Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Status and phase

Completed

Phase 4

Conditions

Atrial Fibrillation

Treatments

Drug: Telmisartan 80 mg and amlodipine 5 mg

Drug: Placebo (for telmisartan and amlodipine)

Study type

Interventional

Funder types

Other

Identifiers

NCT02734355

0546-2015-0013

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

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.