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

NCT ID: NCT04972123

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-20
• Study Completion Date: 2023-08-31

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.

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 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.

Conditions

Syncope, Vasovagal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CPC Adminstration

Single dose of CPC will be given during tilt table test

Group Type: EXPERIMENTAL

CPC - Capsaicin, Phenylephrine, Caffeine

Intervention Type: DRUG

CPC is a combination of Capsaicin, Phenylephrine and Caffeine

Tilt Table Test

Intervention Type: 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 Adminstration

Single dose of Placebo will be given during tilt table test

Group Type: PLACEBO_COMPARATOR

Tilt Table Test

Intervention Type: 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

Intervention Type: DRUG

Placebo for CPC

Interventions

CPC - Capsaicin, Phenylephrine, Caffeine

CPC is a combination of Capsaicin, Phenylephrine and Caffeine

Intervention Type: DRUG

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 nitroglycerin (NTG) administration and tilt testing for another 15 minutes (NTG Phase).

Intervention Type: DIAGNOSTIC_TEST

Placebo

Placebo for CPC

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Established diagnosis of typical vasovagal syncope or near 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed H Hamdan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin- Madsion

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11194602 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Protocol Version 4/12/2022

Identifier Type: OTHER

Identifier Source: secondary_id

A534225

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/CARDIOLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

2021-0081

Identifier Type: -

Identifier Source: org_study_id