NCT03484130

Prospective Phenotyping of Autonomous Aldosterone Secretion

Prospective Phenotyping of Autonomous Aldosterone Secretion: A Cohort Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

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. Primary aldosteronism is a common cause of hypertension and has a relatively high prevalence. This is important since the excessive mineralocorticoid receptor activation in primary aldosteronism contributes to adverse cardiovascular and renal outcomes and death. For these reasons, it is critical that autonomous aldosteronism be detected early in its course since appropriate treatment interventions may prevent cardiovascular disease. In addition to severe and overt primary aldosteronism in hypertension, human studies have shown that milder forms of primary aldosteronism can exist even among normotensive individuals. Detailed physiologic studies have shown that normotensive individuals with a phenotype of autonomous aldosterone secretion have greater cardiometabolic risk factors, impaired renal-vascular function, and a higher risk for developing incident hypertension. Further, older age is associated with greater autonomous aldosterone secretion, suggesting that autonomous aldosterone secretion may progress over time. A better understanding of the prevalence and progression of this type of "subclinical" autonomous aldosterone secretion may inform our understanding of the pathogenesis of hypertension and cardiometabolic diseases. This protocol is designed to be a prospective longitudinal study that will carefully characterize the degree of autonomous aldosterone secretion among high-risk normotensive individuals and follow them longitudinally with repeated phenotyping study visits to assess the progression and severity of autonomous aldosterone secretion over time and its relevance to cardiovascular health. Phenotyping visits will include measurements of the renin-angiotensin-aldosterone system under controlled posture and variable sodium intakes and repeated assessments of blood pressure. This prospective cohort study will provide insights into normal and abnormal aldosterone physiology over time and how it may contribute to time- or age-dependent hypertension and cardiometabolic risk.

Conditions

• Aldosterone Disorder
• Adrenal Gland Disease
• Blood Pressure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sodium loaded diet	At baseline, and annually, participants will undergo aldosterone dynamic testing after \~5 days of a sodium loaded diet. The diet will consist of \>180 mmol/day of sodium, \~50 mmol/day of potassium, and 600mg/d of calcium.
DIETARY_SUPPLEMENT	Restricted sodium diet	At baseline, and annually, participants will undergo aldosterone dynamic testing after \~5 days of a sodium restricted diet. The diet will consist of \<40 mmol/day of sodium, \~50 mmol/day of potassium, and 600mg/d of calcium.

Timeline

• Start date: 2018-06-15
• Primary completion: 2026-04-01
• Completion: 2029-07-01
• First posted: 2018-03-30
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States