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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Caffeine; Capsaicin; Oxymetazoline; Phenylephrine

Criteria

Inclusion Criteria:

1. Established diagnosis of typical vasovagal 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.