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

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ClinicalTrials.gov Identifier: NCT04972123
Recruitment Status : Recruiting
First Posted : July 22, 2021
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 20, 2021
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine Fainting

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




Primary Outcome Measures :
  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 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 :
  1. Time to syncope or near-syncope after CPC or placebo administration [ Time Frame: During tilt table testing (up 35 minutes) ]
    Time in minutes

  2. Percentage of patients who have asystolic pauses > 3 sec in the CPC and placebo arms [ Time Frame: During tilt table testing (up 35 minutes) ]
    Asystole will be defined as absence of QRS complexes

  3. Fatigue Score at 1, 4, and 8 hours post tilt table testing [ Time Frame: Up to 8 hours after tilt table testing ]
    Self report of fatigue on a 1-5 scale where higher numbers indicate increased fatigue



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04972123


Contacts
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Contact: Mohamed H Hamdan, MD 608-263-1532 mhamdan@medicine.wisc.edu
Contact: Cassondra A Vander Ark, MS 608-265-0612 cav@medicine.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin- Madsion Recruiting
Madison, Wisconsin, United States, 53792
Contact: Mohamed H Hamdan, MD    608-263-1532    mhamdan@medicine.wisc.edu   
Contact: Cassondra A Vander Ark, MS    608-265-0612    cav@medicine.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Mohamed H Hamdan, MD University of Wisconsin, Madison
Publications:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04972123    
Other Study ID Numbers: 2021-0081
Protocol Version 3/13/2021 ( Other Identifier: UW Madison )
A534225 ( Other Identifier: UW Madison )
SMPH/MEDICINE/CARDIOLOGY ( Other Identifier: UW Madison )
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Neurocardiogenic Syncope
Reflex Syncope
Fainting Spells
Additional relevant MeSH terms:
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Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Phenylephrine
Oxymetazoline
Caffeine
Capsaicin
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants