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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.


Detailed Summary:

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.


Sponsor: Aarhus University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Changes in LV myocardial efficiency [ Time Frame: 3 months ]

LV myocardial efficiency is the ratio between stroke work and myocardial oxygen consumption, which are measured with echocardiography and [11C]-acetate PET.


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Left ventricular global longitudinal strain during peak exercise [ Time Frame: 3 months ]
  • Myocardial oxygen consumption [ Time Frame: 3 months ]
  • Myocardial perfusion at rest [ Time Frame: 3 months ]
  • LV myocardial function evaluated by LVEF and diastolic function [ Time Frame: 3 months ]
  • LV mass [ Time Frame: 3 months ]
  • 6 minute walking distance [ Time Frame: 3 months ]
  • Changes in body composition [ Time Frame: 3 months ]
    Measured by bioelectrical impedance analysis (BIA)
  • Maximum oxygen consumption [ Time Frame: 3 months ]
  • Degree of insulin resistance [ Time Frame: 3 months ]
  • Minnesota living with heart failure questionnaire [ Time Frame: 3 months ]
  • NT-proBNP [ Time Frame: 3 months ]


Information By: Aarhus University Hospital

Dates:
Date Received: June 8, 2016
Date Started: January 20, 2017
Date Completion: December 2018
Last Updated: March 23, 2017
Last Verified: March 2017