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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

Brief Summary:
The purpose of this study is to determine if reduction in premature ventricular contraction (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC suppression in a randomized, double-blinded, crossover fashion.

Condition or disease Intervention/treatment Phase
Ventricular Premature Complexes Blood Pressure Drug: PVC Suppression using Flecainide Drug: No PVC Suppression using Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of PVC Suppression on Blood Pressure Control in Patients With Frequent PVCs
Study Start Date : February 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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.
Drug: PVC Suppression using Flecainide
Flecainide will be administered to result in a reduction in PVC burden.
Other Name: Tambocor

Drug: No PVC Suppression using Placebo
Placebo (sugar pills) will be given to result in no alteration in PVC burden.

Placebo Comparator: 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.
Drug: PVC Suppression using Flecainide
Flecainide will be administered to result in a reduction in PVC burden.
Other Name: Tambocor

Drug: No PVC Suppression using Placebo
Placebo (sugar pills) will be given to result in no alteration in PVC burden.




Primary Outcome Measures :
  1. Change in Mean Arterial Pressure [ Time Frame: Baseline and 28 days ]
    Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements.


Secondary Outcome Measures :
  1. Change in Muscle Sympathetic Nerve Activity [ Time Frame: Baseline and 28 days ]
    Muscle sympathetic nerve activity was measured as number of bursts of neural activity per 100 heart beats.


Other Outcome Measures:
  1. Change in Baroreflex Gain [ Time Frame: Baseline and 28 days ]
    Arterial baroreflex gain is calculated as slope of the relationship between cardiac cycle length and the corresponding change in systolic blood pressure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Frequent symptomatic premature ventricular contractions (PVCs) (>10% of total QRSs on a 24-hour Holter)
  • Willingness to participate in research

Exclusion Criteria:

  • Age > 65 years old
  • Pacemaker implantation
  • Implantable cardioverter defibrillator implantation requiring pacing
  • Sick sinus syndrome
  • Atrio-ventricular (AV) block
  • Left ventricular dysfunction defined as left ventricular ejection fraction < 50%
  • History of myocardial infarction or coronary artery disease
  • Severe left ventricular hypertrophy (wall thickness > 1.5 cm by echocardiography performed within 3 months from enrollment)
  • Severe liver dysfunction
  • Creatinine clearance of 35 mL/min/1.73 square meters or less
  • Pregnancy
  • Known hypersensitivity to the drug
  • QRS duration > 120 ms
  • Recent change in blood pressure medication within 30 days of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833455


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Mohamed H Hamdan, MD, MBA University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01833455    
Other Study ID Numbers: UW-PVC-2012-0510
First Posted: April 16, 2013    Key Record Dates
Results First Posted: February 22, 2019
Last Update Posted: February 22, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Premature Birth
Ventricular Premature Complexes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Flecainide
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action