Trial Outcomes & Findings for The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope (NCT NCT04972123)
NCT ID: NCT04972123
Last Updated: 2024-07-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
During tilt table testing (up to approximately 35 minutes)
Results posted on
2024-07-17
Participant Flow
Participants were recruited at the University of Wisconsin- Madison using general recruitment emails addressed to students, faculty and staff and UW Heath Faint and Fall Clinic patients. All participants signed electronic consents in advance of study visit. The first participant completed the study in July 2021, and the last participant completed the study in August 2023.
Digital consent was obtained in 143 subjects. 14 subjects were not randomized for various reasons; no show (n=3), withdrew consent (n=4), SBP \> 130 mmHg (n=6) and not withholding Midodrine (n=1). A total of 129 subjects were randomized to CPC (n=66) or Placebo (n=63).
Participant milestones
| Measure |
CPC Adminstration
Single dose of CPC will be given during tilt table test at onset of prodromes. CPC - Capsaicin, Phenylephrine, Caffeine
|
Placebo Adminstration
Single dose of Placebo will be given during tilt table test at onset of prodromes
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
63
|
|
Overall Study
Primary Analysis Population
|
65
|
62
|
|
Overall Study
Secondary Analysis Population
|
32
|
27
|
|
Overall Study
COMPLETED
|
66
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope
Baseline characteristics by cohort
| Measure |
CPC Adminstration
n=65 Participants
Participant who were randomized to received CPC during Tilt Testing for which evaluable data was available.
|
Placebo Administration
n=62 Participants
Participant who were randomized to received Placebo during Tilt Testing for which evaluable data was available.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.2 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
26.2 Years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
26.2 Years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
62 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Syncope History
Participants with a history of syncope
|
60 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Syncope History
Participant with a history of near syncope
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During tilt table testing (up to approximately 35 minutes)Population: Intention to treat based on randomized treatment assignment
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.
Outcome measures
| Measure |
CPC Adminstration
n=65 Participants
Participant who were randomized to received CPC during Tilt Testing for which evaluable data was available.
|
Placebo Administration
n=62 Participants
Participant who were randomized to received Placebo during Tilt Testing for which evaluable data was available.
|
|---|---|---|
|
Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test
Number of participants with syncope or near syncope event
|
32 Participants
|
27 Participants
|
|
Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test
Number of participants without syncope or near syncope event
|
33 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: During tilt table testing (up to approximately 35 minutes)Population: Secondary endpoints analyses were limited to participants who had syncope or near syncope
Time in seconds from CPC or Placebo administration to syncope or near syncope in patients who had an event
Outcome measures
| Measure |
CPC Adminstration
n=32 Participants
Participant who were randomized to received CPC during Tilt Testing for which evaluable data was available.
|
Placebo Administration
n=27 Participants
Participant who were randomized to received Placebo during Tilt Testing for which evaluable data was available.
|
|---|---|---|
|
Time to Syncope or Near-syncope After CPC or Placebo Administration
|
90.1 seconds
Standard Deviation 95.0
|
76.9 seconds
Standard Deviation 95.0
|
SECONDARY outcome
Timeframe: During tilt table testing (up to approximately 35 minutes)Population: Secondary endpoints analyses were limited to participants who had syncope or near syncope
Percentage of Participants with an event who had asystolic pauses \> 3 seconds during syncope or near syncope
Outcome measures
| Measure |
CPC Adminstration
n=32 Participants
Participant who were randomized to received CPC during Tilt Testing for which evaluable data was available.
|
Placebo Administration
n=27 Participants
Participant who were randomized to received Placebo during Tilt Testing for which evaluable data was available.
|
|---|---|---|
|
Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 8 hours after tilt table testing (up to approximately 8 hours and 35 minutes)Population: Secondary endpoints analyses were limited to participants who had syncope or near syncope
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.
Outcome measures
| Measure |
CPC Adminstration
n=32 Participants
Participant who were randomized to received CPC during Tilt Testing for which evaluable data was available.
|
Placebo Administration
n=27 Participants
Participant who were randomized to received Placebo during Tilt Testing for which evaluable data was available.
|
|---|---|---|
|
Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing
Fatigue rated at 1 hour post tilt test
|
2.2 Score on a scale
Standard Deviation 1.05
|
2.0 Score on a scale
Standard Deviation 0.85
|
|
Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing
Fatigue rated at 4 hour post tilt test
|
2.2 Score on a scale
Standard Deviation 1.09
|
2.3 Score on a scale
Standard Deviation 1.07
|
|
Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing
Fatigue rated at 8 hour post tilt test
|
1.9 Score on a scale
Standard Deviation 0.91
|
2.6 Score on a scale
Standard Deviation 1.39
|
Adverse Events
CPC Adminstration
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Administration
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CPC Adminstration
n=66 participants at risk
Participants who were randomized to received CPC during Tilt Testing
|
Placebo Administration
n=63 participants at risk
Participants who were randomized to received Placebo during Tilt Testing
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.0%
2/66 • Number of events 2 • Start of study visit to 8 hours post CPC or Placebo administration
All symptoms reported by a participant that were unexpected in terms of intensity or duration were reported even if no study medication was given. The signs and symptoms associated with prodromes or events i.e. vasovagal syncope or near syncope were not reported as adverse events.
|
0.00%
0/63 • Start of study visit to 8 hours post CPC or Placebo administration
All symptoms reported by a participant that were unexpected in terms of intensity or duration were reported even if no study medication was given. The signs and symptoms associated with prodromes or events i.e. vasovagal syncope or near syncope were not reported as adverse events.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/66 • Number of events 1 • Start of study visit to 8 hours post CPC or Placebo administration
All symptoms reported by a participant that were unexpected in terms of intensity or duration were reported even if no study medication was given. The signs and symptoms associated with prodromes or events i.e. vasovagal syncope or near syncope were not reported as adverse events.
|
0.00%
0/63 • Start of study visit to 8 hours post CPC or Placebo administration
All symptoms reported by a participant that were unexpected in terms of intensity or duration were reported even if no study medication was given. The signs and symptoms associated with prodromes or events i.e. vasovagal syncope or near syncope were not reported as adverse events.
|
|
Nervous system disorders
Headache
|
1.5%
1/66 • Number of events 1 • Start of study visit to 8 hours post CPC or Placebo administration
All symptoms reported by a participant that were unexpected in terms of intensity or duration were reported even if no study medication was given. The signs and symptoms associated with prodromes or events i.e. vasovagal syncope or near syncope were not reported as adverse events.
|
4.8%
3/63 • Number of events 3 • Start of study visit to 8 hours post CPC or Placebo administration
All symptoms reported by a participant that were unexpected in terms of intensity or duration were reported even if no study medication was given. The signs and symptoms associated with prodromes or events i.e. vasovagal syncope or near syncope were not reported as adverse events.
|
|
Nervous system disorders
Migraine Headache
|
0.00%
0/66 • Start of study visit to 8 hours post CPC or Placebo administration
All symptoms reported by a participant that were unexpected in terms of intensity or duration were reported even if no study medication was given. The signs and symptoms associated with prodromes or events i.e. vasovagal syncope or near syncope were not reported as adverse events.
|
1.6%
1/63 • Number of events 1 • Start of study visit to 8 hours post CPC or Placebo administration
All symptoms reported by a participant that were unexpected in terms of intensity or duration were reported even if no study medication was given. The signs and symptoms associated with prodromes or events i.e. vasovagal syncope or near syncope were not reported as adverse events.
|
Additional Information
Mohamed H. Hamdan, MD, MBA
University of Wisconsin - Madison Cardiovascular Medicine
Phone: 608-263-4856
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place