NCT03078972进行中（未招募）不适用
Effective Mechanical Circulatory Support on Exercise Capacity in Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in the sympathetic neural response.
研究概览
简要总结
This study will evaluate how the cardiovascular system interacts with mechanical hearts to provide blood flow to the body during exercise. Two aims are proposed: 1) to determine the impact of a mechanical heart on exercise pressor reflexes in heart failure patients; and 2) to define the primary determinant(s) of exercise capacity in heart failure patients before and after device implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 是
入选标准
- •Individuals with severely reduced left ventricular systolic function that are scheduled to undergo LVAD insertion
排除标准
- •uncontrolled diabetes with peripheral neuropathy (interferes with acquisition of MSNA signal)
- •Individuals with clinical right ventricular failure, defined as moderate-severely reduced RV systolic function on echocardiography, or clinical evidence of RV failure (elevated jugular venous pressures, significant peripheral edema)
- •Individuals with moderate-severe preexisting aortic insufficiency, as these patients will typically undergo a Park stitch at time of CF-LVAD insertion to permanently close the aortic valve and prevent worsening aortic insufficiency; and
- •Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease)
- •Mild Heart Failure -
- •Inclusion Criteria:
- •Individuals with medically managed left ventricular systolic function that are NOT scheduled to undergo LVAD insertion
- •HF patients with ejection fraction <35-40%
- •Exclusion Criteria:
- •Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC")
- •Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease)
- •History of uncontrolled arrhythmias (e.g. ventricular tachycardia or nonsustained ventricular tachycardia).
- •Healthy Controls -
- •Inclusion Criteria:
- •Persons without a past medical history of cardiovascular disease or related disease (e.g. hypertension, diabetes, peripheral vascular disease, arrhythmias, stroke/transient ischemic attack) and are not taking any cardiac-related medications (e.g. antihypertensive medications)
- •Exclusion Criteria:
- •Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC")
- •Disorders that adversely influence exercise ability (e.g. arthritis, peripheral ascular disease).
结局指标
主要结局
Changes in the sympathetic neural response.
时间窗: 4 weeks prior to implantation and 6 months post implantation.
The primary outcome will be the difference in the muscle sympathetic neural response (MSNA) to handgrip and post-exercise circulatory arrest (PECA) before and after Continuous-flow left ventricular assist device (CF-LVAD) insertion
Change in VO2.
时间窗: 4 weeks prior to implantation and 6 months post implantation.
The primary outcome will be the change in the VO2 (maximum rate of oxygen consumption) before and after CF-LVAD insertion.
次要结局
- Changes in the hemodynamic response.(4 weeks prior to implantation and 6 months post implantation.)
- Oxygen uptake and utilization(4 weeks prior to implantation and 6 months post implantation.)
- VO2 relationship and ventilatory threshold (1)(4 weeks prior to implantation and 6 months post implantation.)
- VO2 relationship and ventilatory threshold (2).(4 weeks prior to implantation and 6 months post implantation.)
- VO2 relationship and ventilatory threshold (4).(4 weeks prior to implantation and 6 months post implantation.)
- VO2 relationship and ventilatory threshold (3).(4 weeks prior to implantation and 6 months post implantation.)
研究者
研究点 (1)
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