Premature Ventricular Contractions (PVCs) and Blood Pressure Control
NCT ID: NCT01833455
Last Updated: 2019-02-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2013-02-28
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willingness to participate in research
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Mohamed H Hamdan, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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UW-PVC-2012-0510
Identifier Type: -
Identifier Source: org_study_id
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