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

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Recruiting

CT.gov ID

NCT04972123

Collaborator

(none)

132

Enrollment

Location

Arms

29.4

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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). 132 participants will be enrolled at the University of Wisconsin - Madison. Each participant will be in the study for 1 day.

Condition or Disease	Intervention/Treatment	Phase
Syncope, Vasovagal	Drug: CPC - Capsaicin, Phenylephrine, Caffeine Diagnostic Test: Tilt Table Test Drug: Placebo	Phase 2

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 hypothesize that a single administration of sublingual CPC preparation during the prodromal phase aborts 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 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 tilt table testing.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Randomized 1:1 to CPC or placebo

Primary Purpose:

Treatment

Official Title:

The Effect of Capsaicin-Phenylephrine-Caffeine Formulation on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope

Actual Study Start Date :

Jul 20, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CPC Adminstration Single dose of CPC will be given during tilt table test	Drug: CPC - Capsaicin, Phenylephrine, Caffeine CPC is a combination of Capsaicin, Phenylephrine and Caffeine Diagnostic Test: Tilt Table Test Participant will undergo tilt tablet testing using the Italian protocol (see reference section). The Italian protocol includes 20 minutes of passive tilt at 70 degrees (Passive Phase) followed by nitrogylcerin (NTG) administration and tilt testing for another 15 minutes (NTG Phase).
Placebo Comparator: Placebo Adminstration Single dose of Placebo will be given during tilt table test	Diagnostic Test: Tilt Table Test Participant will undergo tilt tablet testing using the Italian protocol (see reference section). The Italian protocol includes 20 minutes of passive tilt at 70 degrees (Passive Phase) followed by nitrogylcerin (NTG) administration and tilt testing for another 15 minutes (NTG Phase). Drug: Placebo Placebo for CPC

Arm

Intervention/Treatment

Experimental: CPC Adminstration

Single dose of CPC will be given during tilt table test

Drug: CPC - Capsaicin, Phenylephrine, Caffeine

CPC is a combination of Capsaicin, Phenylephrine and Caffeine

Diagnostic Test: Tilt Table Test

Participant will undergo tilt tablet testing using the Italian protocol (see reference section). The Italian protocol includes 20 minutes of passive tilt at 70 degrees (Passive Phase) followed by nitrogylcerin (NTG) administration and tilt testing for another 15 minutes (NTG Phase).

Placebo Comparator: Placebo Adminstration

Single dose of Placebo will be given during tilt table test

Diagnostic Test: Tilt Table Test

Drug: Placebo

Placebo for CPC

Outcome Measures

Primary Outcome Measures

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 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.

Secondary Outcome Measures

Time to syncope or near-syncope after CPC or placebo administration [During tilt table testing (up 35 minutes)]
Time in minutes
Percentage of patients who have asystolic pauses > 3 sec in the CPC and placebo arms [During tilt table testing (up 35 minutes)]
Asystole will be defined as absence of QRS complexes
Fatigue Score at 1, 4, and 8 hours post tilt table testing [Up to 8 hours after tilt table testing]
Self report of fatigue on a 1-5 scale where higher numbers indicate increased fatigue

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Established diagnosis of typical vasovagal syncope
Age 18-50 years

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.