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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Department III of Internal Medicine, University Hospital Heidelberg
RECRUITING
Heidelberg
Contact Information
Primary
Benjamin Meder, Prof. Dr.
benjamin.meder@med.uni-heidelberg.de
0049 (0)6221 56-37948
Time Frame
Start Date: 2020-06-01
Estimated Completion Date: 2024-06-01
Participants
Target number of participants: 300
Treatments
Active_comparator: Intervention group with motivation messages
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.
Active_comparator: Intervention group without motivation messages
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.
No_intervention: Control group
100 patients are in the control group without an individualized training program.
Sponsors
Collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Informatics for Life, e-Cardiology, The German Heart Foundation, German Cardiac Society, Apple Inc.
Leads: University Hospital Heidelberg

This content was sourced from clinicaltrials.gov