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.
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
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.
- Conditions
- Hypertension, Insulin Resistance
- 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 group | Role | What they receive |
|---|---|---|
| major allele homozygous | Experimental | we will compare this arm with the minor allele carrier arm Receives: Drug: Para-aminohippuric Acid; Drug: Angiotensin II; Drug: Norepinephrine |
| minor allele carriers | Experimental | we 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.
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.
- First posted31 Aug 2011 (estimated)
- Study start1 Oct 2010
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Luminita Pojoga, Brigham and Women's Hospital
- Investigators
- Luminita Pojoga, PhD, Principal investigator, Brigham and Women's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caveolin-1 and Vascular Dysfunction
- ClinicalTrials.gov ID
- NCT01426529
- Acronym / sponsor ID
- 2010P002187
- Conditions
- Hypertension, Insulin Resistance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Study start
- 1 Oct 2010 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 31 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| major allele homozygous | Experimental | Drug: Para-aminohippuric Acid, Drug: Angiotensin II, Drug: Norepinephrinewe will compare this arm with the minor allele carrier arm |
| minor allele carriers | Experimental | Drug: Para-aminohippuric Acid, Drug: Angiotensin II, Drug: Norepinephrinewe will compare this arm with the major allele homozygous arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-65
- mild to moderate hypertension
- no other major illnesses
- BMI < or equal to 40
Key exclusion criteria (8 listed)
- secondary illnesses
- BMI > 40
- taking 4 or more anti-hypertensive medications
- BP >160/100 on screening exam
- Alcohol intake >12 oz per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Para-aminohippuric AcidAlso: PAHAminohippurate sodium is an agent to measure effective renal plasma flow (ERPF). It is the sodium salt of para-aminohippuric acid, commonly abbreviated "PAH". | Drug | major allele homozygous, minor allele carriers |
| Angiotensin IIAlso: AngII, AIIAngiotensin 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. | Drug | major allele homozygous, minor allele carriers |
| NorepinephrineAlso: NEA hormone that is normally present in your body, which regulates your blood pressure. | Drug | major allele homozygous, minor allele carriers |
Primary outcome
Genetic Variation at the Caveolin-1 Locus
Time frame: 5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Derived from this study: PubMed 24191286Brown 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luminita Pojoga, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
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.