Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04359238 |
| Other study ID # |
ACTIVE-DCM |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University Hospital Heidelberg |
| Contact |
Benjamin Meder, Prof. Dr. |
| Phone |
0049 (0)6221 56-37948 |
| Email |
benjamin.meder[@]med.uni-heidelberg.de |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
