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Completed

NCT Number: NCT04193137

Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism

To compare the diagnostic value of three confirmatory tests for primary aldosteronism.

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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Endocrine System Diseases Hyperaldosteronism

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qifu Li

Chongqing, Chongqing Municipality, 400016, China

About this study

This is a prospective study involving 240 hypertensive patients who underwent primary aldosteronism screening. Every patient will undertake four confirmatory tests to compare the diagnostic accuracy of the oral sodium loading test with captopril challenge testing (CCT) and Seated saline infusion test(SSST)using the fludrocortisone suppression testing (FST) as the reference standard, and to investigate the optimal cutoff of oral sodium loading test

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • hypertensive patients with ARR≥10(pg/ml)(uIU/ml)
  • hypertensive patients with ARR<10(pg/ml)(uIU/ml) but suspicious of PA clinically

Exclusion criteria

  • Pregnancy or lactation;
  • Child-bearing women refuse to take effective contraceptive measures;
  • History of malignant tumor;
  • Patients with cardiovascular and cerebrovascular diseases (eg. myocardial infarction, acute heart failure, stroke), in the past 3 months
  • NYHA III (New York Heart Association)and above
  • Hypohepatia
  • Chronic kidney disease with an estimated Glomerular Filtration Rate <30ml/min/1.73 m²
  • Severe arrhythmia by ECG or severe heart disease by cardiac ultrasound
  • Patients who are unwilling to participate in and complete this study and refuses to sign the informed consent form for this study

Treatment and study plan

Oral sodium loading test,Seated saline infusion test and Captopril challenge test

Diagnostic Test

Oral sodium loading test : Patients received 6g oral sodium every day for 3 days.

Seated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture.

Captopril challenge test: Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 2 h. Blood samples were drawn at time zero and 2 h after the challenge.

Primary outcomes

  1. Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test

    Time frame: 9 days

    sensitivity, specificity and area under curve (AUC)

Secondary outcomes

  1. the optimal cutoff value of urine aldosterone in oral sodium test

    Time frame: 3 days

    urine aldosterone

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

Comparison of Saline Infusion Test, Captopril Challenge Test, and Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 10, 2019
Registry last updated
Aug 4, 2021

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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