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Recruiting NCT07285031

Histamines and Central Hemodynamics

No phase Interventional Histamine Exercise

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diphenhydramine hydrochloride, Placebo, Exercise Bout.
Who it may be relevant to
Registry conditions: Histamine, Exercise. Basic parameters: 19 years — 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Role of Histamines on Central Hemodynamics

Overview

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.

Interventions

  • Drug Diphenhydramine hydrochloride
    H1 receptor antagonist: 50mg Diphenhydramine Hydrochloride
  • Other Placebo
    Placebo
  • Other 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.

Primary outcome measures

  • Systolic pulmonary artery pressure [Time frame: Pre-exercise and 10, 20, and 30-minutes post-exercise.]
Secondary outcome measures (4)
  • Tricuspid annular plane systolic displacement [Time frame: 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.]
  • Femoral artery blood flow [Time frame: 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.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Basic science

Study locations

Canada · 1 center
  • University of British Columbia — Kelowna

Identifiers

NCT: NCT07285031 · H25-01909

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗