Clinical trial NCT04972123: The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope
Official title: The Effect of Capsaicin-Phenylephrine-Caffeine Formulation on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Syncope, Vasovagal
Keywords: Neurocardiogenic Syncope
Reflex Syncope
Fainting Spells
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test
timeFrame: During tilt table testing (up to approximately 35 minutes)
measure: Time to Syncope or Near-syncope After CPC or Placebo Administration
timeFrame: During tilt table testing (up to approximately 35 minutes)
Secondary outcomes:
measure: Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms
timeFrame: During tilt table testing (up to approximately 35 minutes)
measure: Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing
timeFrame: Up to 8 hours after tilt table testing (up to approximately 8 hours and 35 minutes)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin- Madsion
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mohamed H Hamdan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bartoletti A, Alboni P, Ammirati F, Brignole M, Del Rosso A, Foglia Manzillo G, Menozzi C, Raviele A, Sutton R. 'The Italian Protocol': a simplified head-up tilt testing potentiated with oral nitroglycerin to assess patients with unexplained syncope. Europace. 2000 Oct;2(4):339-42. doi: 10.1053/eupc.2000.0125.