MedDRA version: 19.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849
Conditions
Interventions
Product Name: Glucophage XR
Product Code: EMD 89502
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Metformin hydrochloride
Other descriptive name: METFORMIN HYDROCHLORIDE
Concentrat
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with chronic heart failure 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 should be implanted, if indicated. Patients with a CRT device should be treated for > 3 months. - LVEF 30 ml/min) - Ability to understand the written patient information and to give informed consent. - Negative urine-HCG for women of childbearing potential - Patients must have insulin resistance, defined as 1 or more of the following criteria: - HbA1c 5.5 - 6.4% (37 - 47 mmol/mol) within the last 12 months prior to enrolment - Impaired fasting glucose (IFG): Fasting P-glucose 5.6 – 6.9 mmol/l within 12 months prior to enrolment (patient in stable condition) - Impaired glucose tolerance (IGT) if OGTT has been performed at any time prior to enrolment: Fasting P-glucose =65 years) yes F.1.3.1 Number of subjects for this age range 21
Exclusion criteria
Exclusion criteria: - Metformin treatment within the last 3 months - Known allergy to metformin or major side effects to metformin treatment - Acute myocardial infarction, unstable angina or revascularization 100 beats/min) - Hypertrophic or restrictive cardiomyopathy, infiltrative or storage myocardial disease, active myocarditis, or pericardial disease. - Listed for heart transplantation or expected to be so during the next year. - 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) - Age 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 - Participation in another study involving long-term medical intervention (participation in device studies is allowed)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate in a randomized, double-blinded placebo-controlled design if metformin treatment in patients with heart failure has beneficial effects on left ventricular myocardial oxidative metabolism, efficiency, contractile function and physical performance.;Secondary Objective: Not applicable;Primary end point(s): Myocardial efficiency;Timepoint(s) of evaluation of this end point: After 3 months of metformin treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Left ventricular global longitudinal strain during peak exercise Myocardial oxygen consumption Myocardial perfusion at rest LV myocardial function evaluated by LVEF and diastolic function LV mass 6 minute walking distance Maximum oxygen consumption evaluated by CPX-test Insulin resistance Minnesota living with heart failure questionnaire NT-proBNP;Timepoint(s) of evaluation of this end point: After 3 months of metformin treatment | — |
Countries
Denmark
Contacts
Public ContactHenrik Wiggers
Aarhus University Hospital
Outcome results
None listed