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Premature Ventricular Contractions (PVCs) and Blood Pressure Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01833455
Recruitment Status : Terminated (Insufficient enrollment.)
First Posted : April 16, 2013
Results First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Ventricular Premature Complexes
Blood Pressure
Interventions Drug: PVC Suppression using Flecainide
Drug: No PVC Suppression using Placebo
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PVC Suppression Then Placebo Placebo Then PVC Suppression
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 4 4
Completed 1st Baseline 4 4
Completed 1st Intervention 3 4
Completed 2nd Baseline (Washout) 3 4
Completed 3 4
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title PVC Suppression Then Placebo Placebo Then PVC Suppression Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
4
 100.0%
8
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Female
4
 100.0%
0
   0.0%
4
  50.0%
Male
0
   0.0%
4
 100.0%
4
  50.0%
PVC Burden  
Mean (Standard Deviation)
Unit of measure:  % of heartbeats
Number Analyzed 4 participants 4 participants 8 participants
26  (13) 30  (13) 28  (12)
1.Primary Outcome
Title Change in Mean Arterial Pressure
Hide Description Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements.
Time Frame Baseline and 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Change From Base 1 to PVC Suppression Change From Base 2 to no PVC Suppression Change From Base 1 to no PVC Suppression Change From Base 2 to PVC Suppression
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 3 3 4 4
Mean (Standard Deviation)
Unit of Measure: mmHg
2  (2) 1  (4) 3  (11) -4  (8)
2.Secondary Outcome
Title Change in Muscle Sympathetic Nerve Activity
Hide Description Muscle sympathetic nerve activity was measured as number of bursts of neural activity per 100 heart beats.
Time Frame Baseline and 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Change From Base 1 to PVC Suppression Change From Base 2 to no PVC Suppression Change From Base 1 to no PVC Suppression Change From Base 2 to PVC Suppression
Hide Arm/Group Description:

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 SNA values from baseline to PVC suppression in the group that received flecainide (PVC suppression) first.

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 SNA values from 2nd baseline (washout) to PVC suppression in the group that received flecainide (PVC suppression) first.

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 SNA values from first baseline to no PVC suppression in the group that received placebo (no PVC suppression) first.

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 SNA values from 2nd baseline (washout) to PVC suppression in the group that received placebo (no PVC suppression) first.

Overall Number of Participants Analyzed 1 1 1 1
Measure Type: Number
Unit of Measure: bursts / 100 heartbeats
1 -10 -3 15
3.Other Pre-specified Outcome
Title Change in Baroreflex Gain
Hide Description Arterial baroreflex gain is calculated as slope of the relationship between cardiac cycle length and the corresponding change in systolic blood pressure.
Time Frame Baseline and 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Change From Base 1 to PVC Suppression Change From Base 2 to no PVC Suppression Change From Base 1 to no PVC Suppression Change From Base 2 to PVC Suppression
Hide Arm/Group Description:

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 baroreflex gain values from baseline to PVC suppression in the group that received flecainide (PVC suppression) first.

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 baroreflex gain values from 2nd baseline (washout) to PVC suppression in the group that received flecainide (PVC suppression) first.

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 baroreflex gain values from first baseline to no PVC suppression in the group that received placebo (no PVC suppression) first.

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 baroreflex gain values from 2nd baseline (washout) to PVC suppression in the group that received placebo (no PVC suppression) first.

Overall Number of Participants Analyzed 3 3 4 4
Mean (Standard Deviation)
Unit of Measure: ms/mmHg
4  (1) 6  (2) 8  (5) 15  (7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Base 1 to PVC Suppression Base 2 to no PVC Suppression Base 1 to no PVC Suppression Base 2 to PVC Suppression
Hide Arm/Group Description

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.

Adverse events during baseline to PVC suppression in the group that received flecainide (PVC suppression) first.

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.

Adverse events during 2nd baseline (washout) to PVC suppression in the group that received flecainide (PVC suppression) first.

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.

Adverse events during first baseline to no PVC suppression in the group that received placebo (no PVC suppression) first.

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.

Adverse events during 2nd baseline (washout) to PVC suppression in the group that received placebo (no PVC suppression) first.

All-Cause Mortality
Base 1 to PVC Suppression Base 2 to no PVC Suppression Base 1 to no PVC Suppression Base 2 to PVC Suppression
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
Base 1 to PVC Suppression Base 2 to no PVC Suppression Base 1 to no PVC Suppression Base 2 to PVC Suppression
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Base 1 to PVC Suppression Base 2 to no PVC Suppression Base 1 to no PVC Suppression Base 2 to PVC Suppression
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
This study was terminated prematurely due to a loss of staff available to make the technical measurements involved. The small number of data points available lead us to conclude the data is uninterpretable.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephen Wasmund, PhD
Organization: University of Wisconsin
Phone: 801-587-3740
EMail: stephen.wasmund@carma.utah.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01833455    
Other Study ID Numbers: UW-PVC-2012-0510
First Submitted: April 9, 2013
First Posted: April 16, 2013
Results First Submitted: August 21, 2018
Results First Posted: February 22, 2019
Last Update Posted: February 22, 2019