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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)

Primary Purpose

Cardiomyopathy, Dilated, Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Individualized excercise
Sponsored by
University Hospital Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiomyopathy, Dilated focused on measuring Exercise, SmartWatch, Wearables, Digital Health, Dilated Cardiomyopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department III of Internal Medicine, University Hospital HeidelbergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Intervention group with motivation messages

Intervention group without motivation messages

Control group

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life (Patient Reported Outcome)
Change in quality of life

Full Information

First Posted
April 21, 2020
Last Updated
May 17, 2022
Sponsor
University Hospital Heidelberg
Collaborators
Apple Inc., The German Heart Foundation, Informatics for Life, e-Cardiology, German Cardiac Society, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
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1. Study Identification

Unique Protocol Identification Number
NCT04359238
Brief Title
activeDCM - Interventional Clinical Trial of Individualized Activity and Exercise Programs to Improve Outcome in Dilated Cardiomyopathy Guided by Longitudinal Biosensing With Apple Watch
Acronym
ACTIVE-DCM
Official Title
activeDCM - Interventional Clinical Trial of Individualized Activity and Exercise Programs to Improve Outcome in Dilated Cardiomyopathy Guided by Longitudinal Biosensing With Apple Watch
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg
Collaborators
Apple Inc., The German Heart Foundation, Informatics for Life, e-Cardiology, German Cardiac Society, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy, Dilated, Heart Failure
Keywords
Exercise, SmartWatch, Wearables, Digital Health, Dilated Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group with motivation messages
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention group without motivation messages
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
100 patients are in the control group without an individualized training program.
Intervention Type
Behavioral
Intervention Name(s)
Individualized excercise
Intervention Description
The participants in the intervention group carry out regularly endurance and strength exercises.
Primary Outcome Measure Information:
Title
Maximum oxygen uptake (VO2max)
Description
Change in maximum oxygen uptake (VO2max) from baseline to 12 months follow-up
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life (Patient Reported Outcome)
Description
Change in quality of life
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Cardiac biomarkers
Description
Change in Troponin und NTproBNP
Time Frame
12 months
Title
Cardiac function
Description
Change in systolic and diastolic cardiac function
Time Frame
12 months
Title
Arrhythmias
Description
Change in frequency of arrhythmias
Time Frame
12 months
Title
Heart failure
Description
Change in frequency of hospitalization and NYHA class
Time Frame
12 months
Title
Compliance
Description
Change in compliance concerning excercise program
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Meder, Prof. Dr.
Phone
0049 (0)6221 56-37948
Email
benjamin.meder@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Meder, Prof. Dr.
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department III of Internal Medicine, University Hospital Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69115
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Meder, Prof. Dr.
Phone
0049 (0)6221 56-37948
Email
benjamin.meder@med.uni-heidelberg.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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