Status:
RECRUITING
activeDCM - Interventional Clinical Trial of Individualized Activity and Exercise Programs to Improve Outcome in Dilated Cardiomyopathy Guided by Longitudinal Biosensing With Apple Watch
Lead Sponsor:
University Hospital Heidelberg
Collaborating Sponsors:
Apple Inc.
The German Heart Foundation
Conditions:
Cardiomyopathy, Dilated
Heart Failure
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The influence of an individualized sports program on dilated cardiomyopathy patients will be investigated in a randomized, prospective intervention study. 300 patients with dilated cardiomyopathy are ...
Detailed Description
The recruited subjects (n = 300) receive routine medical care on the day of randomization in our outpatient clinic. Furthermore, an additional blood sample is taken (further blood samples are taken on...
Eligibility Criteria
Inclusion
- Diagnosis of non-ischemic, dilated cardiomyopathy (DCM)
- EF ≤ 45%
- NYHA I-III
- Age 18 to 65 years
- The patient understood the study concept and the declaration of consent and signed and dated the declaration of consent
Exclusion
- Physical disability that is not compatible with exercise in the study
- Orthopedic diseases such as osteoarthritis or changes in the spine that lead to restrictions that are not compatible with exercise in the study
- Syncope within the past 3 months
- Pregnancy
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04359238
Start Date
June 1 2020
End Date
June 1 2024
Last Update
May 8 2024
Active Locations (1)
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1
Department III of Internal Medicine, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69115