Clinical trial NCT04359238: activeDCM - Interventional Clinical Trial of Individualized Activity and Exercise Programs to Improve Outcome in Dilated Cardiomyopathy Guided by Longitudinal Biosensing With Apple Watch
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiomyopathy, Dilated
Heart Failure
Keywords: Exercise
SmartWatch
Wearables
Digital Health
Dilated Cardiomyopathy
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Apple Inc.
name: The German Heart Foundation
name: Informatics for Life
name: e-Cardiology
name: German Cardiac Society
name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2020-04-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Maximum oxygen uptake (VO2max)
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life (Patient Reported Outcome)
timeFrame: 12 months
Other outcomes:
measure: Cardiac biomarkers
timeFrame: 12 months
measure: Cardiac function
timeFrame: 12 months
measure: Arrhythmias
timeFrame: 12 months
measure: Heart failure
timeFrame: 12 months
measure: Compliance
timeFrame: 12 months
Locations:
city: Heidelberg
country: Germany
facility: Department III of Internal Medicine, University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Heidelberg
name: Benjamin Meder, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: