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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy | Active Comparator | Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days |
|
| Placebo | Placebo Comparator | Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan 80 mg and amlodipine 5 mg | Drug |
|
| |
| Placebo (for telmisartan and amlodipine) |
| Measure | Description | Time Frame |
|---|---|---|
| Passive Emptying of Left Atrium | Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm). | 7 days |
| Active Emptying of Left Atrium | Velocity time integral of transmitral flow during atrial contraction (VTI A, cm). | 7 days |
| Left Atrial Reservoir Function | Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole. | 7 days |
| Diastolic Function | E/A ratio of transmitral flow | 7 days |
| Isovolumic Relaxation | Left ventricular isovolumic relaxation time (IVRT, ms). | 7 days |
| Pulmonary Vein Flow Emptying | S/D ratio of right superior pulmonary vein flow | 7 days |
| Retrograde Flow in Pulmonary Veins | Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm) | 7 days |
| Left Atrial Contractility | Left atrial active emptying fraction (LAAEF, %) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 7 days |
| Exercise Tolerance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yevgeny V Grigoriev, M.D., Ph.D. | Research Institute for Complex Problems of Cardiovascular Diseases | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25541269 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapy | Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days |
| FG001 | Placebo | Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapy | Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days Telmisartan 80 mg and amlodipine 5 mg |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Passive Emptying of Left Atrium | Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm). | Posted | Mean | Standard Deviation | cm | 7 days |
|
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Therapy | Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug-induced hypotension | Cardiac disorders | SNOMED CT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sergey Mamchur | Research Institute for Complex Problems of Cardiovascular Diseases, Russia | +73842643308 | reception@kemcardio.ru |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| C548840 | telmisartan amlodipine combination |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet |
|
| Left Atrial Dimensions | Left atrial antero-posterior diameter (LAD, cm) | 7 days |
| Left Atrial Pressure Load | Mean left atrial pressure (MLAP, mm Hg). | 7 days |
| Pulmonary Circulation Pressure Load | Right ventricular systolic pressure (RVSP, mm Hg). | 7 days |
six-minute walk distance in meters |
| 7 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Active Emptying of Left Atrium | Velocity time integral of transmitral flow during atrial contraction (VTI A, cm). | Posted | Mean | Standard Deviation | cm | 7 days |
|
|
|
| Primary | Left Atrial Reservoir Function | Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole. | Posted | Mean | Standard Deviation | cm | 7 days |
|
|
|
| Primary | Diastolic Function | E/A ratio of transmitral flow | Posted | Mean | Standard Deviation | ratio | 7 days |
|
|
|
| Primary | Isovolumic Relaxation | Left ventricular isovolumic relaxation time (IVRT, ms). | Posted | Mean | Standard Deviation | ms | 7 days |
|
|
|
| Primary | Pulmonary Vein Flow Emptying | S/D ratio of right superior pulmonary vein flow | Posted | Mean | Standard Deviation | ratio | 7 days |
|
|
|
| Primary | Retrograde Flow in Pulmonary Veins | Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm) | Posted | Mean | Standard Deviation | cm | 7 days |
|
|
|
| Primary | Left Atrial Contractility | Left atrial active emptying fraction (LAAEF, %) | Posted | Mean | Standard Deviation | percentage of LA maximum volume | 7 days |
|
|
|
| Primary | Left Atrial Dimensions | Left atrial antero-posterior diameter (LAD, cm) | Posted | Mean | Standard Deviation | cm | 7 days |
|
|
|
| Primary | Left Atrial Pressure Load | Mean left atrial pressure (MLAP, mm Hg). | Posted | Mean | Standard Deviation | mm Hg | 7 days |
|
|
|
| Primary | Pulmonary Circulation Pressure Load | Right ventricular systolic pressure (RVSP, mm Hg). | Posted | Mean | Standard Deviation | mm Hg | 7 days |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 7 days |
|
|
|
| Secondary | Exercise Tolerance | six-minute walk distance in meters | Posted | Mean | Standard Deviation | m | 7 days |
|
|
|
| 0 |
| 34 |
| 3 |
| 34 |
| EG001 | Placebo | Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days | 0 | 30 | 2 | 30 |
| Swelling of lower leg | Blood and lymphatic system disorders | SNOMED CT | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |