RecruitingNot ApplicableNCT04359238

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


Sponsor

University Hospital Heidelberg

Enrollment

300 participants

Start Date

Jun 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether personalized exercise programs — guided by continuous heart monitoring using an Apple Watch — can improve outcomes for people with dilated cardiomyopathy (DCM), a condition where the heart becomes enlarged and pumps poorly. Participants follow tailored activity plans while their heart activity is tracked over time. **You may be eligible if:** - You have been diagnosed with non-ischemic dilated cardiomyopathy (heart muscle disease not caused by blocked arteries) - Your heart's pumping function (ejection fraction) is 45% or less - You have mild to moderate heart failure symptoms (NYHA Class I–III) - You are 18 to 65 years old - You understand the study and have signed informed consent **You may NOT be eligible if:** - You have a physical disability that prevents you from exercising safely - You have joint or spine problems that significantly limit physical activity - You have fainted (syncope) in the past 3 months - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIndividualized excercise

The participants in the intervention group carry out regularly endurance and strength exercises.


Locations(1)

Department III of Internal Medicine, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

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NCT04359238


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