes or insulin resistant, defined as 1 or more of the following criteria:

    1. HbA1c >6.0% within the last 12 months prior to enrollment
    2. Impaired fasting insulin resistance index (HOMA-IR) >2.7
  • Any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas)
  • Recent Hospitalizations in the past 3 months
  • Metformin treatment within the last 3 months
  • eGFR below 45 in the prior 6 months
  • Known allergy to metformin or major side effects to metformin treatment
  • Acute myocardial infarction, unstable angina or revascularization < 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 cardiac valve disease
  • 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 (> 100 beats/min)
  • Hypertrophic or restrictive cardiomyopathy, infiltrative or storage myocardial disease, active myocarditis, or pericardial disease.
  • Planned major surgery
  • 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
  • Stroke within the last 6 months
  • Liver disease with P-ALAT >3 times upper normal limit (it is possible to repeat this measurement once within a month)
  • Significant comorbidity or issue that makes the patient unsuitable for participation as judged by the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331861


Contacts
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Contact: Barry Fine, MD 212-305-5755 bmf2002@cumc.columbia.edu

Locations
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United States, New York
New York Hospital - Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Andrea Kim    212-305-1368      
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Barry Fine, MD Columbia University
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Responsible Party: Barry Fine, Assistant Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03331861    
Other Study ID Numbers: AAAR5389
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs