Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
2 other identifiers
observational
1,150
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2017
CompletedStudy Start
First participant enrolled
December 14, 2017
CompletedFirst Posted
Study publicly available on registry
December 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 24, 2026
July 17, 2025
9.1 years
December 14, 2017
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To define the germline and/or somatic genetic events causing Primary Aldosteronism (PA) in Blacks.
define the causes of PA in AA and develop new therapeutic strategies to inhibit the inappropriate aldosterone production.
baseline, end of study
To define the effects of mutations in Black subjects on adrenocortical tumor formation, function and aldosterone production.
define the causes of PA in AA and develop new therapeutic strategies to inhibit the inappropriate aldosterone production.
Continuous
Secondary Outcomes (3)
To investigate the clinical utility of other biomarkers in the subtype classification of PA.
baseline, end of study
To investigate the cardiovascular, renal, metabolic, bone, and coagulopathic consequences of PA in AA, as well as any changes after one year of directed therapeutic intervention (e.g. post-adrenalectomy or mineralocorticoid receptor antagonist t...
baseline, end of study
To investigate co-secretion of other steroids in PA.
baseline, end of study
Study Arms (2)
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)
Eligibility Criteria
Primary clinical, referrals from community physicians@@@
You may qualify if:
- 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.
You may not qualify if:
- 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\>
- Patients unwilling or unable to provide peripheral blood for DNA studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanaz Sakiani, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2017
First Posted
December 15, 2017
Study Start
December 14, 2017
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 24, 2026
Record last verified: 2025-07-17