Title
Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation
Upstream-therapy by Telmisartan and Amlodipine Combination for Improvement of Left Atrial Mechanical Function After Pulmonary Vein Antrum Isolation
Phase
Phase 4Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Atrial FibrillationIntervention/Treatment
amlodipine telmisartan ...Study Participants
64The 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.
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.
Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
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.
| Event Type | Organ System | Event Term | Therapy | Placebo |
|---|
Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).
Mean left atrial pressure (MLAP, mm Hg).
Right ventricular systolic pressure (RVSP, mm Hg).
Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).
Left atrial antero-posterior diameter (LAD, cm)
Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.
E/A ratio of transmitral flow
Left ventricular isovolumic relaxation time (IVRT, ms).
S/D ratio of right superior pulmonary vein flow
Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)
Left atrial active emptying fraction (LAAEF, %)
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).
six-minute walk distance in meters
