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

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.

Conditions

• Cardiomyopathy, Dilated
• Heart Failure

Interventions

BEHAVIORAL

Individualized excercise

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

Sponsors & Collaborators

• Apple Inc.

  collaborator INDUSTRY

• The German Heart Foundation

  collaborator OTHER

• Informatics for Life

  collaborator UNKNOWN

• e-Cardiology

  collaborator UNKNOWN

• German Cardiac Society

  collaborator OTHER

• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

  collaborator OTHER

• University Hospital Heidelberg

  lead OTHER

Principal Investigators

• Benjamin Meder, Prof. Dr. · University Hospital Heidelberg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-01

Primary Completion

2024-04-01

Completion

2025-07-04

Countries

• Germany

Study Locations