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Atrial fibrillation (AF) is one of the most common forms of heart rhythm disorder in patients with cardiovascular diseases. The choice of treatment for AF is a complex problem, depending on the form (paroxysmal, persistent, permanent) of AF, clinical manifestations of cardiac arrhythmias, associated diseases, the effectiveness of antiarrhythmic drugs. The accumulated data to date indicate an efficacy of the method of radiofrequency ablation (RFA) in the treatment of the paroxysmal form of AF. The RFA procedure does not eliminate the pathological processes that take place during developed AF. This dictates the need to develop and test new technologies and physical rehabilitation programmes for patients. The positive clinical effects of physical rehabilitation programmes based on moderate-intensity exercises are well known. The search for drugs capable of improving the results of RFA for AF in patients becomes urgent. This creates the prerequisites for the study of the clinical efficacy of trimetazidine MV in the rehabilitation of patients with cardiac diseases who underwent treatment of AF with RFA, which will optimize the management of such patients in the inpatient and outpatient setting.
The study is interventional (Clinical Trial), randomized in parallel groups. Enrollment: 72 participants.
The 72 male patients were randomized in 3 groups. In 1st group (control) patients were taken antiarrhythmical drugs and anticoagulants. They did only usual activity without walking. Patients in 2nd group were taken antiarrhythmical drugs and anticoagulants, participated in rehabilitation programme. Twice a week they came in clinical center to engage in physical training with an instructor. The programe was lasted for 6 months. Also patients did they usual physical activity, practiced walking. Patients in 3rd group were taken antiarrhythmical drugs and anticoagulants, selective inhibitor of fat acids oxidation for 6 months. They did only usual activity without walking.
The examination was carried for all 72 patients. Before RFA patients took blood tests, performed echocardiography, completed psychological questionnaires. After 3 days they took blood tests, performed 6-minute walk testing, ECG monitoring, completed psychological questionnaires. One month after RFA patient performed veloergometry testing. Three months after RFA the performed 6-minute walk testing, ECG monitoring, took blood tests, completed psychological questionnaires. Six months after RFA patients took blood tests, performed echocardiography, 6-minute walk testing, ECG monitoring, veloergometry testing, completed psychological questionnaires. Onward was a follow up period for 6 months. At the time point of 12 months patients took blood tests, performed echocardiography, ECG monitoring, veloergometry testing, completed psychological questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical training | Experimental | Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months) |
|
| Trimetazidine | Experimental | Treatment of trimetazidine in addition to standart therapy |
|
| Control | No Intervention | Standard follow-up at the participating heart center |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical training program | Other |
| ||
| Trimetazidine |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Fibrillation Recurrence | Number of participants with reccurrence of atrial fibrillation after RFA | From RFA to 3 months |
| Atrial Fibrillation Recurrence | Number of participants with recurrence of atrial fibrillation after RFA | From 3 months to 6 months |
| Atrial Fibrillation Recurrence | Number of participants with recurrence of atrial fibrillation after RFA | From 6 months to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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study protocol
until December 2020
study protocol will be available upon request
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There were no significant study events
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Training | Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months) Physical training program |
| FG001 | Trimetazidine | Treatment of trimetazidine in addition to standard therapy Trimetazidine |
| FG002 | Control | Standard follow-up at the participating heart center |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Training | Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months) Physical training program |
| BG001 | Trimetazidine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Atrial Fibrillation Recurrence | Number of participants with reccurrence of atrial fibrillation after RFA | Posted | Count of Participants | Participants | From RFA to 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physical Training | Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months) Physical training program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maria Makhinova | National medical research center for therapy and preventive medicine | +79104803524 | longtimeaftertomorrow@gmail.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014292 | Trimetazidine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
Treatment of trimetazidine in addition to standart therapy
Trimetazidine
| BG002 | Control | Standard follow-up at the participating heart center |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Standard follow-up at the participating heart center
|
|
| Primary | Atrial Fibrillation Recurrence | Number of participants with recurrence of atrial fibrillation after RFA | Posted | Count of Participants | Participants | From 3 months to 6 months |
|
|
|
| Primary | Atrial Fibrillation Recurrence | Number of participants with recurrence of atrial fibrillation after RFA | Posted | Count of Participants | Participants | From 6 months to 12 months |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Trimetazidine | Treatment of trimetazidine in addition to standart therapy Trimetazidine | 0 | 24 | 0 | 24 |
| EG002 | Control | Standard follow-up at the participating heart center | 0 | 24 | 0 | 24 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Male |
|