Establishing new diagnostic cut-off points for primary aldosteronism

Establishment and Clinical Application Evaluation of Screening and Diagnostic Cut-off Points With Aldosterone and Renin for Primary Aldosteronism Patients

This study is trying to find better ways to diagnose primary aldosteronism in people with high blood pressure by testing new cut-off points for hormone levels.

Quick facts

• Study type: Observational
• Enrollment: 770 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 1 site (Beijing)
• Trial ID: NCT06571084 on ClinicalTrials.gov

What this trial studies

This observational study aims to determine new screening and diagnostic cut-off points for primary aldosteronism (PA) using a novel two-site sandwich chemiluminescence method for measuring aldosterone and renin levels. Patients with persistent or resistant hypertension will undergo a series of tests, including seated saline infusion and captopril challenge tests, to confirm PA. The study seeks to improve the accuracy of PA diagnosis by establishing a new aldosterone/renin ratio cutoff point, addressing limitations of current diagnostic methods that may overestimate aldosterone levels.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with persistent or resistant hypertension or specific hypertension-related conditions.

Not a fit: Patients with secondary hypertension unrelated to primary aldosteronism or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses of primary aldosteronism, allowing for better-targeted treatments for patients.

How similar studies have performed: While there have been studies on primary aldosteronism, this approach using a novel assay method is relatively new and may provide unique insights.

Eligibility criteria

Inclusion Criteria:

* 18-75y;
* persistent hypertension (BP \>150/100 mm Hg), or drug-resistant hypertension;
* newly diagnosed hypertension;
* hypertension and spontaneous or diuretic-induced hypokalemia;
* hypertension with adrenal incidentaloma;
* hypertension and a family history of early-onset hypertension or cerebrovascular accident at a young age (\<40 years);
* status as a hypertensive first-degree relative of patients with PA;
* patients with hypertension and obstructive sleep apnea.

Exclusion Criteria:

* age \<18; BMI ≤ 18.0kg/m2 or ≥ 35.0 kg/m2;
* a diagnosis of secondary hypertension other than PA;
* chronic cardiac dysfunction (NYHA III-IV);
* medium and several kidney dysfunction (Ccr\<30ml/min);
* liver cirrhosis;
* terminal malignant tumor;
* recent use of steroids or oral contraceptives;
* pregnancy or lactation.

Where this trial is running

Beijing

• Kai-juan Wang — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jun Cai

Conditions Primary Aldosteronism; aldosterone; renin; cut-off value; diagnosis