Upstream-therapy by Telmisartan and Amlodipine Combination for Improvement of Left Atrial Mechanical Function After Pulmonary Vein Antrum Isolation
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Primary Endpoint
- Left Atrial Pressure Load
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- — to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Therapy
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
Intervention: Telmisartan 80 mg and amlodipine 5 mg (Drug)
Placebo
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
Intervention: Placebo (for telmisartan and amlodipine) (Drug)
Outcomes
Primary Outcomes
Left Atrial Pressure Load
Time Frame: 7 days
Mean left atrial pressure (MLAP, mm Hg).
Pulmonary Circulation Pressure Load
Time Frame: 7 days
Right ventricular systolic pressure (RVSP, mm Hg).
Left Atrial Reservoir Function
Time Frame: 7 days
Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.
Pulmonary Vein Flow Emptying
Time Frame: 7 days
S/D ratio of right superior pulmonary vein flow
Retrograde Flow in Pulmonary Veins
Time Frame: 7 days
Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)
Left Atrial Dimensions
Time Frame: 7 days
Left atrial antero-posterior diameter (LAD, cm)
Active Emptying of Left Atrium
Time Frame: 7 days
Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).
Left Atrial Contractility
Time Frame: 7 days
Left atrial active emptying fraction (LAAEF, %)
Passive Emptying of Left Atrium
Time Frame: 7 days
Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).
Diastolic Function
Time Frame: 7 days
E/A ratio of transmitral flow
Isovolumic Relaxation
Time Frame: 7 days
Left ventricular isovolumic relaxation time (IVRT, ms).
Secondary Outcomes
- Quality of Life(7 days)
- Exercise Tolerance(7 days)
Investigators
Sergey Mamchur
Head of Department of Cardiovascular Disorders Diagnosis
Research Institute for Complex Problems of Cardiovascular Diseases, Russia