NCT02810132

Effects of Metformin Treatment on Myocardial Efficiency in Patients With Heart Failure

Effects of Metformin Treatment on Myocardial Efficiency in Patients With Heart Failure: A Randomized, Double-blind, Placebo-controlled Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure, Systolic

Interventions

Type	Name	Description
DRUG	Metformin	See above
DRUG	Placebo	See above

Timeline

• Start date: 2017-01-20
• Primary completion: 2018-02-14
• Completion: 2018-02-14
• First posted: 2016-06-22
• Last updated: 2018-04-20

Locations

1 site across 1 country: Denmark