NCT07285031

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Dec 2025Aug 2026

Study Start

First participant enrolled

December 1, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

December 3, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

histamineexercisepulmonary blood flowpulmonary functionfemoral blood flow

Outcome Measures

Primary Outcomes (1)

  • Systolic pulmonary artery pressure

    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 Outcomes (4)

  • Tricuspid annular plane systolic displacement

    Pre-exercise and 0, 10, 20, 30, 45, and 60 minutes post-exercise.

  • Right ventricular stroke volume

    Pre-exercise and 0, 10, 20, 30, 45, and 60-minutes post-exercise.

  • Femoral artery blood flow

    Pre-exercise and 0, 10, 20, 30, 45, and 60-minutes post-exercise.

  • Mean arterial systemic pressure

    Pre-exercise and 0, 10, 20, 30, 45, and 60-minutes post-exercise.

Study Arms (2)

Blockade + Exercise Bout

EXPERIMENTAL

Participants will ingest histamine H1 receptor blockade before performing an exercise bout.

Drug: Diphenhydramine hydrochlorideOther: Exercise Bout

Placebo + Exercise Bout

PLACEBO COMPARATOR

Participants will ingest a placebo before an exercise bout.

Other: PlaceboOther: Exercise Bout

Interventions

H1 receptor antagonist: 50mg Diphenhydramine Hydrochloride

Blockade + Exercise Bout
PlaceboOTHER

Placebo

Placebo + Exercise Bout

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.

Blockade + Exercise BoutPlacebo + Exercise Bout

Eligibility Criteria

Age19 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 19 - 39.
  • Willing to visit the lab on 3 separate occasions.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V2L2, Canada

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Diphenhydramine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

EthylaminesAminesOrganic ChemicalsBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Central Study Contacts

Neil Eves, PhD

CONTACT

Cassidy Williams, BHK

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 3, 2025

First Posted

December 16, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations