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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

Tracking Information
First Submitted Date  ICMJE April 9, 2013
First Posted Date  ICMJE April 16, 2013
Results First Submitted Date  ICMJE August 21, 2018
Results First Posted Date  ICMJE February 22, 2019
Last Update Posted Date February 22, 2019
Study Start Date  ICMJE February 2013
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2013)
Change in Blood Pressure [ Time Frame: Baseline and 28 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2013)
Change in Muscle Sympathetic Nerve Activity [ Time Frame: Baseline and 28 days ]
Current Other Pre-specified Outcome Measures
 (submitted: January 29, 2019)
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.
Original Other Pre-specified Outcome Measures
 (submitted: April 12, 2013)
Change in Baroreflex Gain [ Time Frame: Baseline and 28 days ]
 
Descriptive Information
Brief Title  ICMJE Premature Ventricular Contractions (PVCs) and Blood Pressure Control
Official Title  ICMJE The Effects of PVC Suppression on Blood Pressure Control in Patients With Frequent PVCs
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Ventricular Premature Complexes
  • Blood Pressure
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: PVC Suppression using Flecainide
    • Drug: No PVC Suppression using Placebo
  • 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.
    Interventions:
    • Drug: PVC Suppression using Flecainide
    • Drug: No PVC Suppression using Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 7, 2018)
8
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2013)
66
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01833455
Other Study ID Numbers  ICMJE UW-PVC-2012-0510
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed H Hamdan, MD, MBA University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP