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
Sponsored by
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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
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
No
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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