RecruitingNCT03374215

Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks


Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Enrollment

1,150 participants

Start Date

Dec 14, 2017

Study Type

OBSERVATIONAL

Conditions

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. 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.


Eligibility

Min Age: 7 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a condition called primary aldosteronism — where one or both adrenal glands produce too much of a hormone that raises blood pressure — specifically in Black individuals, to understand how this condition presents and is best managed in this population. **You may be eligible if...** - You are 18 years or older - You self-identify as Black - You have evidence supporting a diagnosis of primary aldosteronism (such as high blood pressure, low potassium levels, an adrenal gland nodule, or abnormal hormone test results) - You are willing and able to return to the NIH for follow-up visits - Family members aged 7 or older with a relevant family history may also be eligible for a separate blood sample portion of the study **You may NOT be eligible if...** - You do not self-identify as Black (a separate related study may be available) - You do not have evidence suggesting primary aldosteronism Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT03374215


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