Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT02810132
Eligibility 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 \< 45%
* NYHA-class II, III or IV
* Relatively 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:
1. HbA1c 5.5 - 6.4% (37 - 47 mmol/mol) within the last 12 months prior to enrolment
2. Impaired fasting glucose (IFG): Fasting P-glucose 5.6 - 6.9 mmol/l within 12 months prior to enrolment (patient in stable condition)
3. 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
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.
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02810132
Study Brief:
Protocol Section:
NCT02810132