Recruiting

Observational Study

Sponsor:

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

Code:

NCT03374215

Conditions

Adrenal Gland Neoplasm

Hypertension

Bone Diseases, Metabolic

Cardiovascular Disease

Hyperinsulinemia

Eligibility Criteria

Sex: All

Age: 7 - 70

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Adrenal Gland Neoplasm

Hypertension

Bone Diseases, Metabolic

Cardiovascular Disease

Hyperinsulinemia

Study ID

NCT03374215

Start date

Dec 14, 2017

Status verified date

Jul 1, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 70

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

Inclusion criteria for main study:

  • 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.

Inclusion criteria for blood (peripheral) DNA only study:

  • 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 CRITERIA:

Exclusion criteria for main study:

  • 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.

<TAB>

Exclusion criteria for the DNA only study:

-Patients unwilling or unable to provide peripheral blood for DNA studies.

Study Design

Enrollment

1150 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Primary outcome measure

  • To define the germline and/or somatic genetic events causing Primary Aldosteronism (PA) in Blacks. [ Time Frame: baseline, end of study ]
  • To define the effects of mutations in Black subjects on adrenocortical tumor formation, function and aldosterone production. [ Time Frame: Continuous ]

Central Contacts and Locations

Central contacts

Lola E Saidkhodjaeva, R.N.

(301) 827-1448saidkhodjaeval@cc.nih.gov

Sanaz Sakiani, M.D.

(301) 443-7743sanaz.sakiani@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

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

Last update posted

Sep 8, 2026

Last verified

Jul 1, 2026

Keywords

  • Adrenal Adenoma
  • Molecular Genetics
  • African-American
  • Biomarkers
  • Primary Aldosteronism
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on 2026-09-08.