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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
NA trial testing Individualized excercise in Cardiomyopathy, Dilated in 300 participants. Completed in 4 July 2025.
1 April 2024
Quick facts
| Lead sponsor | University Hospital Heidelberg |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 1 June 2020 |
| Primary completion | 1 April 2024 |
| Estimated completion | 4 July 2025 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Individualized excercise
Conditions studied
- Cardiomyopathy, Dilated — all drugs for Cardiomyopathy, Dilated →
- Heart Failure — all drugs for Heart Failure →
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):
-
Artificial intelligence to improve cardiovascular population health.
Meder B, Asselbergs FW, Ashley E. · · 2025 · cited 10× · PMID 40106837 · DOI 10.1093/eurheartj/ehaf125 -
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 -
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:
- PubMed search for NCT04359238
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cardiomyopathy, Dilated
Currently open trials in the same condition.
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- NCT06091475 — Therapy to Maintain Remission in Dilated Cardiomyopathy · NA · recruiting
- NCT05981092 — A Study About the Natural History in Adults With BAG3 Dilated Cardiomyopathy (a Type of Heart Disease) (BAG3 DCM) · active not recruiting
- NCT05321875 — Early Treatment With Candesartan vs Placebo in Genetic Carriers of Dilated Cardiomyopathy (EARLY-GENE Trial) · Phase 3 · recruiting
- NCT07527715 — Cardiac Magnetic Resonance-Clinical Prediction Model-Dilated Cardiomyopathy · recruiting
Other University Hospital Heidelberg trials
Trials by the same sponsor.
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- NCT07181928 — Is Mentalization-based Therapy More Effective Than Treatment-as-usual for Adolescents With Dissocial Disorders? · NA · not yet recruiting
- NCT06954623 — Partial Breast Re-irradiation for Breast Cancer · NA · recruiting
- NCT06913010 — DV 100 as a Framework for the Hospital Incident Command System · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04359238 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital Heidelberg
- Last refreshed: 24 March 2026
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