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Completed

NCT Number: NCT04972123

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

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.

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Key information

Conditions

Syncope, Vasovagal Autonomic Nervous System Diseases Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthostatic Intolerance Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Syncope Unconsciousness

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin- Madsion

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Women who are pregnant (confirmed with pregnancy test on day of study) or lactating.

Treatment and study plan

CPC - Capsaicin, Phenylephrine, Caffeine

Drug

CPC is a combination of Capsaicin, Phenylephrine and Caffeine

Tilt Table Test

Diagnostic 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).

Placebo

Drug

Placebo for CPC

Primary outcomes

  1. Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms

    Time frame: 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

  2. Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2021
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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