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Trial record 2 of 3 for:    "Conn's Syndrome" | "Angiotensin-Converting Enzyme Inhibitors"

Diagnostic Accuracy of Seated Saline Suppression Test for Primary Aldosteronism

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ClinicalTrials.gov Identifier: NCT03500120
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Qifu Li, Chongqing Medical University

Brief Summary:
The present study was undertaken prospectively to compare the diagnostic significance of the seated saline suppression testing (SSST) with the captopril challenge testing (CCT) in hypertensive patients with suspected primary aldosteronism (PA) using the fludrocortisone suppression testing (FST) as the reference standard, and to investigate the optimal cutoff of SSST for differentiating PA from other forms of hypertension.

Condition or disease Intervention/treatment
Primary Aldosteronism Diagnostic Test: Seated saline infusion test

Detailed Description:
The diagnosis of primary aldosteronism (PA) typically requires at least one confirmatory test. Four tests are commonly recommended by the Endocrine Society guideline, namely, oral sodium loading, saline infusion, fludrocortisone administration with oral sodium loading, and captopril challenge testing (CCT). Of these, fludrocortisone suppression testing (FST) has been considered the most reliable, but is cumbersome, difficult to perform, and relatively expensive, requiring hospital admission for several days. Alternative approaches to FST have included saline suppression testing (SST), Which requiring patients staying in the recumbent position for at least 1 h before and during the infusion of 2 L of 0.9% saline IV over 4 h. This approach also has the disadvantages of brings much inconvenience to the patient (such as urination or defecation, etc.). Ashraf H. et al. have reported that seated SST (SSST) is more sensitive than recumbent SST (RSST), especially for posture-responsive PA (95.8% versus 33.3%), however, in this small scale study, only 31 patients was PA and only three patients was tested negative for PA by FST. Specificity of each form of SST was unable to estimate and meaningful receiver operating characteristic (ROC) curve analyses could not be performed. Furthermore, it is lack of study in Chinese people. In addition, the investigators have previously found the CCT was as accurate as the FST and plasma aldosterone concentration (PAC) post-CCT is the best approach to interpret the results of the CCT. The present study was undertaken prospectively to compare the diagnostic significance of the SSST with the CCT in hypertensive patients with suspected PA using the FST as the reference standard, and to investigate the optimal cutoff of SSST for differentiating PA from other forms of hypertension.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Case Detection and Confirmation, Subtype Classification of Patients With Primary Aldosteronism
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Captopril

Group/Cohort Intervention/treatment
Primary Aldosteronism

1. Aldosterone/renin concentration ratio(ARR)≥1.0 (ng/dl)/(mIU/l) or ARR<1.0 (ng/dl)/(mIU/l) but PA was strongly suspected.

and 2. PAC post-FST≥6 ng/dl

Diagnostic Test: Seated saline infusion test

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

Fludrocortisone suppression test:Patients received 0.1 mg oral fludrocortisone every 6 h for 4 days, together with slow-release potassium chloride and sodium chloride supplements.

Captopril challenge test:Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 1 h. Blood samples were drawn at time zero and 2 h after the challenge.

Other Names:
  • Captopril challenge test
  • Fludrocortisone suppression test

non Primary Aldosteronism
1. ARR<1.0 (ng/dl)/(mIU/l) and 2. PAC post-FST<6 ng/dl
Diagnostic Test: Seated saline infusion test

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

Fludrocortisone suppression test:Patients received 0.1 mg oral fludrocortisone every 6 h for 4 days, together with slow-release potassium chloride and sodium chloride supplements.

Captopril challenge test:Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 1 h. Blood samples were drawn at time zero and 2 h after the challenge.

Other Names:
  • Captopril challenge test
  • Fludrocortisone suppression test




Primary Outcome Measures :
  1. Diagnostic Accuracy of Seated Saline Suppression Test [ Time Frame: 2 weeks ]
    compare the diagnostic significance of the SSST with the CCT in hypertensive patients with suspected PA using the FST as the reference standard


Secondary Outcome Measures :
  1. The cutoff of SSST for diagnosis of PA [ Time Frame: 2 weeks ]
    investigate the optimal cutoff of SSST for differentiating PA from other forms of hypertension.


Biospecimen Retention:   Samples With DNA
Serum, plasma and complete blood cell. Application: 1. diagnosis of PA and primary hypertension; 2.differential diagnosis of PA;


Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
Hospital or clinic patients with hypertension in a single tertiary hospital center.
Criteria

Inclusion Criteria:

  1. patients with Joint National Commission stage 2 (>160-179/100-109mm Hg), stage 3 (>180/110 mmHg), or drug-resistant hypertension;
  2. hypertension and spontaneous or diuretic-induced hypokalemia;
  3. hypertension with adrenal incidentaloma;
  4. hypertension and a family history of early-onset hypertension;
  5. cerebrovascular accident at a young age (<40 years);
  6. all hypertensive first-degree relatives of patients with PA.

Exclusion Criteria:

  1. heart failure;
  2. chronic kidney disease with an estimated Glomerular Filtration Rate <30 ml/min/1.73 m2;
  3. liver cirrhosis;
  4. terminal malignant tumor;
  5. current use of steroids or oral contraceptives;
  6. pregnancy or lactation.

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): NCT03500120


Locations
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China, Chongqing
The First Affilated Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China, 400016
Contact: Qifu Li, M.D., PhD.    023-89011552    liqifu@yeah.net   
Contact: Ying Song, M.D.    023-89011552    shuiyunying@126.com   
Sponsors and Collaborators
Chongqing Medical University
Investigators
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Study Chair: Qifu Li, PHD the Chongqing Primary Aldosteronism Study (CONPASS) Group

Additional Information:

Publications of Results:
Other Publications:
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Responsible Party: Qifu Li, M.D., PhD, Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03500120     History of Changes
Other Study ID Numbers: DASSSTPA 2017
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
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:
Saline suppression testing, Seated, Recumbent

Additional relevant MeSH terms:
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Angiotensin-Converting Enzyme Inhibitors
Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Fludrocortisone
Captopril
Anti-Inflammatory Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents