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Atrial Fibrillation ParoxysmalNCT04511520

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

A study testing Physical training program and Trimetazidine in people with Atrial Fibrillation Paroxysmal, run by National Research Center for Preventive Medicine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 70 years, men only
Conditions the study is for
Atrial Fibrillation Paroxysmal
What is being tested?
Physical training program and Trimetazidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
No sites listed yet
Study dates
Jul 2013to Apr 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).
Show all 25Show fewer
  • 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

About this study

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

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.

Read the 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.

Being tested
Physical training program, Trimetazidine
Keywords
rehabilitation, atrial fibrillation, physical training, radiofrequency ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical training programOther

  • TrimetazidineDrug

    Also called fatty acids beta-oxidation inhibitor

Study groups in NCT04511520
Study groupRoleWhat they receive
Physical trainingExperimentalIntegrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of 6 months)
Receives: Other: Physical training program
TrimetazidineExperimentalTreatment of trimetazidine in addition to standart therapy
Receives: Drug: Trimetazidine
ControlNo interventionStandard follow-up at the participating heart center

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Atrial Fibrillation Recurrence

    Number of participants with reccurrence of atrial fibrillation after RFA

    Measured: From RFA to 3 months

  2. Atrial Fibrillation Recurrence

    Number of participants with recurrence of atrial fibrillation after RFA

    Measured: From 3 months to 6 months

  3. Atrial Fibrillation Recurrence

    Number of participants with recurrence of atrial fibrillation after RFA

    Measured: From 6 months to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2020
  2. Study startJul 2013
  3. Primary completionDec 2016
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04511520
Sponsor's protocol ID
PTAF02-02/13
Status last verified
May 2021
First submitted
10 Jun 2020
Last updated
9 Jun 2021
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: study protocol

Questions about this trial

What is this clinical trial studying?

A study testing Physical training program and Trimetazidine in people with Atrial Fibrillation Paroxysmal, run by National Research Center for Preventive Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atrial Fibrillation Recurrence (time frame: From RFA to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04511520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.

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