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

NCT05757076 | Completed

• 1 other identifier: 23-132
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Aldosteronism

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with Primary Aldosteronism (PA) that were missed.

  1 year

Study Arms (1)

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.

Procedure: Blood test for ARR

Interventions

Blood test for ARR PROCEDURE

Blood test for calculating aldosterone and renin ratio (ARR)

Screening Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Consent to participate in the study
• Participants limited to subjects in the CCF
• Age between and inclusive of 18 and 65 years of age
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: May 2, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 29, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)