New Screening and Diagnostic Cut-off Points of PA Patients

Recruiting

• Conditions: Primary Aldosteronism

• Registration Number: NCT06571084
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

This study aims to establish the screening and diagnostic cut-off points for primary aldosteronism patients by a novel small molecule "sandwich method" aldosterone and renin chemiluminescent immunoassay.

Detailed Description

Primary aldosteronism (PA) is the most common causes of secondary hypertension. The diagnostic workup for PA is composed of multiple steps and requires measurement of both plasma aldosterone and renin. In terms of assay of aldosterone, most of currently available chemiluminescence assays are based on competitive methods. What is actually detected is the sum of aldosterone and its metabolite aldosterone 3C glucuronide, which causes the value to be about 50%\~100% higher than the actual value. This study aims to establish a new ARR (aldosterone/renin ratio) cutoff point for PA screening and a new cutoff point for PA diagnosis, using a recently developed two-site sandwich chemiluminescence method (Snibe, China) for aldosterone and renin assay.

Hypertensive patients referred to hospitals for screening of PA will be included. All the participants proceed to seated saline infusion test (SIT) and captopril challenge test (CCT) for confirmation. Aldosterone and renin will be measured using chemiluminescent immunoassay on the Liaison analyzer (DiaSorin, Italy) and MAGLUMI X8 (Snibe, China), as well as liquid chromatography-tandem mass spectrometry (LC-MS/MS) platform. According to the experience of Fuwai Hospital, the following diagnosis criteria are proposed: Based on the results of currently used (DiaSorin, Italy), aldosterone \> 8.5ng/dL and renin \< 15μIU/mL after sitting saline infusion conform PA, and aldosterone ≤ 8.5ng/dL excludes PA.

The total number of cases to be enrolled in this study is planned to be 770, including at least 77 positive subjects and at least 406 negative subjects. By drawing the ROC curve, the point corresponding to the maximum value of the Youden index will be selected as the cutoff value, and the corresponding sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, etc. will be calculated.

Study Timeline

• Study Start: 2024-01-04
• Status Verified: 2024-08
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Primary Completion: 2024-10
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 770

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preliminary confirmation positive for primary aldosteronism	1 month	Aldosterone ≥ 85pg/ml after sitting saline test

Trial Locations

Locations (1)

Kai-juan Wang; 🇨🇳 Beijing, China