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HypertensionPhase 1NCT01426529

Caveolin-1 and Vascular Dysfunction

A Phase 1 study testing Para-aminohippuric Acid, Angiotensin II and Norepinephrine in people with Hypertension and Insulin Resistance, run by Brigham and Women's Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Caveolin-1 and Vascular Dysfunction Thank you for your interest in the investigators Blood Pressure Research Study. The National Institutes of Health are sponsoring us to investigate why patients develop high blood pressure, atherosclerosis (hardening of the arteries), and heart disease. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hypertension, Insulin Resistance
What is being tested?
Para-aminohippuric Acid, Angiotensin II and Norepinephrine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
1 Oct 2010to 15 Oct 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age 18-65
  • mild to moderate hypertension
  • no other major illnesses
  • BMI < or equal to 40

Who cannot join

  • secondary illnesses
  • BMI > 40
  • taking 4 or more anti-hypertensive medications
  • BP >160/100 on screening exam
  • Alcohol intake >12 oz per week
  • Current smoking
  • Recreational drug use
  • use of birth control pills or contraceptive hormone shots

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Caveolin-1 and Vascular Dysfunction

Thank you for your interest in the investigators Blood Pressure Research Study. The National Institutes of Health are sponsoring us to investigate why patients develop high blood pressure, atherosclerosis (hardening of the arteries), and heart disease. There are two parts of the investigators research program. The first part is a screening visit. At this visit you will be given a brief physical exam and will be asked questions concerning your medical history. During the same visit you will have your blood drawn for routine screening and genetic testing. You will also be asked to collect a urine sample for routine screening.

Read more

If the doctor finds that you are a healthy candidate you will be invited to participate in the second part of the study. During Phase II, the investigators will perform physiological tests after you are placed on a low salt diet and again after you are placed on a higher salt diet. If you are on blood pressure medication, it may be necessary to discontinue taking your present medication for up to three months before beginning the study. Patients discontinuing their current blood pressure medication may be placed on a different blood pressure medication during this 'washout' period if necessary to maintain blood pressure at pre-study levels.

Once your blood pressure medications are discontinued, you will be closely monitored. If you do not own a home blood pressure monitor, the investigators will provide one for you to use during the study so that you can keep a daily record of your blood pressure readings. The investigators will ask you to call us every three days to report your blood pressure readings. After you have stopped taking your medication, dieticians at the hospital will make you low salt meals to eat at home for about seven days. On the last day of the low salt diet, you will be asked to begin a 24-hour urine collection that you will bring with you when you are admitted to the hospital that evening. That morning, you will be required to come to the Center for Clinical Investigations (CCI) at Brigham and Women's Hospital for a one-hour test to check if your body is in the correct salt balance.

You will return that evening to the CCI where you will be admitted for your study that will occur the next morning. On the morning of your low salt study, the investigators will collect some blood samples. The investigators will also take ultrasound pictures of your heart to see how salt and hormones affect the way your heart and blood vessels functions. These tests will last approximately 5 hours and you will be discharged around 2:00 PM. For the next 5-7 days, you will be placed on a high salt diet. During this diet period, you will eat all your own food, but the investigators will give you some supplements to add to your meals. After 5-7 days on your high salt diet, on the morning of your second admission to the hospital, you will be asked to begin a final 24-hour urine collection. That morning, you will again be required to come to the CCI for a blood test, and you will return later that evening to the inpatient CCI where you will be admitted for your final overnight study. The same study that was done for the low salt diet will be repeated for the high salt study. You will be discharged at around 2:00 p.m. These studies will help to determine if you are salt-sensitive. In addition, the investigators hope to learn more about the hormones that regulate your blood pressure and the genes responsible for regulating those hormones.

You will have the option to spend a second night in the CCI after each diet phase in order to participate in an optional study of the blood vessels in the arm. This study also uses an ultrasound machine. It will last about 2 hours in the morning.

You will be placed back on your initial blood pressure medication (if you are on any) and returned to your regular physician for care. The investigators can also provide clinically relevant information to you.

Being tested
Para-aminohippuric Acid, Angiotensin II, Norepinephrine
Medical subject headings
Hypertension, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Para-aminohippuric AcidDrug

    Also called PAH

    Aminohippurate sodium is an agent to measure effective renal plasma flow (ERPF). It is the sodium salt of para-aminohippuric acid, commonly abbreviated "PAH".

  • Angiotensin IIDrug

    Also called AngII, AII

    Angiotensin II (Ang II) is a naturally occurring hormone whose primary purpose is to regulate the body's internal volume. It accomplishes this task by influencing the function of a variety of organs and tissues. It increases aldosterone secretion from the adrenal gland. It causes blood vessels to contract, particularly renal blood vessels, and it modifies the way the heart works.

  • NorepinephrineDrug

    Also called NE

    A hormone that is normally present in your body, which regulates your blood pressure.

Study groups in NCT01426529
Study groupRoleWhat they receive
major allele homozygousExperimentalwe will compare this arm with the minor allele carrier arm
Receives: Drug: Para-aminohippuric Acid; Drug: Angiotensin II; Drug: Norepinephrine
minor allele carriersExperimentalwe will compare this arm with the major allele homozygous arm
Receives: Drug: Para-aminohippuric Acid; Drug: Angiotensin II; Drug: Norepinephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Genetic Variation at the Caveolin-1 Locus

    We are testing our hypothesis that genetic variation at the cav-1 locus is a determinant of vascular phenotypes in hypertensive subjects. We will recruit hypertensive subjects who will be classified into two groups according to genotype status at rs926198 of CAV-1. Vascular function status will be determined using four markers: renal blood flow (primary endpoint), brachial artery reactivity, aortic compliance, and blood pressure levels.

    We will assess these endpoints before and after two provocations: low vs. high salt intake and AngII infusion.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2011 (estimated)
  2. Study start1 Oct 2010
  3. Primary completion15 Oct 2026 (estimated)
  4. Study completion15 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01426529
Sponsor's protocol ID
2010P002187
Other IDs
1R01HL104032-01
Status last verified
Dec 2025
First submitted
30 Aug 2011
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Brown JM, Williams JS, Luther JM, Garg R, Garza AE, Pojoga LH, Ruan DT, Williams GH, Adler GK, Vaidya A. Human interventions to characterize novel relationships between the renin-angiotensin-aldosterone system and parathyroid hormone. Hypertension. 2014 Feb;63(2):273-80. doi: 10.1161/HYPERTENSIONAHA.113.01910. Epub 2013 Nov 4.

    PubMed 24191286

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Para-aminohippuric Acid, Angiotensin II and Norepinephrine in people with Hypertension and Insulin Resistance, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Genetic Variation at the Caveolin-1 Locus (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01426529, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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Caveolin-1 and Vascular Dysfunction (NCT01426529) | AzTrials