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

NCT04972123 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: 2021-0081Protocol Version 4/12/2022A534225SMPH/MEDICINE/CARDIOLOGY
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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) or near syncope. 140 participants will be randomized at the University of Wisconsin - Madison. Each participant will be in the study for 1 day.

Conditions

Syncope, Vasovagal

Keywords

Neurocardiogenic Syncope; Reflex Syncope; Fainting Spells

Outcome Measures

Primary Outcomes (2)

• 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 to approximately 35 minutes)

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

  Time in seconds from CPC or Placebo administration to syncope or near syncope in patients who had an event

  During tilt table testing (up to approximately 35 minutes)

Secondary Outcomes (2)

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

  During tilt table testing (up to approximately 35 minutes)

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

  Up to 8 hours after tilt table testing (up to approximately 8 hours and 35 minutes)

Study Arms (2)

CPC Adminstration

EXPERIMENTAL

Single dose of CPC will be given during tilt table test

Drug: CPC - Capsaicin, Phenylephrine, Caffeine; Diagnostic Test: Tilt Table Test

Placebo Adminstration

PLACEBO COMPARATOR

Single dose of Placebo will be given during tilt table test

Diagnostic Test: Tilt Table Test; Drug: Placebo

Interventions

CPC - Capsaicin, Phenylephrine, Caffeine DRUG

CPC is a combination of Capsaicin, Phenylephrine and Caffeine

CPC Adminstration

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).

CPC Adminstration; Placebo Adminstration

Placebo DRUG

Placebo for CPC

Placebo Adminstration

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Established diagnosis of typical vasovagal syncope or near syncope
• Age 18-50 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin- Madsion

Madison, Wisconsin, 53792, United States

Location

Related 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.

  PMID: 11194602 BACKGROUND

MeSH Terms

Conditions

Syncope, Vasovagal; Syncope

Interventions

Phenylephrine; Caffeine; Tilt-Table Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Mohamed H. Hamdan, MD, MBA
• Organization: University of Wisconsin - Madison Cardiovascular Medicine

mhamdan@medicine.wisc.edu

608-263-4856

Study Officials

• Mohamed H Hamdan, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomized 1:1 to CPC or placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: July 20, 2021
• Primary Completion: August 25, 2023
• Study Completion: August 31, 2023
• Last Updated: July 17, 2024
• Results First Posted: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)