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Atropine in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

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ClinicalTrials.gov Identifier: NCT02927223
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Prince Joseph Kannankeril, 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.

Condition or disease Intervention/treatment Phase
Catecholaminergic Polymorphic Ventricular Tachycardia Drug: Atropine Procedure: Exercise treadmill test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Crossover 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 : October 2016
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 2019


Arm Intervention/treatment
Placebo Comparator: Baseline
Patients will undergo treadmill exercise at baseline
Procedure: Exercise treadmill test
Active Comparator: atropine
Patients will undergo treadmill exercise after IV atropine
Drug: Atropine
Procedure: Exercise treadmill test



Primary Outcome Measures :
  1. number of ventricular ectopic beats recorded during exercise (and recovery) [ Time Frame: 20 minutes during exercise and recovery ]


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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927223


Locations
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United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37027
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Prince J Kannankeril, MD, MSCI Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Prince Joseph Kannankeril, Vanderbilt University:
Informed Consent Form  [PDF] May 23, 2018


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Responsible Party: Prince Joseph Kannankeril, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02927223     History of Changes
Other Study ID Numbers: VUMC-161398
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action