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
| Type | Name | Description |
|---|---|---|
| DRUG | Telmisartan 80 mg and amlodipine 5 mg | |
| DRUG | Placebo (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.