Trial Outcomes & Findings for Efficacy of Personalized Exercise Program and Trimetazidine in Rehabilitation of Patients After RFA of AF (NCT NCT04511520)
NCT ID: NCT04511520
Last Updated: 2021-06-09
Results Overview
Number of participants with reccurrence of atrial fibrillation after RFA
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
From RFA to 3 months
Results posted on
2021-06-09
Participant Flow
There were no significant study events
Participant milestones
| Measure |
Physical Training
Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)
Physical training program
|
Trimetazidine
Treatment of trimetazidine in addition to standard therapy
Trimetazidine
|
Control
Standard follow-up at the participating heart center
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Physical Training
n=24 Participants
Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)
Physical training program
|
Trimetazidine
n=24 Participants
Treatment of trimetazidine in addition to standart therapy
Trimetazidine
|
Control
n=24 Participants
Standard follow-up at the participating heart center
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 8.5 • n=24 Participants
|
56.4 years
STANDARD_DEVIATION 8.1 • n=24 Participants
|
55.0 years
STANDARD_DEVIATION 9.8 • n=24 Participants
|
56.1 years
STANDARD_DEVIATION 8.8 • n=72 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
72 Participants
n=72 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From RFA to 3 monthsNumber of participants with reccurrence of atrial fibrillation after RFA
Outcome measures
| Measure |
Physical Training
n=24 Participants
Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)
Physical training program
|
Trimetazidine
n=24 Participants
Treatment of trimetazidine in addition to standard therapy
Trimetazidine
|
Control
n=24 Participants
Standard follow-up at the participating heart center
|
|---|---|---|---|
|
Atrial Fibrillation Recurrence
|
2 Participants
|
3 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: From 3 months to 6 monthsNumber of participants with recurrence of atrial fibrillation after RFA
Outcome measures
| Measure |
Physical Training
n=24 Participants
Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)
Physical training program
|
Trimetazidine
n=24 Participants
Treatment of trimetazidine in addition to standard therapy
Trimetazidine
|
Control
n=24 Participants
Standard follow-up at the participating heart center
|
|---|---|---|---|
|
Atrial Fibrillation Recurrence
|
1 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From 6 months to 12 monthsNumber of participants with recurrence of atrial fibrillation after RFA
Outcome measures
| Measure |
Physical Training
n=24 Participants
Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)
Physical training program
|
Trimetazidine
n=24 Participants
Treatment of trimetazidine in addition to standard therapy
Trimetazidine
|
Control
n=24 Participants
Standard follow-up at the participating heart center
|
|---|---|---|---|
|
Atrial Fibrillation Recurrence
|
6 Participants
|
6 Participants
|
9 Participants
|
Adverse Events
Physical Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trimetazidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Maria Makhinova
National medical research center for therapy and preventive medicine
Phone: +79104803524
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place