Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation

Atrial Fibrillation Clinical Trial

Official title:

Upstream-therapy by Telmisartan and Amlodipine Combination for Improvement of Left Atrial Mechanical Function After Pulmonary Vein Antrum Isolation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734355
• Other study ID #: 0546-2015-0013
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2016
• Last updated: April 5, 2016
• Start date: November 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: The Federal Agency for Scientific Organizations
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Telmisartan 80 mg and amlodipine 5 mg

• Placebo (for telmisartan and amlodipine)
Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute for Complex Problems of Cardiovascular Diseases, Russia

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Passive emptying of left atrium	Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).	7 days	No
Primary	Active emptying of left atrium	Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).	7 days	No
Primary	Left atrial reservoir function	Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.	7 days	No
Primary	Diastolic function	Peak velocities of E and A phases (peak E and peak A, mm/s), and E/A ratio.	7 days	No
Primary	Isovolumic relaxation	Left ventricular isovolumic relaxation time (IVRT, ms).	7 days	No
Primary	Systolic and early diastolic pulmonary veins emptying	Velocity time integral of right superior pulmonary vein flow during left ventricular systole (VTI S, cm/s), left ventricular early filling (VTI D, cm/s), and S/D ratio.	7 days	No
Primary	Retrograde flow in pulmonary veins	Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm/s) and its duration (Ar dur, ms).	7 days	No
Primary	Left atrial contractility	Left atrial emptying fraction by Simpson biplane formula (LAEF, %); left atrial active emptying fraction (LAAEF, %).	7 days	No
Primary	Left atrial dimensions	Left atrial antero-posterior diameter (LAD, cm); left atrial volume (LAV, ml).	7 days	No
Primary	Left atrial pressure load	Mean left atrial pressure (MLAP, mm Hg).	7 days	No
Primary	Pulmonary circulation pressure load	Mean pulmonary artery pressure (MPAP, mm Hg), and right ventricular systolic pressure (RVSP, mm Hg).	7 days	No
Secondary	Quality of Life	The score of 8 parameters of 36-Item Short Form Health Survey (SF-36): Physical functioning; Role limitations due to physical health; Role limitations due to emotional problems; Energy/fatigue; Emotional well-being; Social functioning; Pain; General health.	7 days	No
Secondary	Exercise tolerance	six-minute walk distance in meters	7 days	No