EUCTR2015-002767-42-DK进行中（未招募）1 期
Effects of metformin treatment on myocardial efficiency in patients with heart failure: A randomized, double-blind, placebo-controlled study - METRONOME
Aarhus University Hospital0 个研究点目标入组 36 人开始时间: 2016年4月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •- 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)
研究者
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