Study of Prevalence and Clinical Phenotype in Patients With Glucocorticoid-Remediable Aldosteronism
Primary Purpose
Hyperaldosteronism
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Hyperaldosteronism focused on measuring endocrine disorders, genetic diseases and dysmorphic syndromes, hyperaldosteronism, rare disease
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosed glucocorticoid-remediable aldosteronism (GRA) with hypertension Hypokalemia is variably seen Blood pressure variably elevated Elevated level of aldosterone Low level of plasma renin activity
Sites / Locations
- Brigham and Women's Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004354
First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00004354
Brief Title
Study of Prevalence and Clinical Phenotype in Patients With Glucocorticoid-Remediable Aldosteronism
Study Type
Observational
2. Study Status
Record Verification Date
May 2002
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Brigham and Women's Hospital
4. Oversight
5. Study Description
Brief Summary
OBJECTIVES: I. Determine the prevalence of glucocorticoid-remediable aldosteronism (GRA) in various hypertensive populations and screen at risk members of GRA pedigrees.
II. Investigate other factors regulating blood pressure in GRA (environmental, genetically determined factors).
III. Investigate renal and hormonal mechanisms regulating potassium homeostasis in GRA.
IV. Describe clinical phenotype of GRA patients. V. Prospectively screen GRA-affected patients with MRI angiography for intracranial aneurysm.
Detailed Description
PROTOCOL OUTLINE:
Patients are screened for high blood pressure, suppressed plasma renin activity level, and low potassium levels. Urine is collected for a 24 hour period. Blood specimen is collected for molecular biologic evaluation for the presence of the chimeric gene diagnostic of GRA. Any history of cardiovascular events is recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperaldosteronism
Keywords
endocrine disorders, genetic diseases and dysmorphic syndromes, hyperaldosteronism, rare disease
7. Study Design
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Diagnosed glucocorticoid-remediable aldosteronism (GRA) with hypertension Hypokalemia is variably seen Blood pressure variably elevated Elevated level of aldosterone Low level of plasma renin activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G. Dluhy
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Prevalence and Clinical Phenotype in Patients With Glucocorticoid-Remediable Aldosteronism
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