跳至主要内容
临床试验/NCT07096973
NCT07096973招募中不适用

Cardiac REhabilitation COhort at the Medicine Campus DaVos to invEstigate Recovery

Hochgebirgsklinik Davos1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2025年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
1
主要终点
Composite of cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure

研究概览

简要总结

The RECOVER study, titled Cardiac Rehabilitation Cohort at the Medicine Campus Davos for Exploration of Recovery, is a prospective, non-interventional, monocentric cohort study conducted at the Hochgebirgsklinik Davos. The study is sponsored by Medicine Campus Davos AG and the Kühne Foundation, with an estimated start date in July 2025 and planned completion by December 2034, with the possibility of extension.

The principal investigator of the study is PD Dr. David Niederseer from Hochgebirgsklinik Davos, who also represents the study. The research team includes co-investigators such as Prof. Dr. Stefan Blankenberg and Prof. Dr. Andreas Ziegler from Cardio-CARE, Medicine Campus Davos, as well as Dr. Jan Vontobel from Hochgebirgsklinik Davos.

The study will enroll patients referred to Hochgebirgsklinik Davos for cardiac rehabilitation who provide informed consent. Cardiac rehabilitation is an evidence-based therapy for patients with heart disease, including those who have undergone cardiac procedures or surgeries.

The primary objectives are to evaluate baseline patient characteristics, rehabilitation strategies, predictors of recovery, and clinical outcomes during and after rehabilitation. To support this, a detailed database and biobank will be established to allow for comprehensive phenotyping, extensive clinical assessments, and long-term follow-up.

RECOVER seeks to gain translational insights into how patient-specific factors - such as genetics, plasma, digital and clinical biomarkers, and comorbidities - influence long-term clinical outcomes. The goal is to identify modifiable risk factors to optimize individualized therapeutic approaches in cardiac rehabilitation.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing CR at the HGK
  • Written informed consent
  • Age ≥ 18 years

排除标准

  • Insufficient knowledge of the German language to understand study documents, the interview, or questionnaires interview without translation
  • Physical or psychological incapability to participate in the study

结局指标

主要结局

Composite of cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure

时间窗: Follow-up 1, 5 and 10 years after inclusion

Outcome assessment will be conducted through a combination of structured telephone follow-up, systematic collection of relevant medical records from the time of inclusion to the follow-up visit, patient-completed questionnaires, and analysis of data from national health and mortality registries.

Incidence of all-cause rehospitalization post cardiac intervention or surgery

时间窗: Follow-up 1, 5 and 10 years after inclusion

All-cause rehospitalization is defined as any unplanned hospital admission, regardless of cause, occurring following the index cardiac intervention or surgery. This includes admissions to any inpatient care facility for diagnostic, therapeutic, or emergency reasons, excluding planned elective procedures or routine follow-up admissions. Data will be obtained through structured follow-up, review of relevant hospital records, and linkage with national health insurance and hospital discharge registries to ensure comprehensive capture of rehospitalization events.

次要结局

  • Patient reported quality of life (QoL)(Follow-up 1, 5 and 10 years after inclusion)
  • Re-surgery / Re-intervention(Follow-up 1, 5 and 10 years after inclusion)
  • New-Onset Atrial Fibrillation(Follow-up 1, 5 and 10 years after inclusion)
  • Cognitive Function(Follow-up 1, 5 and 10 years after inclusion)
  • Functional Capacity(Follow-up 1, 5 and 10 years after inclusion)

研究者

发起方
Hochgebirgsklinik Davos
申办方类型
Other
责任方
Sponsor

研究点 (1)

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