Cardiomyopathy, DilatedACTIVE-DCMNCT04359238
activeDCM - Interventional Clinical Trial of Individualized Activity and Exercise Programs to Improve Outcome in Dilated Cardiomyopathy Guided by Longitudinal Biosensing With Apple Watch
A study testing Individualized excercise in people with Cardiomyopathy, Dilated and Heart Failure, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiomyopathy, Dilated, Heart Failure
- What is being tested?
- Individualized excercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2020to 4 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department III of Internal Medicine, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69115
About this study
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.
Read the 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 month 6 and month 12), which contain 9 ml EDTA (for DNA analysis, e.g. whole genome sequencing), 5 ml of PaxGene (for RNA analysis), 7.5 ml of plasma (for example for metabolite and RNA analysis) and 7.5 ml of serum (for example for metabolite and RNA analysis). A detailed medical history is taken during the basic examination. This is followed by detailed physical examination and diagnostics. A routine blood sample is taken to determine the values of electrolytes, NT-ProBNP, hsTnT, creatinine, urea and the blood count. Finally, the patients answer a questionnaire on Quality of Life (MHLFQ: The Minnesota Living with Heart Failure Questionnaire) and Depression (PHQ9).
Two thirds of the patients (n = 200; intervention groups) will regularly participate in an individually designed sports program for a period of 12 months. One third of the participants (n = 100; control group) will not participate in a sports program. As a SmartWatch is required for the study. SmartWatches will be made available to all subjects on the day of recruitment. These are Apple Watches (Series 4), which are provided by Apple Inc. On the Apple Watch, participants have access to an app, that was especially developed by us for the study. This app collects important information about the physical activity and symptoms of the patient (including pulse rate, duration of training, the number of floors, number of steps and ECGs). The Apple Watch is also used to send participants of the intervention group regular notifications about their training status and to remind them of their training.
The participants present themselves 4-6 weeks after recruitment in the department of sports medicine to perform a spiroergometry and a sports medical evaluation. A personalized sports program (depending on the severity of the disease) is created for the subjects of the intervention groups, which consists of strength and endurance training. The sports program will be carried out over a period of 12 months.
All subjects in the intervention groups receive follow-up visits on month 3, month 6, month 9 and month 12. The sports program can be adapted on these dates. The subjects who did not receive a personalized training program presente themselves for the follow-up examination on month 6 and month 12. Unwanted events during the training (including syncope, ICD therapy, injuries) are documented during the follow-up visits.
- Conditions
- Cardiomyopathy, Dilated, Heart Failure
- Being tested
- Individualized excercise
- Keywords
- Exercise, SmartWatch, Wearables, Digital Health, Dilated Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized excerciseBehavioural
The participants in the intervention group carry out regularly endurance and strength exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group with motivation messages | Active comparator | There are 100 patients in the intervention group with automated or observer initiated motivation messages. They receive an individualized training program with regular notifications about their training status via their SmartWatch. Receives: Behavioral: Individualized excercise |
| Intervention group without motivation messages | Active comparator | There are 100 patients in the intervention group without automated or observer initiated motivation messages. They receive an individualized training program without regular notifications about their training status via their SmartWatch. Receives: Behavioral: Individualized excercise |
| Control group | No intervention | 100 patients are in the control group without an individualized training program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum oxygen uptake (VO2max)
Change in maximum oxygen uptake (VO2max) from baseline to 12 months follow-up
Measured: 12 months
Secondary outcomes (1)
Quality of life (Patient Reported Outcome)
Change in quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Jun 2020
- Primary completion1 Apr 2024
- Study completion4 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiomyopathy, DilatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Apple Inc., The German Heart Foundation, Informatics for Life, e-Cardiology, German Cardiac Society, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Principal investigator, Benjamin Meder, University Hospital Heidelberg
- Investigators
- Benjamin Meder, Prof. Dr., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359238
- Sponsor's protocol ID
- ACTIVE-DCM
- Acronym
- ACTIVE-DCM
- Status last verified
- Mar 2026
- First submitted
- 21 Apr 2020
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wettstein R, Sedaghat-Hamedani F, Heinze O, Amr A, Reich C, Betz T, Kayvanpour E, Merzweiler A, Busch C, Mohr I, Friedmann-Bette B, Frey N, Dugas M, Meder B. A Remote Patient Monitoring System With Feedback Mechanisms Using a Smartwatch: Concept, Implementation, and Evaluation Based on the activeDCM Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Nov 22;12:e58441. doi: 10.2196/58441.
PubMed 39365164
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- activeDCM - Interventional Clinical Trial of Individualized Activity and Exercise Programs to Improve Outcome in Dilated Cardiomyopathy Guided by Longitudinal Biosensing With Apple Watch
- ClinicalTrials.gov ID
- NCT04359238
- Acronym / sponsor ID
- ACTIVE-DCM / ACTIVE-DCM
- Conditions
- Cardiomyopathy, Dilated, Heart Failure
- Keywords
- Exercise, SmartWatch, Wearables, Digital Health, Dilated Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Apple Inc., The German Heart Foundation, Informatics for Life, e-Cardiology, German Cardiac Society, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 month 6 and month 12), which contain 9 ml EDTA (for DNA analysis, e.g. whole genome sequencing), 5 ml of PaxGene (for RNA analysis), 7.5 ml of plasma (for example for metabolite and RNA analysis) and 7.5 ml of serum (for example for metabolite and RNA analysis). A detailed medical history is taken during the basic examination. This is followed by detailed physical examination and diagnostics. A routine blood sample is taken to determine the values of electrolytes, NT-ProBNP, hsTnT, creatinine, urea and the blood count. Finally, the patients answer a questionnaire on Quality of Life (MHLFQ: The Minnesota Living with Heart Failure Questionnaire) and Depression (PHQ9).
Two thirds of the patients (n = 200; intervention groups) will regularly participate in an individually designed sports program for a period of 12 months. One third of the participants (n = 100; control group) will not participate in a sports program. As a SmartWatch is required for the study. SmartWatches will be made available to all subjects on the day of recruitment. These are Apple Watches (Series 4), which are provided by Apple Inc. On the Apple Watch, participants have access to an app, that was especially developed by us for the study. This app collects important information about the physical activity and symptoms of the patient (including pulse rate, duration of training, the number of floors, number of steps and ECGs). The Apple Watch is also used to send participants of the intervention group regular notifications about their training status and to remind them of their training.
The participants present themselves 4-6 weeks after recruitment in the department of sports medicine to perform a spiroergometry and a sports medical evaluation. A personalized sports program (depending on the severity of the disease) is created for the subjects of the intervention groups, which consists of strength and endurance training. The sports program will be carried out over a period of 12 months.
All subjects in the intervention groups receive follow-up visits on month 3, month 6, month 9 and month 12. The sports program can be adapted on these dates. The subjects who did not receive a personalized training program presente themselves for the follow-up examination on month 6 and month 12. Unwanted events during the training (including syncope, ICD therapy, injuries) are documented during the follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group with motivation messages | Active comparator | Behavioral: Individualized excerciseThere are 100 patients in the intervention group with automated or observer initiated motivation messages. They receive an individualized training program with regular notifications about their training status via their SmartWatch. |
| Intervention group without motivation messages | Active comparator | Behavioral: Individualized excerciseThere are 100 patients in the intervention group without automated or observer initiated motivation messages. They receive an individualized training program without regular notifications about their training status via their SmartWatch. |
| Control group | No intervention | –100 patients are in the control group without an individualized training program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized excerciseThe participants in the intervention group carry out regularly endurance and strength exercises. | Behavioural | Intervention group with motivation messages, Intervention group without motivation messages |
Primary outcome
Maximum oxygen uptake (VO2max)
Time frame: 12 months
Change in maximum oxygen uptake (VO2max) from baseline to 12 months follow-up
1 secondary outcome
Quality of life (Patient Reported Outcome)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Derived from this study: PubMed 39365164Wettstein R, Sedaghat-Hamedani F, Heinze O, Amr A, Reich C, Betz T, Kayvanpour E, Merzweiler A, Busch C, Mohr I, Friedmann-Bette B, Frey N, Dugas M, Meder B. A Remote Patient Monitoring System With Feedback Mechanisms Using a Smartwatch: Concept, Implementation, and Evaluation Based on the activeDCM Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Nov 22;12:e58441. doi: 10.2196/58441.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Meder, Prof. Dr. principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized excercise in people with Cardiomyopathy, Dilated and Heart Failure, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum oxygen uptake (VO2max) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.