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NCT04359238: ACTIVE-DCM

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

Completed NA Last updated 24 March 2026
What this trial tests

NA trial testing Individualized excercise in Cardiomyopathy, Dilated in 300 participants. Completed in 4 July 2025.

Timeline
1 June 2020
Primary endpoint
1 April 2024
4 July 2025

Quick facts

Lead sponsorUniversity Hospital Heidelberg
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment300
Start date1 June 2020
Primary completion1 April 2024
Estimated completion4 July 2025
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital Heidelberg

Who can join

Adults 18 to 65, any sex, with Cardiomyopathy, Dilated or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Artificial intelligence to improve cardiovascular population health.
    Meder B, Asselbergs FW, Ashley E. · · 2025 · cited 10× · PMID 40106837 · DOI 10.1093/eurheartj/ehaf125
  2. A Remote Patient Monitoring System With Feedback Mechanisms Using a Smartwatch: Concept, Implementation, and Evaluation Based on the activeDCM Randomized Controlled Trial.
    Wettstein R, Sedaghat-Hamedani F, Heinze O, Amr A, et al · · 2024 · cited 6× · PMID 39365164 · DOI 10.2196/58441
  3. Personalized care in dilated cardiomyopathy: Rationale and study design of the activeDCM trial.
    Sedaghat-Hamedani F, Amr A, Betz T, Kayvanpour E, et al · · 2024 · cited 4× · PMID 39010317 · DOI 10.1002/ehf2.14970

Verify or expand the search:

Other recruiting trials for Cardiomyopathy, Dilated

Currently open trials in the same condition.

Other University Hospital Heidelberg trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04359238.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing