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Atropine in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Not Applicable
Completed
Conditions
Catecholaminergic Polymorphic Ventricular Tachycardia
Interventions
Procedure: Exercise treadmill test
Registration Number
NCT02927223
Lead Sponsor
Vanderbilt University
Brief Summary

To test the hypothesis that increasing the sinus node rate with atropine treatment prior to exercise will reduce exercise-triggered ventricular ectopy compared to baseline in patients with CPVT.

Detailed Description

This is a prospective cross-over trial that will enroll eligible patients with CPVT and perform a baseline treadmill exercise tolerance test (ETT) followed by a repeat treadmill ETT with I.V. atropine administered immediately prior to exercise. Atropine is a parasympathetic blocker and results in sinus tachycardia, which is expected to reduce the diastolic interval thereby reducing delayed after depolarizations and ventricular ectopy compared to baseline. Both ETTs will be performed on the same day with two hours of rest scheduled between ETTs. The primary analysis will be a paired comparison of the number of ventricular ectopic beats recorded during exercise (and recovery) at baseline and following pre-treatment with atropine. Secondary endpoints will include the presence of ventricular ectopy (yes/no), complex ventricular ectopy (couplets or greater, yes/no), and the number of runs of complex ventricular ectopy.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
6
Inclusion Criteria
  • Age >/= 6 years
  • Able to provide written informed consent
  • Clinical diagnosis of CPVT
  • Able to exercise on a treadmill
  • Successful completion of a minimum of 2 exercise stress tests without adverse events
Exclusion Criteria
  • Contraindication to treadmill stress testing according to Vanderbilt University Medical Center's clinical protocols (unstable angina, decompensated congestive heart failure, severe hypertension (≥ 170/90 mmHg), acute myocardial infarction (<4 days), moderate to severe aortic stenosis, acute pulmonary embolism, severe pulmonary hypertension, outflow tract obstruction, hypertrophic cardiomyopathy, left main coronary stenosis, left bundle branch block)
  • Females who are pregnant
  • In the judgement of the investigator, any clinically significant ongoing medical or surgical condition that might jeopardize the subject's safety or interfere with the conduct of the study

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Treadmill then Treadmill with AtropineExercise treadmill testPatients will undergo treadmill exercise at baseline, then Patients will undergo treadmill exercise after IV atropine
Treadmill then Treadmill with AtropineAtropinePatients will undergo treadmill exercise at baseline, then Patients will undergo treadmill exercise after IV atropine
Primary Outcome Measures
NameTimeMethod
Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery)20 minutes during exercise
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Vanderbilt University

🇺🇸

Nashville, Tennessee, United States

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