About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing CR at the HGK
Written informed consent
Age ≥ 18 years
Disqualifiers
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
Trial population
All patients referred to HGK for inpatient CR will be screened for eligibility according to inclusion and exclusion criteria. Study inclusion requires written informed consent, and the study and all -related procedures will be performed according to the Declaration of Helsinki. The study plans to enroll approximately 1'000 patients per year.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Composite of cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure
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
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.
Secondary outcomes
Patient reported quality of life (QoL)
Quality of life will be assessed using the EuroQol 5-Dimension (EQ-5D) questionnaire, a validated patient-reported outcome measure, administered at baseline and follow-up. The EQ-5D index score ranges from less than 0 (indicating health states worse than death) to 1 (perfect health), with higher scores reflecting better health-related quality of life. Changes in index scores will be analyzed to evaluate the effects of cardiac rehabilitation.
Re-surgery / Re-intervention
The incidence of repeat cardiovascular surgery or catheter-based interventions will be recorded within the follow-up period. This includes any planned or unplanned procedures related to the index condition (e.g., valve re-surgery, revascularization) and will be verified through medical records and registry linkage.
New-Onset Atrial Fibrillation
New-onset atrial fibrillation is defined as a first documented episode of AF after the index cardiac intervention or surgery, verified by ECG or rhythm monitoring. Occurrence will be assessed through medical records, telemetry data, and clinical follow-up.
Cognitive Function
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a standardized screening tool that evaluates multiple cognitive domains including memory, attention, executive function, and processing speed. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Assessments will be conducted at baseline and follow-up to detect changes or cognitive decline following the intervention.
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