- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07285031
Histamines and Central Hemodynamics
December 16, 2025 updated by: Neil Eves, University of British Columbia
The Role of Histamines on Central Hemodynamics
When we exercise, more blood flow goes to our muscles, challenging our blood vessels.
Following exercise, blood flow remains elevated and seems to be the reason for many of the positive cardiovascular benefits that occur with exercise.
When the actions of histamine, a molecule primarily known for its role in allergies, are blocked, there is an attenuated blood flow response following exercise.
However, this effect has never been studied in the blood vessels that supply our lungs.
The purpose of this study is to examine the effects of histamines on pulmonary hemodynamics following exercise.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Neil Eves, PhD
- Phone Number: (250) 807-9676
- Email: neil.eves@ubc.ca
Study Contact Backup
- Name: Cassidy Williams, BHK
- Phone Number: (250) 807-9676
- Email: cwilli08@student.ubc.ca
Study Locations
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1V2L2
- Recruiting
- University of British Columbia
-
Contact:
- Neil Eves, PhD
- Phone Number: (250) 807-9676
- Email: neil.eves@ubc.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age: 19 - 39.
- Willing to visit the lab on 3 separate occasions.
Exclusion Criteria:
- Previously diagnosed heart condition,
- Previously diagnosed lung condition (including asthma),
- Previously diagnosed metabolic condition,
- Currently smokers (cigarettes, electronic cigarettes, cannabis) or who have smoked within the last 3 months,
- Resting blood pressure >140/90 mmHg,
- Unable to obtain appropriate quality ultrasound images of the heart.,
- Individuals without tricuspid regurgitation at rest to allow assessment of the primary outcome,
- Pregnant or trying to become pregnant,
- Breastfeeding,
- Chronically take antihistamines (i.e. daily),
- History of adverse reactions to antihistamines,
- Never taken antihistamines previously,
- Currently taking any medications (including oral contraceptives).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blockade + Exercise Bout
Participants will ingest histamine H1 receptor blockade before performing an exercise bout.
|
H1 receptor antagonist: 50mg Diphenhydramine Hydrochloride
Participants will complete a total of three 5-minute high intensity exercise intervals, interspersed with 5-minute lower intensity exercise bouts (4 total), for a total of 35 minutes.
|
|
Placebo Comparator: Placebo + Exercise Bout
Participants will ingest a placebo before an exercise bout.
|
Placebo
Participants will complete a total of three 5-minute high intensity exercise intervals, interspersed with 5-minute lower intensity exercise bouts (4 total), for a total of 35 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic pulmonary artery pressure
Time Frame: Pre-exercise and 10, 20, and 30-minutes post-exercise.
|
The difference in systolic pulmonary artery pressure (measured as tricuspid regurgitation velocity using echocardiography) between the H1 blockade condition and the placebo condition.
|
Pre-exercise and 10, 20, and 30-minutes post-exercise.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tricuspid annular plane systolic displacement
Time Frame: Pre-exercise and 0, 10, 20, 30, 45, and 60 minutes post-exercise.
|
The difference in tricuspid annular plane systolic displacement between the H1 receptor blockade condition and the placebo condition.
|
Pre-exercise and 0, 10, 20, 30, 45, and 60 minutes post-exercise.
|
|
Right ventricular stroke volume
Time Frame: Pre-exercise and 0, 10, 20, 30, 45, and 60-minutes post-exercise.
|
The difference in right ventricular stroke volume (measured using pulsed wave velocity of the right ventricular outflow tract velocity time integral) between the H1 receptor blockade condition and the placebo condition.
|
Pre-exercise and 0, 10, 20, 30, 45, and 60-minutes post-exercise.
|
|
Femoral artery blood flow
Time Frame: Pre-exercise and 0, 10, 20, 30, 45, and 60-minutes post-exercise.
|
The difference in femoral artery blood flow between the H1 receptor blockade condition and the placebo condition.
|
Pre-exercise and 0, 10, 20, 30, 45, and 60-minutes post-exercise.
|
|
Mean arterial systemic pressure
Time Frame: Pre-exercise and 0, 10, 20, 30, 45, and 60-minutes post-exercise.
|
The difference in mean arterial systemic pressure between the H1 receptor blockade condition and the placebo condition.
|
Pre-exercise and 0, 10, 20, 30, 45, and 60-minutes post-exercise.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
December 3, 2025
First Submitted That Met QC Criteria
December 3, 2025
First Posted (Estimated)
December 16, 2025
Study Record Updates
Last Update Posted (Actual)
December 23, 2025
Last Update Submitted That Met QC Criteria
December 16, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H25-01909
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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