Early-start Exercise Training After Acute Hemodynamic Decompensation in Patients With Chronic Heart Failure. A Multicenter, Randomized, Controlled Trial on Feasibility and Impact on Functional Capacity, Symptoms and Neurohumoral Activation.
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 18
- 主要终点
- Distance walked at 6-min walking test
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and the short-term effects of an early-start aerobic exercise training program on functional capacity, symptoms and neurohormonal activation in chronic heart failure patients with recent acute hemodynamic decompensation.
详细描述
Prescription of aerobic exercise training in stable chronic heart failure patients finds an evidence-based justification in the acknowledged long-term positive effects of aerobic exercise training on both functional capacity and prognosis in this population. In recent time, evidence has accumulated in normal subjects about short-term favorable effects of aerobic exercise training on sympatho-vagal balance and flow-mediated vasodilation, two physiological mechanisms known to be profoundly altered in the setting of acute hemodynamic decompensation of chronic heart failure. The possible extension of aerobic exercise training indication to chronic heart failure patients admitted for recent acute hemodynamic decompensation not stabilized as yet, may thus provide a valuable, low-cost tool to effectively manage such a high-risk and resource-absorbing population.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of chronic heart failure for at least 6 months, with ongoing acute decompensation defined as onset or worsening of heart failure signs and/or symptoms during the previous 15 days with need of intravenous diuretic and/or vasodilator therapy;
- •age >18 years
- •left ventricular ejection fraction <40%
- •proBNP >1000 pg/ml at admission
排除标准
- •ongoing cardiogenic shock
- •need of intravenous inotropic therapy
- •acute coronary syndrome during the preceding 3 months
- •clinical and/or instrumental evidence of myocardial ischemia and/or life-threatening arrhythmias
- •previous cardiac valve surgery
- •creatinine >2.5 mg/dl at admission
- •severe comorbidities limiting functional capacity
研究组 & 干预措施
Aerobic exercise training
干预措施: Aerobic exercise training (Other)
Standard physical therapy
干预措施: Standard physical therapy (Other)
结局指标
主要结局
Distance walked at 6-min walking test
时间窗: 12 days of intervention
Change from baseline in distance walked at 6-min walking test
次要结局
- Aerobic exercise training safety and tolerability(12 days of treatment)
- Levels of lymphocyte G protein-coupled receptor kinase-2(12 days of intervention)
- Patient-reported dyspnea, evaluated by a 7-point Likert scale(12 days of intervention)
- Levels of circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF)(12 days of intervention)
研究者
Alessandro Mezzani
MD
Fondazione Salvatore Maugeri