Efficacy of Personalized Exercise Program and Trimetazidine in Rehabilitation of Patients After RFA of AF

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation Paroxysmal
• Intervention / Treatment: Other: Physical training program; Drug: Trimetazidine

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical training; Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)	Other: Physical training program
Experimental: Trimetazidine; Treatment of trimetazidine in addition to standart therapy	Drug: Trimetazidine; Other Names: fatty acids beta-oxidation inhibitor
No Intervention: Control; Standard follow-up at the participating heart center

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Research Center for Preventive Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: rehabilitation; radiofrequency ablation; atrial fibrillation; physical training
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Vasodilator Agents; Trimetazidine
• Other Study ID Numbers: PTAF02-02/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: study protocol
• IPD Sharing Time Frame: until December 2020
• IPD Sharing Access Criteria: study protocol will be available upon request
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No