NCT04359238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2025

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

April 21, 2020

Last Update Submit

March 23, 2026

Conditions

Cardiomyopathy, DilatedHeart Failure

Keywords

ExerciseSmartWatchWearablesDigital HealthDilated Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • Maximum oxygen uptake (VO2max)

    Change in maximum oxygen uptake (VO2max) from baseline to 12 months follow-up

    12 months

Secondary Outcomes (1)

  • Quality of life (Patient Reported Outcome)

    12 months

Other Outcomes (5)

  • Cardiac biomarkers

    12 months

  • Cardiac function

    12 months

  • Arrhythmias

    12 months

  • +2 more other outcomes

Study Arms (3)

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.

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.

Behavioral: Individualized excercise

Control group

NO INTERVENTION

100 patients are in the control group without an individualized training program.

Interventions

Individualized excerciseBEHAVIORAL

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

Intervention group with motivation messagesIntervention group without motivation messages

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department III of Internal Medicine, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location

MeSH Terms

Conditions

Cardiomyopathy, DilatedHeart FailureMotor Activity

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Study Officials

  • Benjamin Meder, Prof. Dr.

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

June 1, 2020

Primary Completion

April 1, 2024

Study Completion

July 4, 2025

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

DE(1)