NCT07096973

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
174mo left

Started Aug 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Aug 2025Aug 2040

First Submitted

Initial submission to the registry

July 21, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

August 5, 2025

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2035

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2040

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

10 years

First QC Date

July 21, 2025

Last Update Submit

September 11, 2025

Conditions

Keywords

cardiovascular diseasescardiac rehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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.

    Follow-up 1, 5 and 10 years after inclusion

  • 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.

    Follow-up 1, 5 and 10 years after inclusion

Secondary Outcomes (5)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hochgebirgsklinik Davos

Davos, Kanton Graubünden, 7265, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Blood (EDTA-blood, serum, plasma (EDTA), citrated), DNA, RNA, washed erythrocytes, PBMCs (peripheral blood mononuclear cell) * Urine * Stool * Tissue/ cells * Saliva * Hair

MeSH Terms

Conditions

Heart FailureHeart ArrestAcute Coronary SyndromeArrhythmias, CardiacCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesMyocardial IschemiaVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Researchteam Hochgebirgsklinik Davos

CONTACT

Reception / Front Desk Hochgebirgsklinik Davos

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 31, 2025

Study Start

August 5, 2025

Primary Completion (Estimated)

August 5, 2035

Study Completion (Estimated)

August 5, 2040

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations