Adrenal Gland NeoplasmNCT03374215
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
An observational study of Adrenal Gland Neoplasm and Hypertension, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: The adrenal gland makes the hormone aldosterone. This helps regulate blood pressure. An adrenal gland tumor that makes too much aldosterone can cause high blood pressure and low potassium. The cause of these tumors is unknown, but sometimes they are inherited. Read more about this study
- Who is it for?
- Ages 7 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Adrenal Gland Neoplasm, Hypertension, Bone Diseases, Metabolic
- How many people
- 1,150 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2017to 31 Dec 2026
- Phase
- Observational
- 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 7 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Primary clinical, referrals from community physicians@@@
Who may be able to join
- Age greater than or equal to 18y.
- Self-described Black race. Those with reported other racial backgrounds may enroll in protocol 00-CH-0160 instead.
- Evidence supportive of the diagnosis of PA (e.g. HTN, hypokalemia, known adrenal nodule, elevated ARR, etc).
- Willing and able to return to the NIH for follow-up evaluation.
- Age greater than or equal to 7y.
- Relative of a patient that participates in the main study (above) (i) with family history of hypertension, ACTs, or both, or (ii) with a genetic mutation identified in the course of the genetic investigations described in the main study.
Who cannot join
- Individuals over the age of 70 years will be excluded because of the possibility of comorbidities that may significantly affect appropriate initial work-up and post-operative management. In addition, research data may be compromised by the inability to interpret data collected from patients over the age of 70 years that may be on multiple medications for a variety for reasons.
- Women who are pregnant or nursing will be excluded for safety concerns with hyperaldosteronism workup.
- Individuals whose medical status will not allow them, for safety reasons, to participate in the provocative testing (e.g. NYHA Class III or IV heart failure, or CKD Stage 3b or worse), or who in the opinion of the investigators have unacceptably high risk for surgical morbidity and mortality (e.g. Revised Cardiac Risk Index Class IV or above, or American Society of Anesthesiologists Physical Status Class 3 or above) will be excluded from the protocol, as they will not be able to participate profitably in the research aspects of this protocol.
- Individuals who have current substance abuse or a psychiatric disorder or any other condition that in the opinion of the investigators would impede competence, compliance, or participation in the study.
- Individuals found to have a known inherited syndrome as the cause for hormone over-secretion will be excluded from participation in this protocol, as the mechanisms of hormone over-secretion and tumorigenesis is likely to be distinct in these individuals. Specific examples of syndromes that may be excluded from this protocol include individuals with Carney complex, McCune-Albright syndrome, and MEN-1. If inquiries are received from such patients, they will be referred to the appropriate ongoing protocols, if possible.
- Family members who end up being diagnosed with PA will be referred to the 00-CH-0160 protocol, to avoid selection bias in genetic mutation analyses for PA.
Show all 9Show fewer
- Patients unwilling or unable to abide by procedures of the protocol.
- <TAB>
- -Patients unwilling or unable to provide peripheral blood for DNA studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
Background:
The adrenal gland makes the hormone aldosterone. This helps regulate blood pressure. An adrenal gland tumor that makes too much aldosterone can cause high blood pressure and low potassium. The cause of these tumors is unknown, but sometimes they are inherited.
Read more
Objective:
To study the genes that may cause primary aldosteronism in Black individuals.
Eligibility:
People ages 18-70 who:
Are Black, African American, or of Caribbean descent
And have difficult to control blood pressure or primary aldosteronism
Relatives of people with primary aldosteronism
Design:
Participants who are relatives of people with primary aldosteronism will have only 1 visit, with medical history and blood tests.
Participants with primary aldosteronism or difficult to control blood pressure (suspected to possibly have primary aldosteronism) will be screened with a 1-2 hour visit. If they qualify, they will return for a hospital stay for 7-10 days. Tests may include:
Medical history
Physical exam
Blood tests: Participants will have a small tube (IV catheter) inserted in a vein in the arm. They may drink a glucose-containing liquid or get a salt solution. If medically indicated, they may have invasive blood tests with a separate consent.
Urine tests: Some require a high-salt diet for 3 days.
Heart tests
Scans: Participants lie in a machine that takes pictures of the body. A dye may be injected through a vein.
Small hair sample taken from near the scalp.
Kidney ultrasound
Bone density scan: Participants lie on a table while a camera passes over the body.
If the doctors feel it is medically necessary, they will offer participants treatment depending on their results. These treatments may cure the patient of their disease and may include:
- Having one adrenal gland removed by the Endocrine surgeon under anesthesia. Patients will have follow-up visits 2-4 weeks after surgery.
- Taking drugs to block the effects of aldosterone
Participants may return about 1 year later to repeat testing....
Read the detailed description
Primary Aldosteronism (PA) is the most common cause of secondary hypertension, accounting for 6-8% of hypertension and 14-25% of resistant hypertension. This prevalence translates to approximately 1 in 30-50 adults or about 4,000,000 Americans with PA. Until recently, the deleterious effects of PA were thought to derive solely from aldosterone-mediated sodium retention and associated blood pressure rise. However, animal studies and clinical trials demonstrate that mineralocorticoid receptor (MR) blockade has cardio- and reno-protective effects that clearly exceed those expected from blood pressure reduction alone. Growing evidence supports the concept that excess aldosterone, in the presence of elevated blood pressure, initiates a cascade characterized by fibrosis, oxidative stress, and activation of pro-inflammatory and pro-fibrotic pathways, leading to morbidity via worsened insulin sensitivity, impaired bone formation, and accelerated cardiovascular remodeling. Recent studies have identified several new genetic underpinnings of PA, both germline and somatic, including mutations in KCNJ5, ATP1A1, ATP2B3, CACNA1D, and ARMC5. As the effects of chronic hyperaldosteronism differ between races, it is not surprising that the relative prevalence of these mutations differs among cohorts. African Americans (AA) in particular have increased susceptibility to end-organ damage from aldosterone excess-induced cardiovascular remodeling. They are more likely to have congestive heart failure, end-stage renal disease, and atherosclerotic events than age-matched Caucasians. However, to date no comprehensive analysis of mutations in PA has been performed in AA. (Note: for the purposes of this protocol, the terms Black or African American incorporate individuals who self-identify as Black, African American, or the Caribbean diaspora).
The aims of this study are to identify the germline and/or somatic mutations causing PA in AA, define the effects of these mutations on aldosterone production in AA, and to identify effective pharmacologic agents that will inhibit inappropriate aldosterone production in target cells. Aldosterone producing adenoma (APA) and other adrenocortical tumor (ACT) specimens will be gathered from archival (collected under protocol 00-CH-160 and other related NIH studies) and prospective research subjects with PA that will be evaluated at the NIH Clinical Research Center under the proposed protocol. Samples will be analyzed using state-of-the-art next-generation sequencing (NGS). Human adrenal cell lines (H295R and others, as appropriate) will be used to study the mutations effect on aldosterone production. Additionally, this will help identify possible effective pharmacologic therapeutics to treat PA. Animal models of novel genetic causes of PA may also be created to study the molecular mechanisms underpinning the disease.
- Conditions
- Adrenal Gland Neoplasm, Hypertension, Bone Diseases, Metabolic, Cardiovascular Disease, Hyperinsulinemia
- Keywords
- Adrenal Adenoma, Molecular Genetics, African-American, Biomarkers, Primary Aldosteronism, Natural History
- Medical subject headings
- Adrenal Gland Neoplasms, Hypertension, Bone Diseases, Metabolic, Cardiovascular Diseases, Hyperinsulinism, ACTH Syndrome, Ectopic, Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult AA with primary aldosteronism | Adult individuals (age 18 or older) with HTN and discrete adrenal masses or bilateral hyperplasia of the adrenal glands, with outpatient positive ARR or string clinical suspicion for PA | |
| Family members age >= 7 of participants | DNA from relatives of patients (age 7 or older) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the germline and/or somatic genetic events causing Primary Aldosteronism (PA) in Blacks.
define the causes of PA in AA and develop new therapeutic strategies to inhibit the inappropriate aldosterone production.
Measured: baseline, end of study
To define the effects of mutations in Black subjects on adrenocortical tumor formation, function and aldosterone production.
define the causes of PA in AA and develop new therapeutic strategies to inhibit the inappropriate aldosterone production.
Measured: Continuous
Secondary outcomes (3)
To investigate the clinical utility of other biomarkers in the subtype classification of PA.
define the causes of PA in AA and develop new therapeutic strategies to inhibit the inappropriate aldosterone production.
Measured: baseline, end of study
To investigate the cardiovascular, renal, metabolic, bone, and coagulopathic consequences of PA in AA, as well as any changes after one year of directed therapeutic intervention (e.g. post-adrenalectomy or mineralocorticoid receptor antagonist t...
define the causes of PA in AA and develop new therapeutic strategies to inhibit the inappropriate aldosterone production.
Measured: baseline, end of study
To investigate co-secretion of other steroids in PA.
define the causes of PA in AA and develop new therapeutic strategies to inhibit the inappropriate aldosterone production.
Measured: baseline, end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start14 Dec 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal Gland NeoplasmStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sanaz Sakiani, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374215
- Sponsor's protocol ID
- 180031
- Other IDs
- 18-CH-0031
- Status last verified
- 1 Jul 2026
- First submitted
- 14 Dec 2017
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
- ClinicalTrials.gov ID
- NCT03374215
- Acronym / sponsor ID
- 180031
- Conditions
- Adrenal Gland Neoplasm, Hypertension, Bone Diseases, Metabolic, Cardiovascular Disease, Hyperinsulinemia
- Keywords
- Adrenal Adenoma, Molecular Genetics, African-American, Biomarkers, Primary Aldosteronism, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Dec 2017 (actual)
- 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.
Background:
The adrenal gland makes the hormone aldosterone. This helps regulate blood pressure. An adrenal gland tumor that makes too much aldosterone can cause high blood pressure and low potassium. The cause of these tumors is unknown, but sometimes they are inherited.
Objective:
To study the genes that may cause primary aldosteronism in Black individuals.
Eligibility:
People ages 18-70 who:
Are Black, African American, or of Caribbean descent
And have difficult to control blood pressure or primary aldosteronism
Relatives of people with primary aldosteronism
Design:
Participants who are relatives of people with primary aldosteronism will have only 1 visit, with medical history and blood tests.
Participants with primary aldosteronism or difficult to control blood pressure (suspected to possibly have primary aldosteronism) will be screened with a 1-2 hour visit. If they qualify, they will return for a hospital stay for 7-10 days. Tests may include:
Medical history
Physical exam
Blood tests: Participants will have a small tube (IV catheter) inserted in a vein in the arm. They may drink a glucose-containing liquid or get a salt solution. If medically indicated, they may have invasive blood tests with a separate consent.
Urine tests: Some require a high-salt diet for 3 days.
Heart tests
Scans: Participants lie in a machine that takes pictures of the body. A dye may be injected through a vein.
Small hair sample taken from near the scalp.
Kidney ultrasound
Bone density scan: Participants lie on a table while a camera passes over the body.
If the doctors feel it is medically necessary, they will offer participants treatment depending on their results. These treatments may cure the patient of their disease and may include:
- Having one adrenal gland removed by the Endocrine surgeon under anesthesia. Patients will have follow-up visits 2-4 weeks after surgery.
- Taking drugs to block the effects of aldosterone
Participants may return about 1 year later to repeat testing....
Detailed description
Primary Aldosteronism (PA) is the most common cause of secondary hypertension, accounting for 6-8% of hypertension and 14-25% of resistant hypertension. This prevalence translates to approximately 1 in 30-50 adults or about 4,000,000 Americans with PA. Until recently, the deleterious effects of PA were thought to derive solely from aldosterone-mediated sodium retention and associated blood pressure rise. However, animal studies and clinical trials demonstrate that mineralocorticoid receptor (MR) blockade has cardio- and reno-protective effects that clearly exceed those expected from blood pressure reduction alone. Growing evidence supports the concept that excess aldosterone, in the presence of elevated blood pressure, initiates a cascade characterized by fibrosis, oxidative stress, and activation of pro-inflammatory and pro-fibrotic pathways, leading to morbidity via worsened insulin sensitivity, impaired bone formation, and accelerated cardiovascular remodeling. Recent studies have identified several new genetic underpinnings of PA, both germline and somatic, including mutations in KCNJ5, ATP1A1, ATP2B3, CACNA1D, and ARMC5. As the effects of chronic hyperaldosteronism differ between races, it is not surprising that the relative prevalence of these mutations differs among cohorts. African Americans (AA) in particular have increased susceptibility to end-organ damage from aldosterone excess-induced cardiovascular remodeling. They are more likely to have congestive heart failure, end-stage renal disease, and atherosclerotic events than age-matched Caucasians. However, to date no comprehensive analysis of mutations in PA has been performed in AA. (Note: for the purposes of this protocol, the terms Black or African American incorporate individuals who self-identify as Black, African American, or the Caribbean diaspora).
The aims of this study are to identify the germline and/or somatic mutations causing PA in AA, define the effects of these mutations on aldosterone production in AA, and to identify effective pharmacologic agents that will inhibit inappropriate aldosterone production in target cells. Aldosterone producing adenoma (APA) and other adrenocortical tumor (ACT) specimens will be gathered from archival (collected under protocol 00-CH-160 and other related NIH studies) and prospective research subjects with PA that will be evaluated at the NIH Clinical Research Center under the proposed protocol. Samples will be analyzed using state-of-the-art next-generation sequencing (NGS). Human adrenal cell lines (H295R and others, as appropriate) will be used to study the mutations effect on aldosterone production. Additionally, this will help identify possible effective pharmacologic therapeutics to treat PA. Animal models of novel genetic causes of PA may also be created to study the molecular mechanisms underpinning the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult AA with primary aldosteronism | – | –Adult individuals (age 18 or older) with HTN and discrete adrenal masses or bilateral hyperplasia of the adrenal glands, with outpatient positive ARR or string clinical suspicion for PA |
| Family members age >= 7 of participants | – | –DNA from relatives of patients (age 7 or older) |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary clinical, referrals from community physicians@@@
Key inclusion criteria (6 listed)
- Age greater than or equal to 18y.
- Self-described Black race. Those with reported other racial backgrounds may enroll in protocol 00-CH-0160 instead.
- Evidence supportive of the diagnosis of PA (e.g. HTN, hypokalemia, known adrenal nodule, elevated ARR, etc).
- Willing and able to return to the NIH for follow-up evaluation.
- Age greater than or equal to 7y.
Key exclusion criteria (9 listed)
- Individuals over the age of 70 years will be excluded because of the possibility of comorbidities that may significantly affect appropriate initial work-up and post-operative management. In addition, research data may be compromised by the inability to interpret data collected from patients over the age of 70 years that may be on multiple medications for a variety for reasons.
- Women who are pregnant or nursing will be excluded for safety concerns with hyperaldosteronism workup.
- Individuals whose medical status will not allow them, for safety reasons, to participate in the provocative testing (e.g. NYHA Class III or IV heart failure, or CKD Stage 3b or worse), or who in the opinion of the investigators have unacceptably high risk for surgical morbidity and mortality (e.g. Revised Cardiac Risk Index Class IV or above, or American Society of Anesthesiologists Physical Status Class 3 or above) will be excluded from the protocol, as they will not be able to participate profitably in the research aspects of this protocol.
- Individuals who have current substance abuse or a psychiatric disorder or any other condition that in the opinion of the investigators would impede competence, compliance, or participation in the study.
- Individuals found to have a known inherited syndrome as the cause for hormone over-secretion will be excluded from participation in this protocol, as the mechanisms of hormone over-secretion and tumorigenesis is likely to be distinct in these individuals. Specific examples of syndromes that may be excluded from this protocol include individuals with Carney complex, McCune-Albright syndrome, and MEN-1. If inquiries are received from such patients, they will be referred to the appropriate ongoing protocols, if possible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To define the germline and/or somatic genetic events causing Primary Aldosteronism (PA) in Blacks.
Time frame: baseline, end of study
define the causes of PA in AA and develop new therapeutic strategies to inhibit the inappropriate aldosterone production.
To define the effects of mutations in Black subjects on adrenocortical tumor formation, function and aldosterone production.
Time frame: Continuous
define the causes of PA in AA and develop new therapeutic strategies to inhibit the inappropriate aldosterone production.
3 secondary outcomes
To investigate the clinical utility of other biomarkers in the subtype classification of PA.
Time frame: baseline, end of study
To investigate the cardiovascular, renal, metabolic, bone, and coagulopathic consequences of PA in AA, as well as any changes after one year of directed therapeutic intervention (e.g. post-adrenalectomy or mineralocorticoid receptor antagonist t...
Time frame: baseline, end of study
To investigate co-secretion of other steroids in PA.
Time frame: baseline, end of study
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 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Sanaz Sakiani, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Gland Neoplasm and Hypertension, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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.
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?
Contact Lola E Saidkhodjaeva, R.N. ((301) 827-1448, saidkhodjaeval@cc.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define the germline and/or somatic genetic events causing Primary Aldosteronism (PA) in Blacks. (time frame: baseline, end of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.