Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-05 @ 6:31 PM
Study NCT ID:
NCT02810132
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Metformin Treatment on Myocardial Efficiency in Patients With Heart Failure
Sponsor:
Aarhus University Hospital
Organization:
Study Overview
Official Title:
Effects of Metformin Treatment on Myocardial Efficiency in Patients With Heart Failure: A Randomized, Double-blind, Placebo-controlled Study
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
METRONOME
Brief 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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: