Exploring genetic factors of primary aldosteronism in Black individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the clinical and molecular characteristics of primary aldosteronism, particularly focusing on Black individuals. Participants aged 18-70 with difficult-to-control blood pressure or primary aldosteronism will undergo a series of evaluations, including medical history assessments and blood tests. Relatives of individuals with primary aldosteronism will also be included in the study with a single visit for medical history and blood sampling. The research seeks to identify genetic mutations associated with this condition and understand the racial differences in its effects.

Why it matters

Who can join: the full rules

* 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.

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Exclusion criteria for the DNA only study:

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

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Sanaz Sakiani, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Study coordinator: Lola E Saidkhodjaeva, R.N.
• Email: saidkhodjaeval@cc.nih.gov
• Phone: (301) 827-1448

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.