Aldosterone DisorderNCT03484130
Prospective Phenotyping of Autonomous Aldosterone Secretion
An observational study of Aldosterone Disorder and Adrenal Gland Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This prospective cohort study will investigate the physiology and progression of autonomous aldosterone secretion. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aldosterone Disorder, Adrenal Gland Disease, Blood Pressure
- What is being tested?
- Sodium loaded diet and Restricted sodium diet
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 1 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normotensive individuals who have a reasonably high risk of developing hypertension in the next few years
Who may be able to join
- 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%
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- 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%
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Prospective Phenotyping of Autonomous Aldosterone Secretion: A Cohort Study
This prospective cohort study will investigate the physiology and progression of autonomous aldosterone secretion.
Read the 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
- Being tested
- Sodium loaded diet, Restricted sodium diet
- Keywords
- primary aldosteronism
- Medical subject headings
- Adrenal Gland Diseases, Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Sodium loaded diet; Dietary Supplement: Restricted sodium diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in renin
The primary outcome is to evaluate the longitudinal change in plasma renin activity
Measured: 10 years
Secondary outcomes (2)
SASSI
The longitudinal change in the sodium modulated suppression-to-stimulation index
Measured: 5 years
Blood pressure
Longitudinal changes in blood pressure
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start15 Jun 2018
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aldosterone DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Anand Vaidya, Brigham and Women's Hospital
- Investigators
- Anand Vaidya, MD, MMSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484130
- Sponsor's protocol ID
- 2018P000257
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2018
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phenotyping of Autonomous Aldosterone Secretion: A Cohort Study
- ClinicalTrials.gov ID
- NCT03484130
- Acronym / sponsor ID
- 2018P000257
- Conditions
- Aldosterone Disorder, Adrenal Gland Disease, Blood Pressure
- Keywords
- primary aldosteronism
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Risk Normotensives | – | Dietary Supplement: Sodium loaded diet, Dietary Supplement: Restricted sodium dietThese high-risk normotensives are considered to be enriched for subclinical autonomous aldosterone secretion and have a high risk for developing incident hypertension |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normotensive individuals who have a reasonably high risk of developing hypertension in the next few years
Key inclusion criteria (10 listed)
- 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:
- If systolic blood pressure 115-135 mmHg and/or diastolic blood pressure 70-85 mmHg, must have two or more of the following:
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium loaded dietAt 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 | High-Risk Normotensives |
| Restricted sodium dietAt 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. | Dietary supplement | High-Risk Normotensives |
Primary outcome
Change in renin
Time frame: 10 years
The primary outcome is to evaluate the longitudinal change in plasma renin activity
2 secondary outcomes
SASSI
Time frame: 5 years
Blood pressure
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Aldosterone Disorder
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Effect of an Isolevuglandin Scavenger on Salt Sensitivity of Blood Pressure and Immune Cell Activation in Humans
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EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
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Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study.
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REFOCUS-HTN US-WEST: A Data Infrastructure to Characterize Individuals With Hypertension
Hypertension, Aldosterone Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anand Vaidya, MD, MMSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aldosterone Disorder and Adrenal Gland Disease, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in renin (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.