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A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11) (POST 11)

Primary Purpose

Vasovagal Syncope (VVS), Syncope

Status
Not yet recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Ondansetron
Placebo
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasovagal Syncope (VVS) focused on measuring Ondansetron

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: (A) ≥1 syncopal spells in the year preceding enrolment (B) ≥-2 points on the Calgary Syncope Symptom Score( Accurate Calculation for Diagnosis of Vasovagal Syncope) (C) Age ≥18 years with informed consent Exclusion Criteria: other causes of syncope, such as ventricular tachycardia, complete heart block, orthostatic hypotension or hypersensitive carotid sinus syndrome an inability to give informed consent important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia hypertrophic cardiomyopathy a permanent pacemaker a seizure disorder hypertension defined as >160/90 mm Hg pregnancy lactating women glaucoma medications with known effects on BP Known hypersensitivity to ondansetron and related medications other factors which, in the investigator's opinion, would prevent the subject from completing the protocol.

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ondansetron

Placebo

Arm Description

2 doses of Ondansetron 8mg PO (evening before and morning of study)

2 doses of matching placebo 8 mg PO (evening before and morning of study)

Outcomes

Primary Outcome Measures

Time to syncope or presyncope

Secondary Outcome Measures

stroke volume
cardiac output
Heart Rate * Stroke volume, and it will be measured using Beat -To Beat BP measurement and HR measurement
catecholamine levels
Hospital Anxiety and Depression Scale (HADS)
The total score is out of 42, (21 per subscale). Scores are derived by summing responses for each of the two subscales or for the scale as a whole Higher scores indicate greater levels of anxiety or depression. The total HADS score may be regarded as a global measure of psychological distress
RAND-36
The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table
systemic vascular resistance
it will be measured using Beat -To Beat BP measurement

Full Information

First Posted
February 9, 2023
Last Updated
May 10, 2023
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT05755737
Brief Title
A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11)
Acronym
POST 11
Official Title
A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
About 20% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving, can be injured, and have poor quality of life. There are few therapies that have withstood the test of randomized clinical trials. the investigators will conduct a prospective, randomized, parallel, double-blind, proof-of-concept study that tests the hypothesis that serotonin 5HT3 receptor inhibition with ondansetron prevents tilt-induced vasovagal syncope (VVS) and pre-syncope in patients with clinical VVS. A total of 70 patients with quantitative clinical diagnostic criteria for VVS and at least 1 syncopal spell in the preceding year will be randomized in a double-blind acute phase 2 study to ondansetron 8 mg PO BID x 2 doses or matching placebo. The endpoint will be presyncope or syncope associated with diagnostic hemodynamic changes. These data should provide useful preliminary data as a foundation on which to conduct a subsequent randomized clinical trial.
Detailed Description
This will be a randomized, double-blind, parallel-arm study in which the subjects will undergo a tilt table test following 2 doses of ondansetron 8 mg PO (evening before and morning of study) or after 2 doses of matching placebo (on separate days). On the morning of the study, the fasting subject (except for medications) will be instrumented, on an empty bladder. ECG electrodes will be applied to monitor continuous heart rhythm. BP will be monitored continuously using a finger volume clamp method using one or more of several extant devices, and calibrated with intermittent brachial cuff measurements. One intravenous cannula will be placed in the contralateral arm (to the BP cuff) for blood sampling. 3.9. Tilt Table Protocol: Following the insertion of the venous cannulae, a period of at least 20 minutes will be allowed to elapse before a 10-minute basal control (baseline) period. Baseline data will be digitally recorded in this time. In the last 5 minutes of this period, blood will be drawn for fractionated plasma catecholamines. The table will be rapidly raised to 80 degrees for up to 60 minutes. The Investigators are avoiding tilt test methods with provocative medications to avoid the issue of multiple causal factors. At 10 minutes and 30 minutes following onset of tilt (or at the onset of severe presyncope or hypotension [systolic BP <70 mmHg]), venous fractionated catecholamines will be sampled. The study will be terminated if the subject develops syncope or at the completion of the protocol. 3.10. Assessment of Central Volume Changes with Upright Posture: Segmental bioelectrical impedance (BEI) will measure fluid shifts through the study to determine central volume changes with upright posture and in response to changing levels of CO2. The fluid content in the upper torso (chest), the lower torso (abdominal), thigh, and calf will be assessed. BEI is measured by passing a small current between electrodes and measuring the impedance with voltage-sensing electrodes to determine fluid content in four regions of the body . Body segment volume is inversely proportional to electrical resistance (V~1/R), so an increase in resistance reflects a loss of body fluid. 3.11. Questionnaires: A brief online questionnaire will be administered to the patients to get a metric of their health-related quality of life (RAND-36), and anxiety and depression symptoms (HADS). This will be administered through RedCap Survey.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasovagal Syncope (VVS), Syncope
Keywords
Ondansetron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ondansetron
Arm Type
Active Comparator
Arm Description
2 doses of Ondansetron 8mg PO (evening before and morning of study)
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
2 doses of matching placebo 8 mg PO (evening before and morning of study)
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
Serotonin antagonists (5-HT3 antagonists) (Carbazole Derivative)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo identical in appearance.
Primary Outcome Measure Information:
Title
Time to syncope or presyncope
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
stroke volume
Time Frame
1 hour
Title
cardiac output
Description
Heart Rate * Stroke volume, and it will be measured using Beat -To Beat BP measurement and HR measurement
Time Frame
1 hour
Title
catecholamine levels
Time Frame
1 hour
Title
Hospital Anxiety and Depression Scale (HADS)
Description
The total score is out of 42, (21 per subscale). Scores are derived by summing responses for each of the two subscales or for the scale as a whole Higher scores indicate greater levels of anxiety or depression. The total HADS score may be regarded as a global measure of psychological distress
Time Frame
Within 12 months period of the study
Title
RAND-36
Description
The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table
Time Frame
Within 12 months period of the study
Title
systemic vascular resistance
Description
it will be measured using Beat -To Beat BP measurement
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (A) ≥1 syncopal spells in the year preceding enrolment (B) ≥-2 points on the Calgary Syncope Symptom Score( Accurate Calculation for Diagnosis of Vasovagal Syncope) (C) Age ≥18 years with informed consent Exclusion Criteria: other causes of syncope, such as ventricular tachycardia, complete heart block, orthostatic hypotension or hypersensitive carotid sinus syndrome an inability to give informed consent important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia hypertrophic cardiomyopathy a permanent pacemaker a seizure disorder hypertension defined as >160/90 mm Hg pregnancy lactating women glaucoma medications with known effects on BP Known hypersensitivity to ondansetron and related medications other factors which, in the investigator's opinion, would prevent the subject from completing the protocol.
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11)

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