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Completed

NCT Number: NCT05757076

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

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. 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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood test for ARR

Procedure

Blood test for calculating aldosterone and renin ratio (ARR)

Primary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: ARR

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2023
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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