Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation

Study Overview
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Brief Summary
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The objective of the study was to estimate the efficacy of telmisartan and amlodipine combination on the restoration of left atrial mechanical function after atrial fibrillation catheter ablation.

Detailed Description
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64 candidates to atrial fibrillation ablation were included in the study. Patients were randomly assigned to telmisartan/amlodipine combination in dose 80/5 mg (group I, n=34) or placebo (group II, n=30) taking daily for up to one week. Echocardiography was performed before the procedure, immediately after it, and after a week of therapy. The six-minute walk test and SF-36 questionnaire results were evaluated a day before the procedure and after a week of the therapy. The left ventricular end-diastolic pressure was invasively measured after transseptal puncture and before left atrial sheath removal.

Official Title
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Upstream-therapy by Telmisartan and Amlodipine Combination for Improvement of Left Atrial Mechanical Function After Pulmonary Vein Antrum Isolation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Telmisartan 80 mg and amlodipine 5 mg
* Drug: Placebo (for telmisartan and amlodipine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic (III-IV class by European Heart Rhythm Association scale) paroxysmal atrial fibrillation; Ineffective therapy by at least one of the class I or III antiarrhythmic drugs; Left atrial diameter 5 cm or less; Estimated catheter radiofrequency pulmonary vein antrum isolation; Signed informed consent. Exclusion Criteria: Intolerance/allergy or contraindications to telmisartan, amlodipine, warfarin or enoxaparin; Left atrial thrombosis; Age greater than 75 years; Severe (e.g. decompensation of vital functions) or acute (e.g. pneumonia) somatic conditions; Malignant growth in the hematogenic dissemination stage.

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Therapy<br>Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days | Drug: Telmisartan 80 mg and amlodipine 5 mg<br> <br> * Other names: Twynsta;|
| Placebo Comparator: Placebo<br>Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days | Drug: Placebo (for telmisartan and amlodipine)<br>* Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Passive Emptying of Left Atrium | Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm). | 7 days | 
| Active Emptying of Left Atrium | Velocity time integral of transmitral flow during atrial contraction (VTI A, cm). | 7 days | 
| Left Atrial Reservoir Function | Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole. | 7 days | 
| Diastolic Function | E/A ratio of transmitral flow | 7 days | 
| Isovolumic Relaxation | Left ventricular isovolumic relaxation time (IVRT, ms). | 7 days | 
| Pulmonary Vein Flow Emptying | S/D ratio of right superior pulmonary vein flow | 7 days | 
| Retrograde Flow in Pulmonary Veins | Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm) | 7 days | 
| Left Atrial Contractility | Left atrial active emptying fraction (LAAEF, %) | 7 days | 
| Left Atrial Dimensions | Left atrial antero-posterior diameter (LAD, cm) | 7 days | 
| Left Atrial Pressure Load | Mean left atrial pressure (MLAP, mm Hg). | 7 days | 
| Pulmonary Circulation Pressure Load | Right ventricular systolic pressure (RVSP, mm Hg). | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | The average of eight scores of 36-Item Short Form Health Survey (SF-36). In every case all of eight scores (which ranges from 0 to 100) was summarized, then the sum was divided by 8. Thus the outcome also ranges from 0 (worse outcome) to 100 (better outcome). | 7 days | 
| Exercise Tolerance | six-minute walk distance in meters | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, catheter ablation, left atrium, mechanical function, contractility