Socioeconomic Factors and Mechanisms of Sarcopenia and Muscle Strength in Chronic Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Physical performance, walking distance
研究概览
简要总结
The aim of the study is to provide information on the interaction between socioeconomic factors, daily physical activity, nutrition and lifestyle on loss of muscle mass and muscle function in patients with heart failure.
详细描述
A total of 200 consecutive heart failure patients will be included and 50 age and sex-matched individuals with no history of cardiovascular disease will serve as controls.
Baseline variables of body composition, physical capacity, daily physical activity, nutritional status, quality of life, socioeconomic status and insulin resistance will be obtained along with a skeletal muscle tissue biopsy and blood samples for laboratory analyses.
Baseline variables from heart failure patients will be compared to healthy controls.
Patients and controls will be invited to follow-up visits at 12 and 36 months. Changes in baseline variables will be analyzed.
Events will be identified through national registries.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide valid informed consent.
- •Heart failure with preserved, mid-range or reduced ejection fraction (NYHA I-IV) according to European Society of Cardiology guidelines.
排除标准
- •Cancer requiring treatment (e.g. prostate cancer on watchful waiting does not exclude patients).
- •Severe musculoskeletal or neurological disability.
- •Severe lung disease with a forced expiratory volume 1 < 40% of predicted. Treatment with anticoagulants (warfarin, apixaban, edoxaban, dabigatran and rivaroxaban) is an exclusion criterion for muscle biopsy. Patients with anticoagulant treatment will be invited to participate in the study without muscle biopsy.
- •Other comorbidities that prevent the patient from participating in the study examinations as judged by the investigator.
结局指标
主要结局
Physical performance, walking distance
时间窗: From baseline to 12 and 36 months
Change in walking distance (6MWT) in meters
Physical performance, peak VO2
时间窗: From baseline to 12 and 36 months
Change in peak oxygen uptake (peak VO2), measured in ml O2/kg/min
Physical performance, muscle strength
时间窗: From baseline to 12 and 36 months
Change in knee extension/flexion isokinetic strength (assessed by peak torque, Nm) and isometric strength (assessed by peak torque, Nm)
次要结局
- Body composition(From baseline to 12 and 36 months)
- Daily physical activity(From baseline to 12 and 36 months)
- Muscle tissue cellular composition(From baseline to 12 and 36 months)
- Whole body metabolism(From baseline to 12 and 36 months)
- Cardiovascular events(During follow-up of 10 years)
- Insulin resistance(From baseline to 12 and 36 months)
- Muscle tissue mitochondrial function(From baseline to 12 and 36 months)
- Muscle metabolism(From baseline to 12 and 36 months)
- Symptoms(From baseline to 12 and 36 months)
- Muscle tissue fiber types(From baseline to 12 and 36 months)
研究者
Henrik Wiggers
Professor
Aarhus University Hospital