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OpenTrials
Completed

NCT Number: NCT02927223

Atropine in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

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.

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University

Nashville, Tennessee, 37027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atropine

Drug

Exercise treadmill test

Procedure

Primary outcomes

  1. Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery)

    Time frame: 20 minutes during exercise

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

Pretreatment With Atropine to Reduce Exercise-triggered Ventricular Ectopy in Patients With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 6, 2016
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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