Cost-effective Strategies to Improve Rehabilitative Outcomes for Heart Failure Patients With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Change in VO2max
研究概览
简要总结
Half of heart failure patients have preserved ejection fraction (HFpEF). Like patients with reduced ejection fraction (HFrEF), HFpEF patients suffer from exercise intolerance (low VO2max), which reduces physical function, quality of life, and survival. Strikingly, there is no medication proven to increase survival for HFpEF patients. Whereas exercise intolerance in HFrEF patients is the result of cardiovascular limitations, physical dysfunction in HFpEF patients is largely the result of peripheral abnormalities in skeletal muscle. Indeed, research in HFpEF patients identified that physical function and VO2peak are directly related to leg lean mass, and drugs focused on improving cardiovascular function have failed to improve VO2peak. Unfortunately, no therapy has been identified for this population that can concurrently improve cardiovascular and muscle health. The need for improved muscle therapies is reinforced by the fact that HFpEF patients are commonly older adults who are predisposed to muscle wasting. Strategic essential amino acid (EAA) ingestion has been shown to improve the adaptive response of muscle to exercise. Therefore, the investigators will determine, in HFpEF patients, the extent to which ingesting a strategic mixture of EAAs during an acute aerobic exercise training program enhances the response to this exercise strategy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60+ years of age
- •Able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- •Diagnosed with HFpEF as per established echocardiographic criteria (New York Heart Association Class II-III).
排除标准
- •Unstable angina, myocardial infarction in the past 4 weeks
- •Uncompensated heart failure
- •New York Heart Association class IV symptoms, complex ventricular arrhythmias, symptomatic severe aortic stenosis, acute pulmonary embolus, acute myocarditis, untreated high-risk proliferative retinopathy, recent retinal hemorrhage, uncontrolled hypertension, baseline blood screening abnormalities
- •Medication non-compliance
- •Medical / orthopedic conditions precluding exercise
- •Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
- •Subjects on anti-coagulation medication will not be eligible for the muscle biopsy procedure, but are deemed eligible for study participation if INR < 3.
结局指标
主要结局
Change in VO2max
时间窗: Change from pre to after the 4 week intervention
Change in maximal Aerobic Capacity
次要结局
- Change in Flow-mediated Dilation(Change from pre to after the 4 week intervention)
- Change in Pulse wave velocity(Change from pre to after the 4 week intervention)
- Change in Diastolic Function(Change from pre to after the 4 week intervention)
- Change in Skeletal Muscle mRNA expression(Change from pre to after the 4 week intervention)
研究者
Jared Dickinson
Assistant Professor
Arizona State University