NIH launches study to uncover genetic roots of Hormone-Driven high blood pressure in black communities

NCT ID NCT03374215

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First seen Jun 26, 2026 · Last updated Sep 09, 2026 · Updated 10 times

Summary

This study aims to find the genetic causes of primary aldosteronism, a condition where adrenal tumors cause high blood pressure, in Black individuals. Researchers will enroll 1150 participants, including those with difficult-to-control blood pressure or known primary aldosteronism, as well as their relatives. Participants undergo blood tests, scans, and other evaluations to identify genetic mutations and their effects on health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could reveal genetic causes of primary aldosteronism in Black individuals, leading to better treatments or prevention strategies.
What could go wrong
This is an observational study, not a treatment trial. It may not directly benefit participants, and findings may take years to translate into clinical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2017

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Primary clinical, referrals from community physicians@@@

Ages

7 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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