Aldosterone Renin Ratio (ARR) Test to Increase Case-detection of Primary Aldosteronism (PA)

NCT ID: NCT05757076

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2025-12-29

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Blood test for ARR

Intervention Type: PROCEDURE

Blood test for calculating aldosterone and renin ratio (ARR)

Interventions

Blood test for ARR

Blood test for calculating aldosterone and renin ratio (ARR)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

23-132

Identifier Type: -

Identifier Source: org_study_id