Actively Recruiting
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-06-08
1150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating primary aldosteronism (PA), a condition where the adrenal glands produce too much aldosterone, leading to high blood pressure and low potassium. This study focuses on Black individuals, including African Americans and those of Caribbean descent, who have difficult-to-control hypertension or PA, as well as their relatives. The aim is to identify genetic factors causing PA in this population and understand how these mutations affect aldosterone production and related health effects. Participants with diagnosed or suspected PA will undergo screening visits lasting 1 to 2 hours. Those who qualify will stay in the hospital for 7 to 10 days for thorough testing, including medical history, physical exams, blood and urine tests, heart evaluations, scans with or without dye, kidney ultrasound, bone density scans, and hair sample collection. Relatives of participants will have a single visit for medical history and blood tests. Treatment options offered based on results may include adrenal gland removal or medication to block aldosterone effects, with follow-up visits after surgery. Some participants may return about one year later for repeat testing. During the study, participants will have multiple assessments to monitor their health and the effects of PA, including blood pressure, aldosterone levels, and organ function. Researchers will use advanced genetic sequencing on tumor samples and study adrenal cell lines to evaluate mutation effects. The study will measure outcomes related to tumor formation, aldosterone production, cardiovascular and metabolic health, bone density, and blood clotting. Safety and health observations will continue throughout participation, which may last up to a year or more depending on follow-up visits.
CONDITIONS
Brief Title
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older for main study
- Self-described Black race (including African American or Caribbean descent)
- Evidence supporting diagnosis of primary aldosteronism (such as hypertension, low potassium, adrenal nodule, or elevated aldosterone-renin ratio)
- Willing and able to return for follow-up visits
- Age 7 years or older for relatives in DNA-only study
- Relative of a participant with family history of hypertension or adrenal tumors, or known genetic mutation identified in the main study
You will not qualify if you...
- Age over 70 years
- Pregnant or nursing women
- Medical conditions preventing safe participation in provocative testing (e.g., severe heart failure, advanced kidney disease)
- High surgical risk as judged by investigators
- Current substance abuse, psychiatric disorder, or other conditions impairing study participation
- Known inherited syndromes causing hormone over-secretion (e.g., Carney complex, McCune-Albright syndrome, MEN-1)
- Family members diagnosed with primary aldosteronism (referred to another protocol)
- Unwilling or unable to follow study procedures
- For DNA-only study: unwilling or unable to provide blood samples for genetic testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline to end of study
Participants undergo evaluations including clinical assessments and sample collection to identify genetic mutations and characterize primary aldosteronism.
Multiple visits for clinical assessments and sample collection as scheduled
Duration - Up to 1 year or until study completion
Participants are monitored over time to assess the effects of mutations on health outcomes and response to any directed therapeutic interventions.
Follow-up visits as scheduled up to one year
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
L
Lola E Saidkhodjaeva, R.N.
S
Sanaz Sakiani, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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