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

NCT04511520 | Completed Results

• 1 other identifier: PTAF02-02/13
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation Paroxysmal

Keywords

rehabilitation; atrial fibrillation; physical training; radiofrequency ablation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Physical training

EXPERIMENTAL

Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)

Other: Physical training program

Trimetazidine

EXPERIMENTAL

Treatment of trimetazidine in addition to standart therapy

Drug: Trimetazidine

Control

NO INTERVENTION

Standard follow-up at the participating heart center

Interventions

Physical training program OTHER

Physical training

Trimetazidine DRUG

Also known as: fatty acids beta-oxidation inhibitor

Trimetazidine

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• treated for atrial fibrillation with radiofrequency ablation
• cardiac disease
• providing written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Center for Preventive Medicine: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Trimetazidine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Maria Makhinova
• Organization: National medical research center for therapy and preventive medicine

longtimeaftertomorrow@gmail.com

+79104803524

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: August 13, 2020
• Study Start: July 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: June 9, 2021
• Results First Posted: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: until December 2020
• Access Criteria: study protocol will be available upon request