Telmisartan 80 mg and amlodipine 5 mg
DrugOther names: Twynsta
NCT Number: NCT02734355
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.
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Notify MeUp to 75 year
All sexes
Interventional
Phase 4
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Twynsta
Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet
Time frame: 7 days
Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).
Time frame: 7 days
Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).
Time frame: 7 days
Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.
Time frame: 7 days
E/A ratio of transmitral flow
Time frame: 7 days
Left ventricular isovolumic relaxation time (IVRT, ms).
Time frame: 7 days
S/D ratio of right superior pulmonary vein flow
Time frame: 7 days
Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)
Time frame: 7 days
Left atrial active emptying fraction (LAAEF, %)
Time frame: 7 days
Left atrial antero-posterior diameter (LAD, cm)
Time frame: 7 days
Mean left atrial pressure (MLAP, mm Hg).
Time frame: 7 days
Right ventricular systolic pressure (RVSP, mm Hg).
Time frame: 7 days
The average of eight scores of 36-Item Short Form Health Survey (SF-36). In every case all of eight scores (which ranges from 0 to 100) was summarized, then the sum was divided by 8. Thus the outcome also ranges from 0 (worse outcome) to 100 (better outcome).
Time frame: 7 days
six-minute walk distance in meters
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Other
Upstream-therapy by Telmisartan and Amlodipine Combination for Improvement of Left Atrial Mechanical Function After Pulmonary Vein Antrum Isolation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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