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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treadmill then Treadmill with Atropine | Experimental | Patients will undergo treadmill exercise at baseline, then Patients will undergo treadmill exercise after IV atropine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine | Drug |
| ||
| Exercise treadmill test |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery) | 20 minutes during exercise |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prince J Kannankeril, MD, MSCI | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32091590 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery) | Posted | Median | Full Range | number of ventricular beats | 20 minutes during exercise |
|
|
7 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treadmill | Patients will undergo treadmill exercise at baseline, Exercise treadmill test |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Prince Kannankeril | Vanderbilt University Medical Center | 615-322-7447 | prince.kannankeril@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2016 | Jan 16, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000098850 | Polymorphic Catecholaminergic Ventricular Tachycardia |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Procedure |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Treadmill With Atropine | Patients will undergo treadmill exercise after IV atropine Atropine Exercise treadmill test | 0 | 6 | 0 | 6 | 0 | 6 |
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| D002318 |
| Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |