Status:
ACTIVE_NOT_RECRUITING
Prospective Phenotyping of Autonomous Aldosterone Secretion
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Aldosterone Disorder
Adrenal Gland Disease
Eligibility:
All Genders
35-70 years
Brief Summary
This prospective cohort study will investigate the physiology and progression of autonomous aldosterone secretion.
Detailed Description
Primary aldosteronism is a disorder wherein aldosterone is secreted by the adrenal gland(s) independent of its physiologic regulators and cannot be appropriately suppressed with sodium/volume loading....
Eligibility Criteria
Inclusion
- Age 35-70 years
- Systolic blood pressure of 120-135 mmHg and/or diastolic blood pressure of 75-85 mmHg
- At least one, or more, of the following:
- BMI ≥ 25 kg/m2
- Family history of hypertension prior to the age of 60 years in a parent or sibling
- Diabetes with a hemoglobin A1c \< 9%
- If systolic blood pressure 115-135 mmHg and/or diastolic blood pressure 70-85 mmHg, must have two or more of the following:
- BMI ≥ 25 kg/m2
- Family history of hypertension prior to the age of 60 years in a parent or sibling
- Diabetes with a hemoglobin A1c \< 9%
Exclusion
- Known history of hypertension or use of antihypertensive medications
- Known history of stroke, coronary artery disease, myocardial infarction, heart failure, cerebral or aortic aneurysm, or preeclampsia.
- Active cancer that is being treated with chemotherapeutic agents
- Pregnancy
- Breast feeding
- Daily use of prescribed opioid medications
- Illicit drug use (cocaine, heroin, methamphetamine)
- Daily non-steroidal anti-inflammatory medication use
- Daily use of glucocorticoids
- Electrocardiogram that shows evidence of prior myocardial infarction, atrial arrhythmia, left or right bundle branch blocks.
- Estimated glomerular filtration rate \< 60 mL/min/1.73m2
- Active and untreated hyper- or hypo-thyroidism
- Abnormal screening laboratories (comprehensive metabolic panel, complete blood count, thyrotropin)
- BMI ≥ 45 kg/m2
Key Trial Info
Start Date :
June 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03484130
Start Date
June 15 2018
End Date
July 1 2029
Last Update
October 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115