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

Phase 2

Completed

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

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Systolic BP >130 mmHg
History of hypertension or cardiac arrhythmias
History of cardiovascular disease or cerebral ischemic events
Allergic reaction to any of the drug components
Contraindication to tilt testing
Any physical or psychological symptom, based on the clinical judgment of the investigators that would make a participant unsuitable for the study
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).
Unwilling to discontinue Midodrine or beta-blocker therapy 48 hours before tilt table testing.
Women who are pregnant (confirmed with pregnancy test on day of study) or lactating.

Arm && Interventions

Group	Intervention	Description
Placebo Adminstration	Tilt Table Test	Single dose of Placebo will be given during tilt table test
Placebo Adminstration	Placebo	Single dose of Placebo will be given during tilt table test
CPC Adminstration	Tilt Table Test	Single dose of CPC will be given during tilt table test
CPC Adminstration	CPC - Capsaicin, Phenylephrine, Caffeine	Single dose of CPC will be given during tilt table test

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test	During tilt table testing (up to approximately 35 minutes)	Hypotensive syncope is defined as transient loss of consciousness associated with SBP less than or equal to 90 mmHg. Near syncope is defined as sensation of "near fainting" while still being responsive to verbal commands. Near syncope will be used as a primary endpoint only when it is associated with a SBP less than or equal to 70 mmHg.
Time to Syncope or Near-syncope After CPC or Placebo Administration	During tilt table testing (up to approximately 35 minutes)	Time in seconds from CPC or Placebo administration to syncope or near syncope in patients who had an event

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms	During tilt table testing (up to approximately 35 minutes)	Percentage of Participants with an event who had asystolic pauses \> 3 seconds during syncope or near syncope
Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing	Up to 8 hours after tilt table testing (up to approximately 8 hours and 35 minutes)	Fatigue Scores at 1, 4 and 8 hours post tilt table testing in participants who had an event. Using standard continuous fatigue scale of 1 to 5, with 1 = no fatigue and 5 = max fatigue.