Effects of metformin treatment on myocardial efficiency in patients with heart failure

Phase 1

• Conditions: MedDRA version: 19.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002767-42-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-14
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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 < 45%
- NYHA-class II, III or IV
- Relativley preserved renal function (eGFR > 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 < 7.0 mmol/l and 2 hour P-glucose 7.8 -11.0 mmol/l
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

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 < 3 months at the time of randomization
- Planned coronary revascularization
- Significant, uncorrected cardiac valve disease
- Cardiac arrest or life threatening ventricular arrhythmias within the last 3 months (unless treated with an ICD)
- Atrial fibrillation with poorly controlled ventricular rate at rest (> 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 < 18 years
- Current abuse of alcohol or drugs
- Cancer, with a life-expectancy of less than 2 years
- Stroke within the last 6 months
- Liver disease with P-ALAT >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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified