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

Primary Purpose

Atrial Fibrillation Paroxysmal

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Physical training program

Trimetazidine

About this trial

This is an interventional prevention trial for Atrial Fibrillation Paroxysmal focused on measuring rehabilitation, atrial fibrillation, physical training, radiofrequency ablation

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Physical training

Trimetazidine

Control

Arm Description

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

Treatment of trimetazidine in addition to standart therapy

Standard follow-up at the participating heart center

Outcomes

Primary Outcome Measures

Atrial Fibrillation Recurrence

Number of participants with reccurrence of atrial fibrillation after RFA

Atrial Fibrillation Recurrence

Number of participants with recurrence of atrial fibrillation after RFA

Atrial Fibrillation Recurrence

Number of participants with recurrence of atrial fibrillation after RFA

Secondary Outcome Measures

Full Information

NCT ID

NCT04511520

First Posted

June 10, 2020

Last Updated

May 24, 2021

Sponsor

National Research Center for Preventive Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04511520

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

July 2013 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Research Center for Preventive Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation Paroxysmal

Keywords

rehabilitation, atrial fibrillation, physical training, radiofrequency ablation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physical training

Arm Type

Experimental

Arm Description

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

Arm Title

Trimetazidine

Arm Type

Experimental

Arm Description

Treatment of trimetazidine in addition to standart therapy

Arm Title

Control

Arm Type

No Intervention

Arm Description

Standard follow-up at the participating heart center

Intervention Type

Other

Intervention Name(s)

Physical training program

Intervention Type

Drug

Intervention Name(s)

Trimetazidine

Other Intervention Name(s)

fatty acids beta-oxidation inhibitor

Primary Outcome Measure Information:

Title

Atrial Fibrillation Recurrence

Description

Number of participants with reccurrence of atrial fibrillation after RFA

Time Frame

From RFA to 3 months

Title

Atrial Fibrillation Recurrence

Description

Number of participants with recurrence of atrial fibrillation after RFA

Time Frame

From 3 months to 6 months

Title

Atrial Fibrillation Recurrence

Description

Number of participants with recurrence of atrial fibrillation after RFA

Time Frame

From 6 months to 12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

study protocol

IPD Sharing Time Frame

until December 2020

IPD Sharing Access Criteria

study protocol will be available upon request

Learn more about this trial

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

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