NCT03484130

Brief Summary

This prospective cohort study will investigate the physiology and progression of autonomous aldosterone secretion.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
38mo left

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Jun 2018Jul 2029

First Submitted

Initial submission to the registry

March 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Expected
Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

7.8 years

First QC Date

March 23, 2018

Last Update Submit

October 22, 2025

Conditions

Aldosterone DisorderAdrenal Gland DiseaseBlood Pressure

Keywords

primary aldosteronism

Outcome Measures

Primary Outcomes (1)

  • Change in renin

    The primary outcome is to evaluate the longitudinal change in plasma renin activity

    10 years

Secondary Outcomes (2)

  • SASSI

    5 years

  • Blood pressure

    5 years

Study Arms (1)

High-Risk Normotensives

These high-risk normotensives are considered to be enriched for subclinical autonomous aldosterone secretion and have a high risk for developing incident hypertension

Dietary Supplement: Sodium loaded dietDietary Supplement: Restricted sodium diet

Interventions

Sodium loaded dietDIETARY_SUPPLEMENT

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.

High-Risk Normotensives
Restricted sodium dietDIETARY_SUPPLEMENT

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.

High-Risk Normotensives

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normotensive individuals who have a reasonably high risk of developing hypertension in the next few years

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Adrenal Gland DiseasesHyperaldosteronism

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Endocrine System DiseasesAdrenocortical Hyperfunction

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Anand Vaidya, MD, MMSc

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Adrenal Disorders

Study Record Dates

First Submitted

March 23, 2018

First Posted

March 30, 2018

Study Start

June 15, 2018

Primary Completion

April 1, 2026

Study Completion (Estimated)

July 1, 2029

Last Updated

October 23, 2025

Record last verified: 2025-10

Locations

US(1)