New Screening and Diagnostic Cut-off Points of PA Patients

NCT06571084 | Recruiting

• 1 other identifier: 2023-2260
• Study Type: observational
• Target: 770
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Aldosteronism

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Preliminary confirmation positive for primary aldosteronism

  Aldosterone ≥ 85pg/ml after sitting saline test

  1 month

Study Arms (1)

suspected PA

Patients with a high risk for PA who were willing to participate in the study were recruited. The inclusion criteria1 were as follows: 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); or status as a hypertensive first-degree relative of patients with PA; patients with hypertension and obstructive sleep apnea.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-75 years old and highly suspected primary aldosteronism will be included. Patients will be excluded if who is secondary hypertension other than PA, chronic cardiac dysfunction (NYHA III-IV), medium and several kidney dysfunction (Ccr\<30ml/min), with history of liver cirrhosis, oncosis and recent use of steroids or oral contraceptives, pregnant or lactating.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Beijing Anzhen Hospital: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Wuhan Asia Heart Hospital: collaborator

Study Sites (1)

Kai-juan Wang

Beijing, 100037, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

All EDTA plasma and some urine samples were stored at -80℃.

MeSH Terms

Conditions

Hyperaldosteronism; Disease

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Cai

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

• Zhou Zhou

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Central Study Contacts

Jun Cai

CONTACT

caijun7879@126.com

Zhou Zhou

CONTACT

+86 10 88398055; zhouzhou@fuwaihospital.org

Study Design

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

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: January 4, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 31, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)