NCT03369938已完成不适用
Exercise Training in Patients With Left Ventricular Assist Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 10
- 主要终点
- change in maximal exercise capacity
研究概览
简要总结
The objective of the study is to test whether 12 weeks of structured supervised exercise training on top of usual care improves functional capacity in patients with end-stage heart failure with continuous flow left ventricular assist device (LVAD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic end-stage systolic heart failure
- •stable on left ventricular assist device, meaning
- •no major change in therapeutic regime within past 4 weeks: no new additional disease modifying drug (ACE inhibitor, ARB, sacubitril, beta-blocker), no change in disease modifying drug dosage more than 50% (excluded: diuretics), no initiation of a cardiac rehabilitation for a minimum of 4 weeks
- •post implantation ≥ 3 months
- •expected further period on the device for a minimum of 3 months after recruitment into the study
- •ability to complete the study in compliance with the protocol.
- •general ability of the patient to declare willingness to participate in the trial.
- •written informed consent
排除标准
- •acute illness that does not allow exercise, including unstable heart failure, acute myocarditis, acute pericarditis, stroke
- •untreated life-threatening cardiac arrhythmias
- •uncontrolled hypertension
- •intracardiac thrombus
- •inability to perform cardiopulmonary exercise testing at least 1 minute at 20W
- •uncontrolled diabetes
- •uncontrolled kidney disease
- •recent embolism
- •concurrent, continuous, or intermittent dobutamine therapy
- •complex ventricular arrhythmia at rest or appearing with exertion
- •supine resting heart rate > 100 beats per minute
- •severe pulmonary instability
- •hemodynamically relevant valvular disorders
- •significant change in cardiovascular medication within the previous 4 weeks (see inclusion criteria)
- •severe anemia (hemoglobin <8 g/dl), however patients with moderate anemia (hemoglobin <11 g/dl) may be recruited if clinically stable (investigator assessment)
- •clinically relevant musculoskeletal disease
结局指标
主要结局
change in maximal exercise capacity
时间窗: after 12 weeks of treatment
cardiopulmonary exercise testing (CPET; peakVO2)
次要结局
- change in submaximal exercise tolerance(after 12 weeks of treatment and 12 weeks of follow-up)
- change in muscle strength(after 12 weeks of treatment and 12 weeks of follow-up)
- change in body composition(after 12 weeks of treatment and 12 weeks of follow-up)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(after 12 weeks of treatment and 12 weeks of follow-up)
- 36-Item Short Form Survey (SF-36)(after 12 weeks of treatment and 12 weeks of follow-up)
- Patient Health Questionnaire (PHQ-9)(after 12 weeks of treatment and 12 weeks of follow-up)
- change in markers of neuroendocrine activation(after 12 weeks of treatment and 12 weeks of follow-up)
- change in ventilatory efficacy(after 12 weeks of treatment and 12 weeks of follow-up)
- change in echocardiographic parameters of cardiac morphology and function at rest and during exercise(after 12 weeks of treatment and 12 weeks of follow-up)
- change in daily physical activity(up to 12 weeks of treatment and 12 weeks of follow-up)
研究者
Univ.-Prof. Dr. med. Frank Edelmann
Professor for Cardiovascular Prevention and Clinical Heart Failure Research
Charite University, Berlin, Germany
研究点 (10)
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