Caveolin-1 for High Blood Pressure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how different salt levels in a diet affect blood pressure and heart health. Researchers are investigating the roles of genes and hormones in high blood pressure and heart disease. Participants will follow both low-salt and high-salt diets while undergoing various tests to observe their body's reactions. Suitable candidates include those with mild to moderate high blood pressure who do not have other major health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
If you are on blood pressure medication, you may need to stop taking it for up to three months before the study starts. During this time, you might be given a different medication to keep your blood pressure stable.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that reducing salt intake can lower blood pressure, benefiting heart health and potentially reducing the risk of heart disease. However, consuming too little salt might have drawbacks. Some studies suggest a slightly higher risk of heart issues with very low salt intake, though the evidence remains weak.
Conversely, excessive salt consumption links to higher blood pressure and an increased risk of heart problems. Too much salt can lead to serious health issues like stroke and heart failure. Balancing salt intake is crucial for overall health.
In this trial, participants will follow both high and low salt diets to observe how their bodies respond to varying salt levels. Both diet plans are generally safe, but adhering closely to study guidelines is important to ensure smooth progress. The trial is in its early stages, focusing on safety and determining optimal conditions for future studies.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it explores the impact of dietary salt intake on vascular health, focusing on genetic differences among participants. Unlike standard treatments for vascular dysfunction, which often involve medications like ACE inhibitors or beta-blockers, this trial investigates how a high or low salt diet might affect individuals differently based on their genetic makeup. By comparing minor allele carriers with major allele homozygous individuals, researchers aim to uncover personalized dietary recommendations that could prevent or manage vascular dysfunction more effectively. This approach could lead to more tailored and potentially less invasive treatment options that are specifically beneficial for individuals based on their genetic profile.
What evidence suggests that this trial's treatments could be effective for high blood pressure?
This trial examines how varying salt intake affects blood pressure and heart health, with participants assigned to either a High Salt Diet or a Low Salt Diet. Reducing dietary salt can lower blood pressure, crucial for preventing heart disease and related health issues. Research has shown that consuming less salt significantly reduces both systolic and diastolic blood pressure. Conversely, high salt intake is linked to increased blood pressure and a higher risk of heart problems. Although some studies suggest that very low salt intake might slightly raise the risk of certain conditions in specific groups, the overall evidence supports the benefits of reduced salt consumption for individuals with high blood pressure. This trial also investigates how the protein Caveolin-1 affects blood vessels.26789
Who Is on the Research Team?
Luminita Pojoga, PhD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with mild to moderate high blood pressure, who are generally healthy and have a BMI of 40 or less. Participants should not be suffering from other major illnesses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Washout
Participants discontinue current blood pressure medication for up to three months, with monitoring and possible substitution with another medication
Low Salt Diet
Participants are placed on a low salt diet for physiological testing, including blood and urine tests, and ultrasound imaging
High Salt Diet
Participants are placed on a high salt diet for physiological testing, including blood and urine tests, and ultrasound imaging
Optional Vascular Study
Participants may opt into an additional study of blood vessels in the arm using ultrasound
Follow-up
Participants are monitored for safety and effectiveness after the dietary interventions and returned to their regular physician for care
What Are the Treatments Tested in This Trial?
Interventions
- High Salt Diet
- Low Salt Diet
Trial Overview
The study investigates the effects of salt intake on blood pressure and heart function using diets with different salt levels. It involves stopping current blood pressure meds, monitoring at home, hospital tests including ultrasound, and analyzing hormones that regulate blood pressure.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
we will compare this arm with the major allele homozygous arm
we will compare this arm with the minor allele carrier arm
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Citations
Dietary salt intake and cardiovascular outcomes
According to the quality assessment, three outcomes (25%) were graded as Class III, four (33%) as Class IV, and five (42%) as NS.
Sodium reduction
The primary health effect associated with diets high in sodium is raised blood pressure which increases the risk of cardiovascular diseases, ...
Experts criticize new study about salt consumption
A new study suggests reducing excessive salt benefits some people with high blood pressure, but low-sodium diets don't help people with lower risks for heart ...
The World Hypertension League Science of Salt
Overall, these studies showed that increased or higher sodium intake is associated with poorer health outcomes. In the series of Science of Salt ...
5.
escardio.org
escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-22/salt-and-hypertension-current-viewsSalt and hypertension: current views
The association between sodium consumption and hypertension is well known, as high sodium intake can negatively affect control of hypertension.
Addressing the dangers of high sodium intake for a better ...
High sodium intake is linked to increased blood pressure, higher triglycerides, and 1.89 million deaths yearly, raising cardiovascular disease ...
7.
heart.org
heart.org/en/healthy-living/healthy-eating/eat-smart/sodium/effects-of-excess-sodium-infographicEffects of Excess Sodium Infographic
Excess levels of sodium/salt may put you at risk for: Enlarged heart muscle; Headaches; Kidney disease; Osteoporosis; Stroke; Heart failure; High blood pressure ...
Salt Sensitivity: Causes, Consequences, and Recent ...
Excess salt intake leads to elevation in blood pressure which drives cardiovascular morbidity and mortality.
About Sodium and Health | Salt
Too much sodium, mostly from salt, increases blood pressure and risk of heart disease and stroke. Most Americans consume over 3,300mg daily, ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.