Atrial Fibrillation Paroxysmal Clinical Trial
Official title:
Clinical Efficacy of Personalized Exercise Program and an Inhibitor of Fatty Acid β-oxidation in Rehabilitation of Patients With Atrial Fibrillation After Primary Radiofrequency Ablation of Pulmonary Venous Orifices
NCT number | NCT04511520 |
Other study ID # | PTAF02-02/13 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2013 |
Est. completion date | April 2017 |
Verified date | May 2021 |
Source | National Medical Research Center for Therapy and Preventive Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | April 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 30 Years to 70 Years |
Eligibility | 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 ??. ??. ??.) - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
National Research Center for Preventive Medicine |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Atrial Fibrillation Recurrence | Number of participants with reccurrence of atrial fibrillation after RFA | From RFA to 3 months | |
Primary | Atrial Fibrillation Recurrence | Number of participants with recurrence of atrial fibrillation after RFA | From 3 months to 6 months | |
Primary | Atrial Fibrillation Recurrence | Number of participants with recurrence of atrial fibrillation after RFA | From 6 months to 12 months |
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