Status:
COMPLETED
Efficacy of Personalized Exercise Program and Trimetazidine in Rehabilitation of Patients After RFA of AF
Lead Sponsor:
National Research Center for Preventive Medicine
Conditions:
Atrial Fibrillation Paroxysmal
Eligibility:
MALE
30-70 years
Phase:
NA
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 (...
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 ...
Eligibility Criteria
Inclusion
- treated for atrial fibrillation with radiofrequency ablation
- cardiac disease
- providing written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04511520
Start Date
July 1 2013
End Date
April 1 2017
Last Update
June 9 2021
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