RecruitingNot ApplicableNCT04359238

activeDCM - Interventional Clinical Trial of Individualized Activity and Exercise Programs to Improve Outcome in Dilated Cardiomyopathy Guided by Longitudinal Biosensing With Apple Watch


Sponsor

University Hospital Heidelberg

Enrollment

300 participants

Start Date

Jun 1, 2020

Study Type

INTERVENTIONAL

Conditions

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 included and examined over a period of 13 months. All participants will receive an Apple Watch, which serves for monitoring of activity and symptoms.The primary endpoint of the study is the change in maximum oxygen intake. In addition, the changes in well-being, objective parameters of cardiac function and the subject's compliance to his excercise program are of interest as secondary endpoints and for further exploratory research. In addition, the safety of a personalized sports program is evaluated. Molecules circulating in the blood (including proteins, RNA) are beeing measured at the beginning and in the course of the training program in order to be able to derive a connection between the training and the changed cardiovascular function. A gene analysis will be carried out, which serves to identify the genetic requirements of protective excercise.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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

Interventions

BEHAVIORALIndividualized excercise

The participants in the intervention group carry out regularly endurance and strength exercises.


Locations(1)

Department III of Internal Medicine, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

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NCT04359238


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