Clinical Trials Directory

Trials / Completed

CompletedNCT02734355

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
64 (actual)
Sponsor
Research Institute for Complex Problems of Cardiovascular Diseases, Russia · Academic / Other
Sex
All
Age
75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGTelmisartan 80 mg and amlodipine 5 mg
DRUGPlacebo (for telmisartan and amlodipine)Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet

Timeline

Start date
2015-11-01
Primary completion
2016-01-01
Completion
2016-02-01
First posted
2016-04-12
Last updated
2017-03-22
Results posted
2017-03-22

Source: ClinicalTrials.gov record NCT02734355. Inclusion in this directory is not an endorsement.