Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, catheter ablation, left atrium, mechanical function, contractility
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.
Interventions
DRUGTelmisartan 80 mg and amlodipine 5 mg
DRUGPlacebo (for telmisartan and amlodipine)
Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet
Sponsors
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Circulation Pressure Load | 7 days | Right ventricular systolic pressure (RVSP, mm Hg). |
| Left Atrial Pressure Load | 7 days | Mean left atrial pressure (MLAP, mm Hg). |
| Pulmonary Vein Flow Emptying | 7 days | S/D ratio of right superior pulmonary vein flow |
| Passive Emptying of Left Atrium | 7 days | Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm). |
| Active Emptying of Left Atrium | 7 days | Velocity time integral of transmitral flow during atrial contraction (VTI A, cm). |
| Left Atrial Reservoir Function | 7 days | Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole. |
| Diastolic Function | 7 days | E/A ratio of transmitral flow |
| Isovolumic Relaxation | 7 days | Left ventricular isovolumic relaxation time (IVRT, ms). |
| Retrograde Flow in Pulmonary Veins | 7 days | Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm) |
| Left Atrial Contractility | 7 days | Left atrial active emptying fraction (LAAEF, %) |
| Left Atrial Dimensions | 7 days | Left atrial antero-posterior diameter (LAD, cm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 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). |
| Exercise Tolerance | 7 days | six-minute walk distance in meters |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Therapy Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
Telmisartan 80 mg and amlodipine 5 mg | 34 |
| Placebo Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
Placebo (for telmisartan and amlodipine): Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet | 30 |
| Total | 64 |
Baseline characteristics
| Characteristic | Therapy | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 5.7 | 54.1 years STANDARD_DEVIATION 6.2 | 53.1 years STANDARD_DEVIATION 6.7 |
| Region of Enrollment Russian Federation | 34 Participants | 30 Participants | 64 Participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Male | 22 Participants | 19 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 34 | 2 / 30 |
| serious Total, serious adverse events | 0 / 34 | 0 / 30 |
Outcome results
Primary
Active Emptying of Left Atrium
Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy | Active Emptying of Left Atrium | 7.4 cm | Standard Deviation 2.6 |
| Placebo | Active Emptying of Left Atrium | 5.4 cm | Standard Deviation 1.3 |
Primary
Diastolic Function
E/A ratio of transmitral flow
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy | Diastolic Function | 1.62 ratio | Standard Deviation 0.35 |
| Placebo | Diastolic Function | 2.64 ratio | Standard Deviation 0.63 |
Primary
Isovolumic Relaxation
Left ventricular isovolumic relaxation time (IVRT, ms).
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy | Isovolumic Relaxation | 117 ms | Standard Deviation 19 |
| Placebo | Isovolumic Relaxation | 98 ms | Standard Deviation 10 |
Primary
Left Atrial Contractility
Left atrial active emptying fraction (LAAEF, %)
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy | Left Atrial Contractility | 40 percentage of LA maximum volume | Standard Deviation 6.7 |
| Placebo | Left Atrial Contractility | 31.6 percentage of LA maximum volume | Standard Deviation 6.7 |
Primary
Left Atrial Dimensions
Left atrial antero-posterior diameter (LAD, cm)
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy | Left Atrial Dimensions | 3.9 cm | Standard Deviation 0.3 |
| Placebo | Left Atrial Dimensions | 4.1 cm | Standard Deviation 0.6 |
Primary
Left Atrial Pressure Load
Mean left atrial pressure (MLAP, mm Hg).
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy | Left Atrial Pressure Load | 9 mm Hg | Standard Deviation 3.1 |
| Placebo | Left Atrial Pressure Load | 13.8 mm Hg | Standard Deviation 2.9 |
Primary
Left Atrial Reservoir Function
Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy | Left Atrial Reservoir Function | 19.1 cm | Standard Deviation 3.5 |
| Placebo | Left Atrial Reservoir Function | 13.3 cm | Standard Deviation 3.2 |
Primary
Passive Emptying of Left Atrium
Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy | Passive Emptying of Left Atrium | 14.7 cm | Standard Deviation 4.4 |
| Placebo | Passive Emptying of Left Atrium | 20.9 cm | Standard Deviation 5.2 |
Primary
Pulmonary Circulation Pressure Load
Right ventricular systolic pressure (RVSP, mm Hg).
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy | Pulmonary Circulation Pressure Load | 16.7 mm Hg | Standard Deviation 9.6 |
| Placebo | Pulmonary Circulation Pressure Load | 31.6 mm Hg | Standard Deviation 14.4 |
Primary
Pulmonary Vein Flow Emptying
S/D ratio of right superior pulmonary vein flow
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy | Pulmonary Vein Flow Emptying | 1.3 ratio | Standard Deviation 0.39 |
| Placebo | Pulmonary Vein Flow Emptying | 1.46 ratio | Standard Deviation 0.37 |
Primary
Retrograde Flow in Pulmonary Veins
Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy | Retrograde Flow in Pulmonary Veins | 4.1 cm | Standard Deviation 1.4 |
| Placebo | Retrograde Flow in Pulmonary Veins | 1.5 cm | Standard Deviation 0.5 |
Secondary
Exercise Tolerance
six-minute walk distance in meters
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy | Exercise Tolerance | 403 m | Standard Deviation 27 |
| Placebo | Exercise Tolerance | 345 m | Standard Deviation 25 |
Secondary
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).
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy | Quality of Life | 92 units on a scale | Standard Deviation 4 |
| Placebo | Quality of Life | 85 units on a scale | Standard Deviation 5 |