Clinical trial NCT02734355: Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation
Official title: Upstream-therapy by Telmisartan and Amlodipine Combination for Improvement of Left Atrial Mechanical Function After Pulmonary Vein Antrum Isolation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
catheter ablation
left atrium
mechanical function
contractility
Lead sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 64
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Passive Emptying of Left Atrium
timeFrame: 7 days
measure: Active Emptying of Left Atrium
timeFrame: 7 days
measure: Left Atrial Reservoir Function
timeFrame: 7 days
measure: Diastolic Function
timeFrame: 7 days
measure: Isovolumic Relaxation
timeFrame: 7 days
measure: Pulmonary Vein Flow Emptying
timeFrame: 7 days
measure: Retrograde Flow in Pulmonary Veins
timeFrame: 7 days
measure: Left Atrial Contractility
timeFrame: 7 days
measure: Left Atrial Dimensions
timeFrame: 7 days
measure: Left Atrial Pressure Load
timeFrame: 7 days
measure: Pulmonary Circulation Pressure Load
timeFrame: 7 days
Secondary outcomes:
measure: Quality of Life
timeFrame: 7 days
measure: Exercise Tolerance
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Research Institute for Complex Problems of Cardiovascular Diseases
name: Yevgeny V Grigoriev, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Mamchur S, Mamchur I, Khomenko E, Kokov A, Bokhan N, Sherbinina D. Mechanical function of left atrium and pulmonary vein sleeves before and after their antrum isolation. Medicina (Kaunas). 2014;50(6):353-9. doi: 10.1016/j.medici.2014.11.008. Epub 2014 Nov 28.