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

Syncope, Vasovagal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04972123
• Other study ID #: 2021-0081
• Secondary ID: Protocol Version
• Status: Completed
• Phase: Phase 2
• Start date: July 20, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 were randomized at the University of Wisconsin - Madison. Each participant will be in the study for 1 day.

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 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 tilt table testing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 31, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal

Intervention

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 nitroglycerin (NTG) administration and tilt testing for another 15 minutes (NTG Phase).

Drug:
• Placebo
Placebo for CPC

Locations

Country	Name	City	State
United States	University of Wisconsin- Madsion	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who have hypotensive syncope or near syncope with SBP less than or equal to 70 mmHG during tilt test	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.	During tilt table testing (up 35 minutes)
Secondary	Time to syncope or near-syncope after CPC or placebo administration	Time in minutes	During tilt table testing (up 35 minutes)
Secondary	Percentage of patients who have asystolic pauses > 3 sec in the CPC and placebo arms	Asystole will be defined as absence of QRS complexes	During tilt table testing (up 35 minutes)
Secondary	Fatigue Score at 1, 4, and 8 hours post tilt table testing	Self report of fatigue on a 1-5 scale where higher numbers indicate increased fatigue	Up to 8 hours after tilt table testing