Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation

Phase 4

Completed

Interventions: Drug: Telmisartan 80 mg and amlodipine 5 mg
Drug: Placebo (for telmisartan and amlodipine)

Lead Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Therapy	Telmisartan 80 mg and amlodipine 5 mg	Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
Placebo	Placebo (for telmisartan and amlodipine)	Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Exercise Tolerance	7 days	six-minute walk distance in meters
Quality of Life	7 days	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).