CompletedPhase 2

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

United States143 participantsStarted 2021-07-20

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Established diagnosis of typical vasovagal syncope or near 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.

What they're measuring

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)

Time to Syncope or Near-syncope After CPC or Placebo Administration

Timeframe: During tilt table testing (up to approximately 35 minutes)

Trial details

NCT IDNCT04972123

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-25

Results submitted2024-05-28

View on ClinicalTrials.gov More Syncope, Vasovagal trials

Plain-language summary

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Established diagnosis of typical vasovagal syncope or near 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.

What they're measuring

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)

Time to Syncope or Near-syncope After CPC or Placebo Administration

Timeframe: During tilt table testing (up to approximately 35 minutes)