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NCT04359238Completed

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

Source: ClinicalTrials.gov · Last updated 24 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
300 (actual)
First submitted
21 Apr 2020
Start date
1 Jun 2020
Primary completion date
1 Apr 2024
Lead sponsor
University Hospital Heidelberg
NCT number
NCT04359238

What you commit to

  • Study type: Interventional
  • Participants enrolled: 300
  • From 1 Jun 2020 to the primary completion date, 1 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Orthopedic diseases such as osteoarthritis or changes in the spine that lead to restrictions that are not compatible with exercise in the study

Other

  • Physical disability that is not compatible with exercise in the study
  • Syncope within the past 3 months
  • Pregnancy

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department III of Internal Medicine, University Hospital Heidelberg
Coordinator of this site? Confirm its status
HeidelbergGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.