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Atropine in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Primary Purpose

Catecholaminergic Polymorphic Ventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atropine
Exercise treadmill test
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Catecholaminergic Polymorphic Ventricular Tachycardia

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treadmill then Treadmill with Atropine

Arm Description

Patients will undergo treadmill exercise at baseline, then Patients will undergo treadmill exercise after IV atropine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 5, 2016
Last Updated
January 16, 2020
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT02927223
Brief Title
Atropine in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Official Title
Pretreatment With Atropine to Reduce Exercise-triggered Ventricular Ectopy in Patients With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catecholaminergic Polymorphic Ventricular Tachycardia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treadmill then Treadmill with Atropine
Arm Type
Experimental
Arm Description
Patients will undergo treadmill exercise at baseline, then Patients will undergo treadmill exercise after IV atropine
Intervention Type
Drug
Intervention Name(s)
Atropine
Intervention Type
Procedure
Intervention Name(s)
Exercise treadmill test
Primary Outcome Measure Information:
Title
Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery)
Time Frame
20 minutes during exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prince J Kannankeril, MD, MSCI
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32091590
Citation
Kannankeril PJ, Shoemaker MB, Gayle KA, Fountain D, Roden DM, Knollmann BC. Atropine-induced sinus tachycardia protects against exercise-induced ventricular arrhythmias in patients with catecholaminergic polymorphic ventricular tachycardia. Europace. 2020 Apr 1;22(4):643-648. doi: 10.1093/europace/euaa029.
Results Reference
derived

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Atropine in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

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