Identifying Markers of Exercise Training in Heart Failure
概览
- 阶段
- 不适用
- 干预措施
- Acute exercise
- 疾病 / 适应症
- Heart Failure
- 发起方
- Stanford University
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Proteomic Profile: Chronic
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
The heart failure syndrome that occurs when the heart is too sick to properly do its job. One of the main symptoms is difficulty with exercise. One way to improve symptoms is to start patients in a 12 week exercise program called cardiac rehabilitation. Cardiac rehabilitation been shown to improve symptoms for heart failure patients. However, the investigators do not know exactly what exercise does to the molecules that make up the human body. If the investigators could answer this question, the investigators might find a whole new way to treat the symptoms of heart failure. Therefore the investigators want to know what molecules might be responsible for the benefits of exercise. The plan for this study is to measure the levels of thousands of proteins in blood samples which come from people with heart failure and see how those levels change after 12 weeks of cardiac rehabilitation, compared to the protein levels in patients whose cardiac rehabilitation is delayed until after the study period. If the investigators know the proteins that change with exercise, the investigators can then look to see if targeting these proteins with medicines can mimic the benefits of exercise. The long term goal of our work is to identify "exercise-in-a-pill" medicines that will help people with heart failure.
研究者
Daniel Katz
Study Investigator
Stanford University
入排标准
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18-89
- •Patients must carry a diagnosis of heart failure with ejection fraction \< 40%
- •Be willing to participate in cardiac rehabilitation, and not already done so in the last year
- •Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
- •Must be able to exercise on a treadmill
排除标准
- •Inability to complete CPET or participate in CR (verbal/chart)
- •Syncope during CPET within the last 6 mos, sustained VT on CPET, hemodynamically significant arrhythmia during CPET (verbal/chart)
- •BMI \>= 38 (verbal/chart)
- •History of a bleeding disorder or clotting abnormality (verbal/chart)
- •Clinical diagnosis of severe Chronic Obstructive Pulmonary Disease (COPD) (verbal/chart)
- •History of malignancy not considered in remission (verbal/chart)
- •Cirrhosis (verbal/chart)
- •Thyroid disease (verbal/chart)
- •Thyroid Stimulating Hormone (TSH) value outside of the normal range for the laboratory within the last 1 year
- •Individuals with hypothyroidism may be referred to their primary care provider (PCP) for evaluation and retested; any medication change must be stable for ≥3 months prior to retesting
研究组 & 干预措施
Active arm: Acute exercise
This arm includes two-thirds of enrollees and focuses on acute effects of exercise. Qualifying participants with heart failure randomized to this arm will undergo a 40 minute bout of moderate intensity exercise. Blood samples will be collected before and after the acute bout at 10, 30, and 210 minutes after exercise.
干预措施: Acute exercise
Control arm: No exercise (Acute Comparison)
This arm includes one-third of enrollees and serves as control. Qualifying participants with heart failure randomized to this arm will begin with a 40 minute period of rest. Blood samples will be collected before and after the the 40 minute period at 10, 30, and 210 minutes after the start.
Active Arm: 12 weeks Cardiac Rehabilitation
This arm includes two-thirds of enrollees for the training intervention and focuses on chronic effects of exercise. Participants have a baseline blood sample and then go to cardiac rehabilitation for a 12 week period. A single blood sample will be obtained at 6 weeks. The participants will return after the 12 weeks of cardiac rehabilitation for another single blood sample.
干预措施: Cardiac rehabilitation
Control: No Exercise (Training)
Participants receive baseline fasting blood sample and then defer cardiac rehabilitation for a 12 week period. A single blood sample will be obtained at 6 weeks of this control intervention period. 12 weeks after enrollment, patients will return for another single blood sample.
结局指标
主要结局
Change in Proteomic Profile: Chronic
时间窗: Baseline vs week 12 proteomic profile
Patients will have proteomic profiling performed at baseline, prior to the intervention period, and again following the 12 week intervention. Proteomic profiling measures levels of \~3000 proteins in the blood, so the changes in the global proteome can be assessed after the intervention period.
Change in Proteomic Profile: Acute
时间窗: Acute bout vs control; Baseline vs week 12 proteomic profile of acute exercise
Patients will have proteomic profiling performed at baseline, prior to the acute bout of exercise, and again following the 12 week intervention. Proteomic profiling measures levels of \~3000 proteins in the blood, so the changes in the global proteome can be assessed before and after the acute exercise bout. Comparisons can be drawn between between those exercising and those not exercising (at acute bout #1), but also can be compared between those who did and did not not undergo cardiac rehabilitation (at acute bout #2).
次要结局
- Proteomic predictors of Cardiopulmonary fitness(Baseline vs week 12 proteomic profile)