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临床试验/NCT05162859
NCT05162859已完成不适用

Exercise Training in Heart Failure With Preserved Ejection Fraction - a Long-term Follow-up

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
Change in peak oxygen consumption (mL/kg/min)

研究概览

简要总结

Exercise training is an effective therapy for patients with heart failure with preserved ejection fraction. However, it is unclear, whether a one-year intervention has a sustainable effect beyond the active study phase. Hence, this study is a long-term follow-up of patients that were recruited for the OptimEx-Clin and Ex-DHF trials in Munich.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients that were previously randomized to OptimEx-Clin or Ex-DHF in Munich
  • Written informed consent

排除标准

  • Pregnancy / breastfeeding

结局指标

主要结局

Change in peak oxygen consumption (mL/kg/min)

时间窗: From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years)

次要结局

  • Change in quality of life(From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years))
  • Time to first cardiovascular event(From Last Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 3.3 to 8.2 years))
  • Change in left ventricular ejection fraction (%)(From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years))
  • Change in ventilation-to-carbon-dioxide production slope(From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years))
  • Change in oxygen consumption at the first ventilatory threshold (mL/kg/min)(From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years))
  • Change in E/e'(From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years))

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (1)

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