Optimizing Diagnosis Of Primary Aldosteronism

Completed

• Conditions: Primary Aldosteronism

• Registration Number: NCT02755519
• Lead Sponsor: Chongqing Medical University

Brief Summary

To optimize the confirmatory tests for primary aldosteronism.

Detailed Description

In this study, the investigators aim to optimize the three confirmatory tests: salt loading, captopril challenge and fludrocortisone suppression, and to confirm a better choice of confirming testing for single or combined diagnosis of primary aldosteronism. Additionally, the investigators plan to collect blood and tissue samples of PA patients for genetic testing, and to proceed a long-term follow-up for further investigating the mechanism underlying PA and evaluating the cardio-cerebrovascular complications risk.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2016-04-08
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-29
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-10
• Last Update Posted: 2016-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• With hypertension;
• With adrenal diseases

Exclusion Criteria

• Pregnant or during lactation period;
• Under 18 yr;
• BMI ≤ 19 or ≥ 35
• With Cancer medical history
• Been through cardiovascular diseases in the past 3 months;
• Been through malignant arrhythmia, respiratory muscle paralysis or skeletal muscle paralysis caused by hypokalemia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the receiver operating characteristic curve (AUC) for Salt loading test	1 week	Salt loading test will be performed and compared to golden standard such as adrenal venous sampling (AVS) and biopsy results. The area under the curve (AUC) will be calculated.
AUC for fludrocortisone suppression test	1 week	Fludrocortisone suppression test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.
AUC for captopril challenge test	1 week	Captopril challenge test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.

Secondary Outcome Measures

Name	Time	Method
Incidence of cardiovascular diseases in Primary Aldosteronism	3 years	Follow-up for the risk of cardiovascular diseases, chronic kidney disease and stroke

Trial Locations

Locations (1)

The First Affilated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China