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Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193137
Recruitment Status : Completed
First Posted : December 10, 2019
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
Qifu Li, Chongqing Medical University

Study Description
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Brief Summary:
To compare the diagnostic value of three confirmatory tests for primary aldosteronism.

Condition or disease Intervention/treatment
Primary Aldosteronism Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test

Detailed Description:
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
Study Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Saline Infusion Test, Captopril Challenge Test, and Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism
Actual Study Start Date : November 30, 2019
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : June 30, 2021

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Primary Aldosteronism(PA)
plasma aldosterone /renin ratio (ARR)>10 pg/μIU and plasma aldosterone concentration(PAC) post-FST≥60pg/ml；or PAC>200 pg/ml，plasma renin concentration(PRC)<2.5μIU/ml，with hypokalemia
 Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge 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.
non Primary Aldosteronism
ARR<10 pg/μIU or ARR>10 pg/μIU and PAC post FST<60pg/ml
 Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. the optimal cutoff value of urine aldosterone in oral sodium test [ Time Frame: 3 days ]
    urine aldosterone


Biospecimen Retention:   Samples Without DNA
Serum, plasma and complete blood cell. 24-h urine, etc

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
hypertensive patients being suspicious of PA in a single tertiary hospital center
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193137


Locations
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China, Chongqing
Qifu Li
Chongqing, Chongqing, China, 400016
Sponsors and Collaborators
Chongqing Medical University
Investigators
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Study Chair: Qifu Li, PhD the Chongqing Primary Aldosteronism Study (CONPASS) Group
More Information
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Publications of Results:

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Responsible Party: Qifu Li, Primary Investigator, Chongqing Medical University
ClinicalTrials.gov Identifier: NCT04193137    
Other Study ID Numbers: OSL-study 2019
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qifu Li, Chongqing Medical University:
primary aldosteronism,
oral sodium loading test
captopril challenge test,
Saline infusion test
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Captopril
 Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents