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Understanding Primary Aldosteronism in Black Individuals

This observational study aims to understand the genetic causes of Primary Aldosteronism (PA) in Black individuals. PA is a condition where the adrenal glands (small glands above your kidneys) make too much of a hormone called aldosterone, which can lead to high blood pressure and low potassium. Researchers want to identify specific genetic changes, both inherited and new, that contribute to PA in this population. They also want to see how these genetic changes affect the formation and function of adrenal tumors and the production of aldosterone. The study is open to Black individuals aged 18-70 who have high blood pressure or PA, as well as their relatives. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 1150 participants. It is not a randomized or blinded study.
What's involved
Participants who are relatives of people with primary aldosteronism will have only one visit, which includes a medical history and blood tests. Other participants will need to return to the NIH for follow-up evaluations.
Compensation
Not stated in the trial record.
Follow-up
Primary endpoints are measured at baseline and at the end of the study, and continuously for some aspects.

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NCT03374215

Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks

Recruiting
Not specifiedAges 7–70Observational
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
~1,150 participants
Updated 2026-08-24 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To define the germline and/or somatic genetic events causing Primary Aldosteronism (PA) in Blacks.
Measured over baseline, end of study
+1 more outcome measured

Conditions

Adrenal Gland Neoplasm
Hypertension
Bone Diseases, Metabolic
Cardiovascular Disease
Hyperinsulinemia

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Conn Syndrome

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Sanaz Sakiani, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who to contact

Lola E Saidkhodjaeva, R.N.
[email protected]
(301) 827-1448
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.
Patients unwilling or unable to abide by procedures of the protocol.
Patients unwilling or unable to provide peripheral blood for DNA studies.

What this trial measures

  • To define the germline and/or somatic genetic events causing Primary Aldosteronism (PA) in Blacks.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.Continuous

    define the causes of PA in AA and develop new therapeutic strategies to inhibit the inappropriate aldosterone production.