Actively Recruiting

Age: 7Years - 70Years
All Genders
Healthy Volunteers
NCT03374215

Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks

Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12

1150

Participants Needed

1

Research Sites

472 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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: 1. Having one adrenal gland removed by the Endocrine surgeon under anesthesia. Patients will have follow-up visits 2-4 weeks after surgery. 2. Taking drugs to block the effects of aldosterone Participants may return about 1 year later to repeat testing....

CONDITIONS

Official Title

Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks

Who Can Participate

Age: 7Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Self-identified as Black, African American, or Caribbean descent
  • Evidence supporting a diagnosis of primary aldosteronism (such as high blood pressure, low potassium, adrenal nodule, or elevated aldosterone-renin ratio)
  • Willing and able to return for follow-up evaluation
  • For the blood DNA study: age 7 years or older
  • Relative of a patient participating in the main study with a family history of hypertension, adrenal tumors, or a genetic mutation identified
Not Eligible

You will not qualify if you...

  • Older than 70 years of age
  • Pregnant or nursing women
  • Medical conditions preventing safe participation in provocative testing (such as severe heart failure or advanced kidney disease)
  • High surgical risk based on cardiac risk or anesthesia status
  • Current substance abuse or psychiatric disorders affecting 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 the DNA study: unwilling or unable to provide blood samples for DNA testing

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

L

Lola E Saidkhodjaeva, R.N.

CONTACT

S

Sanaz Sakiani, M.D.

CONTACT

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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