Exercise Training to Improve Pulmonary Haemodynamic and Right Ventricular Function in Heart Failure Patients With Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Maximal oxygen uptake (VO2max) measured in mL/kg/min
研究概览
简要总结
This research study is being done to find out if exercise therapy can help improve the heart function, overall health, and quality of life of patients with pulmonary hypertension caused by heart failure.
详细描述
The purpose of this research is to see if taking part in structured exercise training will improve the ability to exercise, the function of the heart, and the function of the blood vessels that supply the lungs in patients with heart failure and pulmonary hypertension. After enrollment all patients will complete exercise testing. Patients will be randomized to either 10 weeks of exercise training (3 times per week) or will continue standard medical care. All patients will undergo detailed exercise testing before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •NYHA functional class I-IIIb.
- •LVEF < 40%.
- •Clinically-stable for > 3 months [no change in disease status or medication].
- •Willing and able to provide written informed consent and perform cycle-ergometer or treadmill based exercise.
排除标准
- •NYHA class IV HF.
- •Diagnosis of diastolic HF.
- •Comorbidities such as obesity (BMI >36), uncontrolled systemic hypertension, type 2 diabetes, and COPD (FEV1 <50%).
- •Musculoskeletal or other conditions that would limit exercise participation.
- •Pregnant or nursing women
研究组 & 干预措施
Exercise Training
Two sets of exercise testing (before and after) 10 weeks of supervised exercise training (3 sessions per week) at Mayo Clinic Florida.
干预措施: Exercise Training (Other)
Control Groups
Two sets of exercise testing while continuing with standard medical care in between.
结局指标
主要结局
Maximal oxygen uptake (VO2max) measured in mL/kg/min
时间窗: 10 weeks
VO2max is the maximal measured oxygen uptake during a symptom limited exercise test.
次要结局
- Right ventricular contractile function measured as % fractional area change (RV FAC).(10 weeks)
- Left ventricular contractile function measured as % fractional area change (LV FAC).(10 weeks)
- Mean pulmonary arterial pressure (mPAP) measured in mmHg(10 weeks)
- Pulmonary vascular resistance (PVR) measured in dynes(10 weeks)
- Slope of the relationship between mean pulmonary arterial pressure and cardiac output (mPAP-Q slope) measured in mmHg/L/min.(10 weeks)