Catecholaminergic Polymorphic Ventricular Tachycardia
Conditions
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.
Interventions
DRUGAtropine
PROCEDUREExercise treadmill test
Sponsors
Vanderbilt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery) | 20 minutes during exercise |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treadmill Then Treadmill With Atropine Patients will undergo treadmill exercise at baseline, then Patients will undergo treadmill exercise after IV atropine
Atropine
Exercise treadmill test | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Treadmill Then Treadmill With Atropine |
|---|---|
| Age, Continuous | 38 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery)
Time frame: 20 minutes during exercise
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treadmill | Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery) | 46 number of ventricular beats |
| Treadmill With Atropine | Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery) | 0 number of ventricular beats |