Vein Expansion Techniques for High Blood Pressure
(OH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether expanding veins in the legs affects blood pressure when standing, a condition known as orthostatic hypertension. Participants will be divided into groups to test methods such as applying pressure or tilting the body, with or without additional pressure. Ideal candidates include those with stage I hypertension (mildly high blood pressure) who experience increased blood pressure when standing, or those without major health issues. As an unphased trial, this study provides a unique opportunity to contribute to understanding innovative methods for managing blood pressure.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have stage I hypertension, you may be included in the study, suggesting that some medications might be allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that tilt tests, such as the tilt with external pressure treatment, are generally safe. These tests have been used for many years to understand why people faint or feel dizzy. Although mostly safe, some individuals might feel uncomfortable due to reduced blood flow to the heart during the test.
For the limb occlusion with negative pressure method, studies indicate that negative pressure is often used safely in wound healing treatments. It works by applying gentle suction to aid healing. While usually safe, monitoring its use is important to prevent any issues.
Overall, these treatments have been used in other medical settings and are generally well-tolerated. However, like any treatment, risks exist, so staying informed and asking questions is crucial.12345Why are researchers excited about this trial?
Researchers are excited about the Vein Expansion Techniques for High Blood Pressure trial because it explores innovative, non-pharmacological methods to manage hypertension. Unlike standard medications that often focus on reducing blood volume or dilating blood vessels, this trial investigates physical interventions like limb occlusion and body tilting combined with pressures to influence blood flow and pressure. These techniques could offer a new way to manage blood pressure without the side effects of drugs, potentially benefiting those who prefer or require non-drug therapies. Additionally, by using methods like negative pressure or external pressure, researchers aim to understand how mechanical changes in the body can directly impact blood pressure regulation. This trial could pave the way for alternative treatments that are both effective and less dependent on medication.
What evidence suggests that this trial's treatments could be effective for high blood pressure?
This trial will compare different vein expansion techniques for high blood pressure. Research has shown that the head-up tilt test (HUTT), which participants in this trial may undergo, is useful for studying how blood pressure changes when someone stands up. During this test, blood pressure can drop significantly, aiding in understanding blood pressure control. The tilt test has been safely used for many years to observe how the heart and blood vessels react to different positions.
Another technique under study in this trial is limb occlusion with negative pressure. Research indicates that using negative pressure on the limbs can greatly increase blood flow. Specifically, one study found that skin blood flow increased by 89% shortly after applying negative pressure. This suggests that combining limb occlusion with negative pressure might effectively influence blood pressure responses.678910Who Is on the Research Team?
Jian Cui
Principal Investigator
Penn State College of Medicine
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo experimental models involving limb occlusion and negative pressure to study the venous distension reflex and its impact on blood pressure and sympathetic nerve activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Limb occlusion + negative pressure
- Limb occlusion + no negative pressure
- Tilt + external pressure
- Tilt + no external pressure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor