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

NCT ID: NCT04359238

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2024-06-01

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.

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.

Conditions

Cardiomyopathy, Dilated; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Individualized excercise

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Individualized excercise

Intervention Type: BEHAVIORAL

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Individualized excercise

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apple Inc.

INDUSTRY

Sponsor Role: collaborator

The German Heart Foundation

OTHER

Sponsor Role: collaborator

Informatics for Life

UNKNOWN

Sponsor Role: collaborator

e-Cardiology

UNKNOWN

Sponsor Role: collaborator

German Cardiac Society

OTHER

Sponsor Role: collaborator

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Meder

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Meder, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

Department III of Internal Medicine, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Benjamin Meder, Prof. Dr.

Role: CONTACT

benjamin.meder@med.uni-heidelberg.de

0049 (0)6221 56-37948

Facility Contacts

Benjamin Meder, Prof. Dr.

Role: primary

benjamin.meder@med.uni-heidelberg.de

0049 (0)6221 56-37948

Other Identifiers

ACTIVE-DCM

Identifier Type: -

Identifier Source: org_study_id