Atrial Fibrillation Paroxysmal
Conditions
Keywords
rehabilitation, atrial fibrillation, physical training, radiofrequency ablation
Brief summary
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.
Detailed description
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.
Interventions
DRUGTrimetazidine
Sponsors
National Research Center for Preventive Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* treated for atrial fibrillation with radiofrequency ablation * cardiac disease * providing written informed consent
Exclusion criteria
* Congenital and acquired heart defects. * Acute coronary syndrome (unstable angina, myocardial infarction), myocardial revascularization during the previous 6 months * Transient ischemic attack, stroke in history. * Arterial hypertension (BP ≥160/100 мм. рт. ст.) * The risk of thromboembolic complications on a scale CHA2DS2-VASc\> 2 * Risk of hemorrhagic complications of anticoagulant therapy (HAS-BLED\> 3 points on the scale). * Complications after RFA. * Chronic heart failure above III FC (NYHA), ejection fraction (EF) \<40%. * Acute thrombophlebitis, complicated forms of varicose veins (thrombophlebitis, phlebothrombosis). * Pronounced atherosclerosis of peripheral arteries (intermittent claudication), requiring surgical intervention. * Violation of conductivity: AV-blockade 2-3 degrees, complete blockade of the bundle of the His bundle * The presence of an implanted pacemaker pacemaker / pacemaker with a resynchronization function/cardioverter-defibrillator) * Conduct RFA on AF earlier. * The presence of a history of syncopal states. * Diabetes mellitus type 1 and 2 in the stage of decompensation. * Acute conditions: infection, exacerbation of chronic diseases in a period of less than 1 month prior to the study; severe injury, surgical interventions other than RFA for a period of less than 2 months from the start of the study * Renal failure (creatinine levels above 300 µmol / L or 3.5 mg / dL). * Patient's refusal to participate in the study * Alcohol and drug abuse. * Peptic ulcer and duodenal ulcer in history. * Obesity, body mass index (BMI) ≥40 kg / m2 * Intake of Trimetazidine MB and its analogues for 3 months. before inclusion in research. * The presence of any disease that, according to the doctor, prevents the inclusion of the patient in the study. * unable to understand study instructions * with considerable illness in the musculoskeletal system or with physical disability, which complicates exercise training
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Fibrillation Recurrence | From RFA to 3 months | Number of participants with reccurrence of atrial fibrillation after RFA |
Participant flow
Pre-assignment details
There were no significant study events
Participants by arm
| Arm | Count |
|---|---|
| Physical Training Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)
Physical training program | 24 |
| Trimetazidine Treatment of trimetazidine in addition to standart therapy
Trimetazidine | 24 |
| Control Standard follow-up at the participating heart center | 24 |
| Total | 72 |
Baseline characteristics
| Characteristic | Physical Training | Trimetazidine | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 57.0 years STANDARD_DEVIATION 8.5 | 56.4 years STANDARD_DEVIATION 8.1 | 55.0 years STANDARD_DEVIATION 9.8 | 56.1 years STANDARD_DEVIATION 8.8 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 24 Participants | 24 Participants | 24 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Primary
Atrial Fibrillation Recurrence
Number of participants with reccurrence of atrial fibrillation after RFA
Time frame: From RFA to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Physical Training | Atrial Fibrillation Recurrence | 2 Participants |
| Trimetazidine | Atrial Fibrillation Recurrence | 3 Participants |
| Control | Atrial Fibrillation Recurrence | 7 Participants |
Primary
Atrial Fibrillation Recurrence
Number of participants with recurrence of atrial fibrillation after RFA
Time frame: From 3 months to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Physical Training | Atrial Fibrillation Recurrence | 1 Participants |
| Trimetazidine | Atrial Fibrillation Recurrence | 2 Participants |
| Control | Atrial Fibrillation Recurrence | 4 Participants |
Primary
Atrial Fibrillation Recurrence
Number of participants with recurrence of atrial fibrillation after RFA
Time frame: From 6 months to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Physical Training | Atrial Fibrillation Recurrence | 6 Participants |
| Trimetazidine | Atrial Fibrillation Recurrence | 6 Participants |
| Control | Atrial Fibrillation Recurrence | 9 Participants |