Primary AldosteronismARRNCT05757076
Aldosterone Renin Ratio (ARR) Test to Increase Case-detection of Primary Aldosteronism (PA)
An observational study of Primary Aldosteronism, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The mission of this project is to increase the detection of Primary Aldosteronism (PA), the most common cause of secondary hypertension, which can either be cured surgically or treated with targeted medications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- Blood test for ARR
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2023to 29 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Subjects will be enrolled prospectively, under Institutional Review Board (IRB) approval and patient informed consent. Enrollment will include patients with known hypertension diagnosed via ICD-10 code who are on a single anti-hypertensive medication. Primary Care Physicians will identify potential patients and they will discuss with patients the possibility of participating in the study. The PCP will subsequently refer any potential patients that meet the criteria to the study team. A study coordinator will reach out to the patient via telephone encounter, MyChart message or mail to discuss the study in more detail. . Subjects will be consented in an office visit.
Who may be able to join
- Consent to participate in the study
- Participants limited to subjects in the CCF
- Age between and inclusive of 18 and 65 years of age
- No gender exclusion
- Patients diagnosed with Essential Hypertension by ICD-10 code on at least two occasions in the previous six months, even if not on medications for hypertension
- Patients on a single anti-hypertensive medication for at least six months with the diagnosis of hypertension
Who cannot join
- Those on a mineralocorticoid antagonist therapy (spironolactone, eplerenone)
- Those with a documented diagnosis of primary aldosteronism or primary hyperaldosteronism
- Those with a diagnosis of secondary hyperaldosteronism
- Those with a diagnosis of heart failure, renal artery stenosis, cirrhosis, ascites, cor pulmonale.
- Pregnancy status (verbal)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this study
The mission of this project is to increase the detection of Primary Aldosteronism (PA), the most common cause of secondary hypertension, which can either be cured surgically or treated with targeted medications.
Read the detailed description
The mission of this project is to increase the detection of Primary Aldosteronism (PA), the most common cause of secondary hypertension, which can either be cured surgically or treated with targeted medications. It is caused by the autonomous secretion of aldosterone by the adrenal glands.
Hypertension, elevated adrenal aldosterone secretion, and suppressed renin are the hallmarks of PA. The prevalence of PA varies approximately from 5% up to 20%.
Clinicians continue to erroneously learn that PA is a very rare disorder, thus PA continues to be under-recognized and undertreated. PA is a major public health issue, and the current case-detection rate is much below the prevalence rates reported in studies. Correctly identifying PA in patients will enable effective treatment and potential cure for this disease Hypertension by itself is a major driver of cardiovascular morbidity and mortality. There are ~ 1 billion people diagnosed with hypertension in the world, and even if we take a conservative prevalence of PA of 5% amongst this population, it would yield a staggering number of 50 million.
Cardiovascular and cerebrovascular morbidity and mortality rates are higher in those with PA compared to patients with blood pressure-matched essential hypertension.
As per the current Endocrine Society Guidelines, only patients who meet specific clinical profiles are considered to be candidates for screening for PA. Typically screening involves a blood test for calculating aldosterone and renin ratio (ARR). An abnormal test indicates the possibility of PA. It is estimated that only 1% of patients are detected by these screening guidelines.
Given the underdiagnosed state of this condition, and the high cardiovascular, cerebrovascular, and renal risks it entails, we should broaden the population to be screened for PA. All patients with hypertension who are on at least one anti-hypertensive medication should be screened for PA, especially given the benefits from specific surgical or medical treatment.
This would help reduce disease burden in a cost-effective manner and will impact the Care of Patients
- Conditions
- Primary Aldosteronism
- Being tested
- Blood test for ARR
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test for ARRProcedure or surgery
Blood test for calculating aldosterone and renin ratio (ARR)
| Study group | Role | What they receive |
|---|---|---|
| Screening Cohort | This is a prospective specimen collection cohort study aimed to increase the detection of primary aldosteronism (PA) in patients with hypertension.
Study samples will be obtained longitudinally. One collection of plasma will be obtained. Blood draw may need to be repeated in some subjects after washout period. Study will continue for a period or 1 year, with plan to enroll around 50 subjects. Receives: Procedure: Blood test for ARR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with Primary Aldosteronism (PA) that were missed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start2 May 2023
- Primary completion1 Aug 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757076
- Sponsor's protocol ID
- 23-132
- Acronym
- ARR
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aldosterone Renin Ratio (ARR) Test to Increase Case-detection of Primary Aldosteronism (PA)
- ClinicalTrials.gov ID
- NCT05757076
- Acronym / sponsor ID
- ARR / 23-132
- Conditions
- Primary Aldosteronism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 7 Mar 2023 (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.
The mission of this project is to increase the detection of Primary Aldosteronism (PA), the most common cause of secondary hypertension, which can either be cured surgically or treated with targeted medications.
Detailed description
The mission of this project is to increase the detection of Primary Aldosteronism (PA), the most common cause of secondary hypertension, which can either be cured surgically or treated with targeted medications. It is caused by the autonomous secretion of aldosterone by the adrenal glands.
Hypertension, elevated adrenal aldosterone secretion, and suppressed renin are the hallmarks of PA. The prevalence of PA varies approximately from 5% up to 20%.
Clinicians continue to erroneously learn that PA is a very rare disorder, thus PA continues to be under-recognized and undertreated. PA is a major public health issue, and the current case-detection rate is much below the prevalence rates reported in studies. Correctly identifying PA in patients will enable effective treatment and potential cure for this disease Hypertension by itself is a major driver of cardiovascular morbidity and mortality. There are ~ 1 billion people diagnosed with hypertension in the world, and even if we take a conservative prevalence of PA of 5% amongst this population, it would yield a staggering number of 50 million.
Cardiovascular and cerebrovascular morbidity and mortality rates are higher in those with PA compared to patients with blood pressure-matched essential hypertension.
As per the current Endocrine Society Guidelines, only patients who meet specific clinical profiles are considered to be candidates for screening for PA. Typically screening involves a blood test for calculating aldosterone and renin ratio (ARR). An abnormal test indicates the possibility of PA. It is estimated that only 1% of patients are detected by these screening guidelines.
Given the underdiagnosed state of this condition, and the high cardiovascular, cerebrovascular, and renal risks it entails, we should broaden the population to be screened for PA. All patients with hypertension who are on at least one anti-hypertensive medication should be screened for PA, especially given the benefits from specific surgical or medical treatment.
This would help reduce disease burden in a cost-effective manner and will impact the Care of Patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening Cohort | – | Procedure: Blood test for ARRThis is a prospective specimen collection cohort study aimed to increase the detection of primary aldosteronism (PA) in patients with hypertension. Study samples will be obtained longitudinally. One collection of plasma will be obtained. Blood draw may need to be repeated in some subjects after washout period. Study will continue for a period or 1 year, with plan to enroll around 50 subjects. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects will be enrolled prospectively, under Institutional Review Board (IRB) approval and patient informed consent. Enrollment will include patients with known hypertension diagnosed via ICD-10 code who are on a single anti-hypertensive medication. Primary Care Physicians will identify potential patients and they will discuss with patients the possibility of participating in the study. The PCP will subsequently refer any potential patients that meet the criteria to the study team. A study coordinator will reach out to the patient via telephone encounter, MyChart message or mail to discuss the study in more detail. . Subjects will be consented in an office visit.
Key inclusion criteria (6 listed)
- Consent to participate in the study
- Participants limited to subjects in the CCF
- Age between and inclusive of 18 and 65 years of age
- No gender exclusion
- Patients diagnosed with Essential Hypertension by ICD-10 code on at least two occasions in the previous six months, even if not on medications for hypertension
Key exclusion criteria (5 listed)
- Those on a mineralocorticoid antagonist therapy (spironolactone, eplerenone)
- Those with a documented diagnosis of primary aldosteronism or primary hyperaldosteronism
- Those with a diagnosis of secondary hyperaldosteronism
- Those with a diagnosis of heart failure, renal artery stenosis, cirrhosis, ascites, cor pulmonale.
- Pregnancy status (verbal)
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 |
|---|---|---|
| Blood test for ARRBlood test for calculating aldosterone and renin ratio (ARR) | Procedure or surgery | Screening Cohort |
Primary outcome
Percentage of patients with Primary Aldosteronism (PA) that were missed.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Primary Aldosteronism, run by The Cleveland Clinic 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 23 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients with Primary Aldosteronism (PA) that were missed. (time frame: 1 year). 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 23 Feb 2026.