Atropine in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

• Sponsor: Vanderbilt University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02927223
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 28
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Catecholaminergic Polymorphic Ventricular Tachycardia	Drug: Atropine; Procedure: Exercise treadmill test	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Pretreatment With Atropine to Reduce Exercise-triggered Ventricular Ectopy in Patients With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
• Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Feb 1, 2019
• Actual Study Completion Date: Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treadmill then Treadmill with Atropine Patients will undergo treadmill exercise at baseline, then Patients will undergo treadmill exercise after IV atropine	Drug: Atropine; Procedure: Exercise treadmill test

Outcome Measures

Primary Outcome Measures

1. Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery) [20 minutes during exercise]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University	Nashville	Tennessee	United States	37027

Sponsors and Collaborators

• Vanderbilt University

Investigators

• Principal Investigator: Prince J Kannankeril, MD, MSCI, Vanderbilt University Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 28, 2016

More Information

Publications

None provided.

• Responsible Party: Prince Joseph Kannankeril, Associate Professor, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT02927223
• Other Study ID Numbers: VUMC-161398
• First Posted: Oct 6, 2016
• Last Update Posted: Jan 28, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular; Atropine

Study Results

Participant Flow

Arm/Group Title	Treadmill Then Treadmill With Atropine
Arm/Group Description	Patients will undergo treadmill exercise at baseline, then Patients will undergo treadmill exercise after IV atropine Atropine Exercise treadmill test
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treadmill Then Treadmill With Atropine
Arm/Group Description	Patients will undergo treadmill exercise at baseline, then Patients will undergo treadmill exercise after IV atropine Atropine Exercise treadmill test
Overall Participants	6
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	38
Sex: Female, Male (Count of Participants)
Female	1 16.7%
Male	5 83.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	6 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	6 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	6 100%

Outcome Measures

1. Primary Outcome

Title	Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery)
Time Frame	20 minutes during exercise

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treadmill	Treadmill With Atropine
Arm/Group Description	Patients will undergo treadmill exercise at baseline, Exercise treadmill test	Patients will undergo treadmill exercise after IV atropine Atropine Exercise treadmill test
Measure Participants	6	6
Median (Full Range) [number of ventricular beats]	46	0

Adverse Events

Time Frame	7 hours
Arm/Group Title	Treadmill		Treadmill With Atropine
Arm/Group Description	Patients will undergo treadmill exercise at baseline, Exercise treadmill test		Patients will undergo treadmill exercise after IV atropine Atropine Exercise treadmill test
All Cause Mortality
	Treadmill		Treadmill With Atropine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Serious Adverse Events
	Treadmill		Treadmill With Atropine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Treadmill		Treadmill With Atropine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.