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Vein Expansion Techniques for High Blood Pressure (OH Trial)

N/A
Recruiting
Led By Jian Cui
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are 18 years of age
Are capable of giving informed consent
Must not have
History of blood clots
Age < 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recorded continuously during visit 2, the 4-5 hr negative pressure study visit.

Summary

This trial is testing whether expanding veins in the legs will lead to an increase in blood pressure.

Who is the study for?
This trial is for adults over 18 who can consent and speak English. It's for those with a specific type of high blood pressure that increases when standing, or normal blood pressure individuals matched by gender, age, and body size to the first group. Pregnant women, smokers, people with chronic diseases other than stage I hypertension, or history of blood clots are excluded.
What is being tested?
The study tests if leg vein distension affects blood pressure during changes in posture. Participants will experience limb occlusion (blocking blood flow) with or without negative pressure and tilting with or without external pressure to simulate these conditions.
What are the potential side effects?
Possible side effects may include discomfort from limb occlusion and changes in posture like dizziness due to shifts in blood pressure. However, detailed side effects aren't provided as this study focuses on physiological responses rather than drug interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I understand the study and can agree to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had blood clots in the past.
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I am under 18 years old.
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I have a chronic disease, but not stage I hypertension.
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I have low blood pressure when standing or a history of fainting.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recorded continuously during visit 2, the 4-5 hr negative pressure study visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and recorded continuously during visit 2, the 4-5 hr negative pressure study visit. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Muscle Tissue
Secondary study objectives
Blood pressure in mmHg
Heart rate in beats per minute

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Tilt + external pressureExperimental Treatment1 Intervention
Tilt + external pressure on legs performed in both "BP elevated with standing" and "BP maintained with standing" groups.
Group II: Limb occlusion + negative pressureExperimental Treatment1 Intervention
Limb occlusion + negative pressure performed in both "BP elevated with standing" and "BP maintained with standing" groups.
Group III: Tilt + no external pressurePlacebo Group1 Intervention
Tilt + no external pressure performed in both "BP elevated with standing" and "BP maintained with standing" groups.
Group IV: Limb occlusion + no negative pressurePlacebo Group1 Intervention
Limb occlusion + no negative pressure performed in both "BP elevated with standing" and "BP maintained with standing" groups.

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
510 Previous Clinical Trials
2,796,444 Total Patients Enrolled
Jian CuiPrincipal InvestigatorPenn State College of Medicine
1 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

Limb occlusion + negative pressure Clinical Trial Eligibility Overview. Trial Name: NCT03496792 — N/A
High Blood Pressure Research Study Groups: Tilt + external pressure, Tilt + no external pressure, Limb occlusion + negative pressure, Limb occlusion + no negative pressure
High Blood Pressure Clinical Trial 2023: Limb occlusion + negative pressure Highlights & Side Effects. Trial Name: NCT03496792 — N/A
Limb occlusion + negative pressure 2023 Treatment Timeline for Medical Study. Trial Name: NCT03496792 — N/A
~3 spots leftby Jun 2025
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