Status:
RECRUITING
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Adrenal Gland Neoplasm
Hypertension
Eligibility:
All Genders
7-70 years
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...
Detailed Description
Primary Aldosteronism (PA) is the most common cause of secondary hypertension, accounting for 6-8% of hypertension and 14-25% of resistant hypertension. This prevalence translates to approximately 1 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
1150 Patients enrolled
Trial Details
Trial ID
NCT03374215
Start Date
December 14 2017
End Date
December 31 2025
Last Update
January 5 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892