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Histamine Modulation for Low Blood Pressure

Phase < 1
Recruiting
Led By John R Halliwill, PhD
Research Sponsored by University of Oregon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 -40
Be between 18 and 65 years old
Must not have
Ongoing medical therapy (other than birth control)
Prior diagnosis of cardiovascular disease, diabetes, autonomic disorders, or asthma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one hour
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a substance released from muscles during exercise can cause mast cells to release their contents.

Who is the study for?
This trial is for healthy adults aged 18-40 who have not been diagnosed with cardiovascular disease, diabetes, autonomic disorders, or asthma. Participants should not smoke or use nicotine and must not be on any antihistamines or ongoing medical therapy (except birth control). They cannot be pregnant, breastfeeding, planning pregnancy soon, highly active physically, overweight (BMI over 28), non-English speaking, or have high blood pressure.
What is being tested?
The study examines how histamine helps the body adapt to exercise by comparing the effects of aerobic exercise alone versus combined resistance and aerobic exercise. It also tests the impact of blocking histamine with a drug called alpha-FMH and using common antihistamines after exercising.
What are the potential side effects?
Potential side effects may include reactions to alpha-FMH such as headaches or nausea; typical antihistamine side effects like drowsiness or dry mouth; and general exercise-related discomforts including muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication other than birth control.
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I have been diagnosed with heart disease, diabetes, an autonomic disorder, or asthma.
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I regularly use antihistamines.
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I have difficulty moving around which affects my physical activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and one hour for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Histamine concentration
Histamine metabolites
Muscle perfusion
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Resistance and Aerobic ExerciseExperimental Treatment1 Intervention
Blood and urine collected during recovery from two modalities of exercise
Group II: HeatingExperimental Treatment1 Intervention
Blood and skeletal muscle microdialysate collected during local and/or whole body heating
Group III: Aerobic Exercise and Muscle PerfusionExperimental Treatment2 Interventions
Muscle perfusion measured during aerobic exercise
Group IV: Aerobic ExerciseExperimental Treatment1 Intervention
Blood and skeletal muscle microdialysate collected during dynamic knee-extension exercise
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise
2013
Completed Early Phase 1
~1350
Antihistamine
2016
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

University of OregonLead Sponsor
85 Previous Clinical Trials
44,158 Total Patients Enrolled
John R Halliwill, PhDPrincipal InvestigatorUniversity of Oregon

Media Library

Exercise (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05206227 — Phase < 1
Low blood pressure Research Study Groups: Aerobic Exercise, Heating, Resistance and Aerobic Exercise, Aerobic Exercise and Muscle Perfusion
Low blood pressure Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT05206227 — Phase < 1
Exercise (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05206227 — Phase < 1
~20 spots leftby Dec 2025
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