Atropine in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Catecholaminergic Polymorphic Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927223
• Other study ID #: VUMC-161398
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: February 2019

Study information

• Verified date: January 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catecholaminergic Polymorphic Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular

Intervention

Drug:
• Atropine

Procedure:
• Exercise treadmill test

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery)		20 minutes during exercise