Trial Outcomes & Findings for Premature Ventricular Contractions (PVCs) and Blood Pressure Control (NCT NCT01833455)
NCT ID: NCT01833455
Last Updated: 2019-02-22
Results Overview
Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Baseline and 28 days
Results posted on
2019-02-22
Participant Flow
Participant milestones
| Measure |
PVC Suppression Then Placebo
This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
|
Placebo Then PVC Suppression
This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
Completed 1st Baseline
|
4
|
4
|
|
Overall Study
Completed 1st Intervention
|
3
|
4
|
|
Overall Study
Completed 2nd Baseline (Washout)
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
PVC Suppression Then Placebo
This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
|
Placebo Then PVC Suppression
This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Premature Ventricular Contractions (PVCs) and Blood Pressure Control
Baseline characteristics by cohort
| Measure |
PVC Suppression Then Placebo
n=4 Participants
This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
|
Placebo Then PVC Suppression
n=4 Participants
This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
PVC Burden
|
26 % of heartbeats
STANDARD_DEVIATION 13 • n=5 Participants
|
30 % of heartbeats
STANDARD_DEVIATION 13 • n=7 Participants
|
28 % of heartbeats
STANDARD_DEVIATION 12 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 28 daysPopulation: Mean arterial blood pressure values were not available at all time points for every patient. Data on subjects who completed the study is presented here and may not reflect changes seen in a larger population.
Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements.
Outcome measures
| Measure |
Change From Base 1 to PVC Suppression
n=3 Participants
This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
Change in BP values from baseline to PVC suppression in the group that received flecainide (PVC suppression) first.
|
Change From Base 2 to no PVC Suppression
n=3 Participants
This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
Change in BP values from 2nd baseline (washout) to PVC suppression in the group that received flecainide (PVC suppression) first.
|
Change From Base 1 to no PVC Suppression
n=4 Participants
This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
Change in BP values from first baseline to no PVC suppression in the group that received placebo (no PVC suppression) first.
|
Change From Base 2 to PVC Suppression
n=4 Participants
This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
Change in BP values from 2nd baseline (washout) to PVC suppression in the group that received placebo (no PVC suppression) first.
|
|---|---|---|---|---|
|
Change in Mean Arterial Pressure
|
2 mmHg
Standard Deviation 2
|
1 mmHg
Standard Deviation 4
|
3 mmHg
Standard Deviation 11
|
-4 mmHg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Baseline and 28 daysPopulation: SNA values were not obtained in many of the participants in various groups above due to technical difficulties. Data on subjects who underwent the measurement are presented here and may not reflect changes seen in a larger population.
Muscle sympathetic nerve activity was measured as number of bursts of neural activity per 100 heart beats.
Outcome measures
| Measure |
Change From Base 1 to PVC Suppression
n=1 Participants
This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
Change in BP values from baseline to PVC suppression in the group that received flecainide (PVC suppression) first.
|
Change From Base 2 to no PVC Suppression
n=1 Participants
This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
Change in BP values from 2nd baseline (washout) to PVC suppression in the group that received flecainide (PVC suppression) first.
|
Change From Base 1 to no PVC Suppression
n=1 Participants
This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
Change in BP values from first baseline to no PVC suppression in the group that received placebo (no PVC suppression) first.
|
Change From Base 2 to PVC Suppression
n=1 Participants
This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
Change in BP values from 2nd baseline (washout) to PVC suppression in the group that received placebo (no PVC suppression) first.
|
|---|---|---|---|---|
|
Change in Muscle Sympathetic Nerve Activity
|
1 bursts / 100 heartbeats
|
-10 bursts / 100 heartbeats
|
-3 bursts / 100 heartbeats
|
15 bursts / 100 heartbeats
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 28 daysPopulation: Arterial baroreflex gain values were not available at all time points. In one subject, gain could not be calculated because they were in bigeminy. Data on subjects who completed the study is presented here and may not reflect changes seen in a larger population.
Arterial baroreflex gain is calculated as slope of the relationship between cardiac cycle length and the corresponding change in systolic blood pressure.
Outcome measures
| Measure |
Change From Base 1 to PVC Suppression
n=3 Participants
This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
Change in BP values from baseline to PVC suppression in the group that received flecainide (PVC suppression) first.
|
Change From Base 2 to no PVC Suppression
n=3 Participants
This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
Change in BP values from 2nd baseline (washout) to PVC suppression in the group that received flecainide (PVC suppression) first.
|
Change From Base 1 to no PVC Suppression
n=4 Participants
This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
Change in BP values from first baseline to no PVC suppression in the group that received placebo (no PVC suppression) first.
|
Change From Base 2 to PVC Suppression
n=4 Participants
This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden.
PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden.
Change in BP values from 2nd baseline (washout) to PVC suppression in the group that received placebo (no PVC suppression) first.
|
|---|---|---|---|---|
|
Change in Baroreflex Gain
|
4 ms/mmHg
Standard Deviation 1
|
6 ms/mmHg
Standard Deviation 2
|
8 ms/mmHg
Standard Deviation 5
|
15 ms/mmHg
Standard Deviation 7
|
Adverse Events
Base 1 to PVC Suppression
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Base 2 to no PVC Suppression
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Base 1 to no PVC Suppression
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Base 2 to PVC Suppression
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place