N/A
N=72
Efficacy of Personalized Exercise Program and Trimetazidine in Rehabilitation of Patients After RFA of AF
Atrial Fibrillation Paroxysmal
Bottom Line
View on ClinicalTrials.gov: NCT04511520 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Atrial Fibrillation Recurrence — 2; 3; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical training program (Other); Trimetazidine (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Male
- Sponsor
- National Research Center for Preventive Medicine
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Atrial Fibrillation Recurrence |
6; 6; 9 | — |
| PRIMARY Atrial Fibrillation Recurrence |
6; 6; 9 | — |
| PRIMARY Atrial Fibrillation Recurrence |
6; 6; 9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04511520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.