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NCT Number: NCT07096973

Cardiac REhabilitation COhort at the Medicine Campus DaVos to invEstigate Recovery

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

  2. Incidence of all-cause rehospitalization post cardiac intervention or surgery

    Time frame: 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.

Secondary outcomes

  1. Patient reported quality of life (QoL)

    Time frame: Follow-up 1, 5 and 10 years after inclusion

    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.

  2. Re-surgery / Re-intervention

    Time frame: Follow-up 1, 5 and 10 years after inclusion

    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.

  3. New-Onset Atrial Fibrillation

    Time frame: Follow-up 1, 5 and 10 years after inclusion

    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.

  4. Cognitive Function

    Time frame: Follow-up 1, 5 and 10 years after inclusion

    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.

  5. Functional Capacity

    Time frame: Follow-up 1, 5 and 10 years after inclusion

    Functional capacity will be objectively assessed at baseline and discharge using the standardized 6-minute walk test (6MWT). At follow-up, functional status will be evaluated through patient-reported outcomes collected via structured interviews and questionnaires to estimate changes in physical performance and exercise tolerance over time.

Study contacts

Contact information is provided by the study sponsor or research team.

Reception / Front Desk Hochgebirgsklinik Davos

CONTACT

[email protected]

+41 81 417 44 44

Researchteam Hochgebirgsklinik Davos

CONTACT

[email protected]

+41 81 417 40 60

Sponsors and collaborators

Lead sponsor

Hochgebirgsklinik Davos

Other

Registry information

Acronym: RECOVER

Important dates

Study start
2025
Primary completion
2035
Study completion
2040
First posted
Jul 31, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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