Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Telmisartan 80 mg and amlodipine 5 mg
Placebo (for telmisartan and amlodipine)
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation, catheter ablation, left atrium, mechanical function, contractility
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Therapy
Placebo
Arm Description
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
Outcomes
Primary Outcome Measures
Passive Emptying of Left Atrium
Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).
Active Emptying of Left Atrium
Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).
Left Atrial Reservoir Function
Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.
Diastolic Function
E/A ratio of transmitral flow
Isovolumic Relaxation
Left ventricular isovolumic relaxation time (IVRT, ms).
Pulmonary Vein Flow Emptying
S/D ratio of right superior pulmonary vein flow
Retrograde Flow in Pulmonary Veins
Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)
Left Atrial Contractility
Left atrial active emptying fraction (LAAEF, %)
Left Atrial Dimensions
Left atrial antero-posterior diameter (LAD, cm)
Left Atrial Pressure Load
Mean left atrial pressure (MLAP, mm Hg).
Pulmonary Circulation Pressure Load
Right ventricular systolic pressure (RVSP, mm Hg).
Secondary Outcome Measures
Quality of Life
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).
Exercise Tolerance
six-minute walk distance in meters
Full Information
NCT ID
NCT02734355
First Posted
March 30, 2016
Last Updated
February 1, 2017
Sponsor
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
1. Study Identification
Unique Protocol Identification Number
NCT02734355
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, catheter ablation, left atrium, mechanical function, contractility
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapy
Arm Type
Active Comparator
Arm Description
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
Intervention Type
Drug
Intervention Name(s)
Telmisartan 80 mg and amlodipine 5 mg
Other Intervention Name(s)
Twynsta
Intervention Type
Drug
Intervention Name(s)
Placebo (for telmisartan and amlodipine)
Intervention Description
Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet
Primary Outcome Measure Information:
Title
Passive Emptying of Left Atrium
Description
Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).
Time Frame
7 days
Title
Active Emptying of Left Atrium
Description
Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).
Time Frame
7 days
Title
Left Atrial Reservoir Function
Description
Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.
Time Frame
7 days
Title
Diastolic Function
Description
E/A ratio of transmitral flow
Time Frame
7 days
Title
Isovolumic Relaxation
Description
Left ventricular isovolumic relaxation time (IVRT, ms).
Time Frame
7 days
Title
Pulmonary Vein Flow Emptying
Description
S/D ratio of right superior pulmonary vein flow
Time Frame
7 days
Title
Retrograde Flow in Pulmonary Veins
Description
Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)
Time Frame
7 days
Title
Left Atrial Contractility
Description
Left atrial active emptying fraction (LAAEF, %)
Time Frame
7 days
Title
Left Atrial Dimensions
Description
Left atrial antero-posterior diameter (LAD, cm)
Time Frame
7 days
Title
Left Atrial Pressure Load
Description
Mean left atrial pressure (MLAP, mm Hg).
Time Frame
7 days
Title
Pulmonary Circulation Pressure Load
Description
Right ventricular systolic pressure (RVSP, mm Hg).
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Quality of Life
Description
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
Title
Exercise Tolerance
Description
six-minute walk distance in meters
Time Frame
7 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yevgeny V Grigoriev, M.D., Ph.D.
Organizational Affiliation
Research Institute for Complex Problems of Cardiovascular Diseases
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25541269
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.
Results Reference
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Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation
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