The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Syncope, Vasovagal

Treatments: Diagnostic Test: Tilt Table Test; Drug: Placebo; Drug: CPC - Capsaicin, Phenylephrine, Caffeine

Study type: Interventional

Funder types: Other

Identifiers

NCT04972123

SMPH/MEDICINE/CARDIOLOGY (Other Identifier)

Protocol Version 4/12/2022 (Other Identifier)

2021-0081

A534225 (Other Identifier)

Details and patient eligibility

About

Syncope is defined as transient loss of consciousness associated with inability to maintain postural tone with rapid and spontaneous recovery. The purpose of this study is to assess the effects of sublingual administration of a new medication called CPC on tilt-induced syncope in patients with a history of vasovagal syncope (VVS) or near syncope. 140 participants will be randomized at the University of Wisconsin - Madison. Each participant will be in the study for 1 day.

Full description

Vasovagal syncope (VVS) is the most common type of syncope. The mechanism is reflex-mediated triggered by various afferent input to the brain. The event is usually preceded by diaphoresis, warmth, nausea, and pallor, and is followed by fatigue. While several drugs are indicated in the treatment of VVS, to our knowledge, there is no current treatment of an impending syncopal attack. In the present study, the investigators hypothesized that a single administration of sublingual CPC preparation during the prodromal phase would abort tilt-induced syncope or near syncope with SBP less than or equal to 70 mmHg in patients with a history of VVS. Patients with an established diagnosis of typical VVS or near syncope will be randomized to receive CPC or placebo in 1:1 ratio. Drug or placebo will be administered at the onset of prodromes during tilt table testing. In addition to the primary endpoint (syncope or near syncope with SBP less than or equal to 70 mmHg), the investigators will be assessing the effects of the drug on time to event, incidence of asystole (> 3 sec), and fatigue after syncope.

Enrollment: 143 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Established diagnosis of typical vasovagal syncope or near syncope
2. Age 18-50 years

Exclusion criteria

1. Systolic BP >130 mmHg
2. History of hypertension or cardiac arrhythmias
3. History of cardiovascular disease or cerebral ischemic events
4. Allergic reaction to any of the drug components
5. Contraindication to tilt testing
6. Any physical or psychological symptom, based on the clinical judgment of the investigators that would make a participant unsuitable for the study
7. Any use of a medication(s) based on the clinical judgment of the investigators that would make a participant unsuitable for the study (e.g. fludrocortisone, theophylline, prazosin, doxazosin, terazosin, MAO-inhibitors, pseudoephedrine, decongestant and PDE5 inhibitors).
8. Unwilling to discontinue Midodrine or beta-blocker therapy 48 hours before tilt table testing.
9. Women who are pregnant (confirmed with pregnancy test on day of study) or lactating.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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143 participants in 2 patient groups, including a placebo group

CPC Adminstration

Experimental group

Description:

Single dose of CPC will be given during tilt table test

Treatment:

Drug: CPC - Capsaicin, Phenylephrine, Caffeine

Diagnostic Test: Tilt Table Test

Placebo Adminstration

Placebo Comparator group

Description:

Single dose of Placebo will be given during tilt table test

Treatment:

Drug: Placebo

Diagnostic Test: Tilt Table Test