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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Cardiomyopathy, Dilated
• Intervention / Treatment: Behavioral: Individualized 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin Meder, Prof. Dr.; Phone Number: 0049 (0)6221 56-37948; Email: benjamin.meder@med.uni-heidelberg.de

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69115
      • Recruiting
      • Department III of Internal Medicine, University Hospital Heidelberg
      • Contact: Benjamin Meder, Prof. Dr.; Phone Number: 0049 (0)6221 56-37948; Email: benjamin.meder@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Individualized excercise; The participants in the intervention group carry out regularly endurance and strength exercises.
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.	Behavioral: Individualized excercise; The participants in the intervention group carry out regularly endurance and strength exercises.
No Intervention: Control group; 100 patients are in the control group without an individualized training program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum oxygen uptake (VO2max)	Change in maximum oxygen uptake (VO2max) from baseline to 12 months follow-up	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (Patient Reported Outcome)	Change in quality of life	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac biomarkers	Change in Troponin und NTproBNP	12 months
Cardiac function	Change in systolic and diastolic cardiac function	12 months
Arrhythmias	Change in frequency of arrhythmias	12 months
Heart failure	Change in frequency of hospitalization and NYHA class	12 months
Compliance	Change in compliance concerning excercise program	12 months

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Collaborators: The German Heart Foundation; Apple Inc.; Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK); German Cardiac Society; Informatics for Life; e-Cardiology
• Investigators: Principal Investigator: Benjamin Meder, Prof. Dr., University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Dilated Cardiomyopathy; Digital Health; Wearables; SmartWatch
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: ACTIVE-DCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No