NCT02122835撤回不适用
Vascular and Metabolic Responses to Exercise Training in Heart Failure With or Without Type 2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- exercise capacity
研究概览
简要总结
The purpose of this study is to understand the differences in how patients with heart failure respond to exercise training compared to patients with heart failure and type 2 diabetes.
详细描述
The investigators will measure exercise capacity in patients with heart failure or heart failure plus type 2 diabetes prior to and following a 12-week exercise training program (5d/wk, 30 min/d, 60-75% VO2max) to determine whether improvements in exercise capacity in response to exercise training are mitigated in patients with combined heart failure plus type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥50 yr of age
- •New York Heart Association class II-III CHF and ejection fraction ≤35%
- •receiving optimal medical therapy
- •sedentary (≤ 30 min/wk structured physical activity).
- •Half of volunteers (n=30) will have a diagnosis of type 2 diabetes (CHF+T2D).
排除标准
- •changes in medication ≤6 wk prior to enrollment
- •major cardiovascular event or procedure ≤6 wk prior to enrollment
- •foot ulcers
- •advanced neuropathy
- •co-morbidities or other limitations that may interfere with or prevent volunteers from safely completing the exercise training
- •fixed rate pacemaker
- •type 1 diabetes mellitus
结局指标
主要结局
exercise capacity
时间窗: baseline, 12 weeks
measured as peak oxygen consumption as well as treadmill time to exhaustion, also known as cardiopulmonary fitness
次要结局
- flow-mediated dilation(baseline, 12 weeks)
- nitrite flux during exercise(baseline, 12 weeks)
研究者
研究点 (2)
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