Effects of Metformin Treatment on Myocardial Efficiency in Patients With Heart Failure (METRONOME)
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|ClinicalTrials.gov Identifier: NCT02810132|
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : April 20, 2018
The study evaluates the effects of metformin treatment on myocardial efficiency in heart failure patients. 36 patients will be randomized to three months of metformin or placebo treatment in addition to their regular therapy.
Hypothesis: Treatment with metformin in patients with heart failure has direct or indirect beneficial effects on left ventricular myocardial oxidative metabolism, myocardial efficiency and contractile function.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Systolic||Drug: Metformin Drug: Placebo||Phase 2|
Background: Heart failure (HF) is a common disease and diabetes/insulin resistance are present in approximately 50 % of HF patients. Metformin is the most commonly prescribed oral anti-diabetic drug, and registry and experimental studies show beneficial effects of metformin in HF, but randomized trials are needed.
Objectives: To investigate if treatment with metformin in patients with HF has beneficial effects on myocardial efficiency,
Design: A randomized, double-blind, placebo-controlled, single-center design. 36 patients with systolic heart failure will be randomized to either metformin (N = 18) or placebo (N= 18) for 3 months.
Methods: Patients will undergo echocardiography at rest and during exercise along with [11C]-acetate PET.
Primary outcome parameter is changes in myocardial external efficiency from visit 1 to 3 months of therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effects of Metformin Treatment on Myocardial Efficiency in Patients With Heart Failure: A Randomized, Double-blind, Placebo-controlled Study|
|Actual Study Start Date :||January 20, 2017|
|Actual Primary Completion Date :||February 14, 2018|
|Actual Study Completion Date :||February 14, 2018|
Active Comparator: Metformin
Drug: Metformin Target dose: 1000 mg x 2 (if eGFR 30-60 ml/min: 500 mg x 2) Other name: Glucophage XR 500
Other Name: Glucophage XR 500
Placebo Comparator: Placebo
- Changes in LV myocardial efficiency [ Time Frame: Baseline and 3 months ]LV myocardial efficiency is the ratio between stroke work and myocardial oxygen consumption, which are measured with echocardiography and [11C]-acetate PET.
- Left ventricular global longitudinal strain during peak exercise [ Time Frame: Baseline and 3 months ]
- Myocardial oxygen consumption [ Time Frame: Baseline and 3 months ]
- Myocardial perfusion at rest [ Time Frame: Baseline and 3 months ]
- LV myocardial function evaluated by LVEF and diastolic function [ Time Frame: Baseline and 3 months ]
- LV mass [ Time Frame: Baseline and 3 months ]
- 6 minute walking distance [ Time Frame: Baseline and 3 months ]
- Changes in body composition [ Time Frame: Baseline and 3 months ]Measured by bioelectrical impedance analysis (BIA)
- Maximum oxygen consumption [ Time Frame: Baseline and 3 months ]
- Degree of insulin resistance [ Time Frame: Baseline and 3 months ]
- Minnesota living with heart failure questionnaire [ Time Frame: Baseline and 3 months ]
- NT-proBNP [ Time Frame: Baseline and 3 months ]
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): NCT02810132
|Aarhus University Hospital, Department of Cardiology, Palle Juul-Jensens Boulevard 99|
|Aarhus N, Denmark, 8200|