Trial Outcomes & Findings for Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation (NCT NCT02734355)
NCT ID: NCT02734355
Last Updated: 2017-03-22
Results Overview
Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
7 days
Results posted on
2017-03-22
Participant Flow
Participant milestones
| Measure |
Therapy
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
30
|
|
Overall Study
COMPLETED
|
34
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation
Baseline characteristics by cohort
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
Telmisartan 80 mg and amlodipine 5 mg
|
Placebo
n=30 Participants
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
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
54.1 years
STANDARD_DEVIATION 6.2 • n=107 Participants
|
53.1 years
STANDARD_DEVIATION 6.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Region of Enrollment
Russian Federation
|
34 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7 daysVelocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).
Outcome measures
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 Participants
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Passive Emptying of Left Atrium
|
14.7 cm
Standard Deviation 4.4
|
20.9 cm
Standard Deviation 5.2
|
PRIMARY outcome
Timeframe: 7 daysVelocity time integral of transmitral flow during atrial contraction (VTI A, cm).
Outcome measures
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 Participants
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Active Emptying of Left Atrium
|
7.4 cm
Standard Deviation 2.6
|
5.4 cm
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: 7 daysVelocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.
Outcome measures
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 Participants
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Left Atrial Reservoir Function
|
19.1 cm
Standard Deviation 3.5
|
13.3 cm
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: 7 daysE/A ratio of transmitral flow
Outcome measures
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 Participants
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Diastolic Function
|
1.62 ratio
Standard Deviation 0.35
|
2.64 ratio
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: 7 daysLeft ventricular isovolumic relaxation time (IVRT, ms).
Outcome measures
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 Participants
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Isovolumic Relaxation
|
117 ms
Standard Deviation 19
|
98 ms
Standard Deviation 10
|
PRIMARY outcome
Timeframe: 7 daysS/D ratio of right superior pulmonary vein flow
Outcome measures
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 Participants
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Pulmonary Vein Flow Emptying
|
1.3 ratio
Standard Deviation 0.39
|
1.46 ratio
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: 7 daysVelocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)
Outcome measures
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 Participants
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Retrograde Flow in Pulmonary Veins
|
4.1 cm
Standard Deviation 1.4
|
1.5 cm
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: 7 daysLeft atrial active emptying fraction (LAAEF, %)
Outcome measures
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 Participants
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Left Atrial Contractility
|
40 percentage of LA maximum volume
Standard Deviation 6.7
|
31.6 percentage of LA maximum volume
Standard Deviation 6.7
|
PRIMARY outcome
Timeframe: 7 daysLeft atrial antero-posterior diameter (LAD, cm)
Outcome measures
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 Participants
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Left Atrial Dimensions
|
3.9 cm
Standard Deviation 0.3
|
4.1 cm
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: 7 daysMean left atrial pressure (MLAP, mm Hg).
Outcome measures
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 Participants
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Left Atrial Pressure Load
|
9 mm Hg
Standard Deviation 3.1
|
13.8 mm Hg
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: 7 daysRight ventricular systolic pressure (RVSP, mm Hg).
Outcome measures
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 Participants
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Pulmonary Circulation Pressure Load
|
16.7 mm Hg
Standard Deviation 9.6
|
31.6 mm Hg
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: 7 daysThe 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).
Outcome measures
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 Participants
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Quality of Life
|
92 units on a scale
Standard Deviation 4
|
85 units on a scale
Standard Deviation 5
|
SECONDARY outcome
Timeframe: 7 dayssix-minute walk distance in meters
Outcome measures
| Measure |
Therapy
n=34 Participants
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 Participants
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Exercise Tolerance
|
403 m
Standard Deviation 27
|
345 m
Standard Deviation 25
|
Adverse Events
Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Therapy
n=34 participants at risk
Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
|
Placebo
n=30 participants at risk
Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
|
|---|---|---|
|
Cardiac disorders
Drug-induced hypotension
|
5.9%
2/34 • Number of events 2 • 7 days
|
3.3%
1/30 • Number of events 1 • 7 days
|
|
Blood and lymphatic system disorders
Swelling of lower leg
|
2.9%
1/34 • Number of events 1 • 7 days
|
3.3%
1/30 • Number of events 1 • 7 days
|
Additional Information
Dr. Sergey Mamchur
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Phone: +73842643308
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place