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Optimizing Diagnosis Of Primary Aldosteronism

NCT ID: NCT02755519

Last Updated: 2016-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-10-31

Brief Summary

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To optimize the confirmatory tests for primary aldosteronism.

Detailed Description

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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.

Conditions

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Primary Aldosteronism

Keywords

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primary aldosteronism confirmatory test hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary Aldosteronism

1. Those with hypertension, and with or without hypoglycemia;
2. Those with PAC/PRC≥42.95 pg·mL-1/µIU·mL-1

No interventions assigned to this group

Non-Primary Aldosteronism

1. Those with Primary Hypertension;
2. Those with adrenal diseases except for Primary Aldosteronism

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qifu Li

M.D., PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qifu Li, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Chongqing Medical University

Locations

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The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

References

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Rossi GP, Belfiore A, Bernini G, Desideri G, Fabris B, Ferri C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Montemurro D, Palumbo G, Rizzoni D, Rossi E, Semplicini A, Agabiti-Rosei E, Pessina AC, Mantero F; PAPY Study Investigators. Prospective evaluation of the saline infusion test for excluding primary aldosteronism due to aldosterone-producing adenoma. J Hypertens. 2007 Jul;25(7):1433-42. doi: 10.1097/HJH.0b013e328126856e.

Reference Type BACKGROUND
PMID: 17563566 (View on PubMed)

Ahmed AH, Cowley D, Wolley M, Gordon RD, Xu S, Taylor PJ, Stowasser M. Seated saline suppression testing for the diagnosis of primary aldosteronism: a preliminary study. J Clin Endocrinol Metab. 2014 Aug;99(8):2745-53. doi: 10.1210/jc.2014-1153. Epub 2014 Apr 24.

Reference Type BACKGROUND
PMID: 24762111 (View on PubMed)

Li Y, Liu Y, Li J, Wang X, Yu Y. Sodium Infusion Test for Diagnosis of Primary Aldosteronism in Chinese Population. J Clin Endocrinol Metab. 2016 Jan;101(1):89-95. doi: 10.1210/jc.2015-2840. Epub 2015 Nov 13.

Reference Type BACKGROUND
PMID: 26565948 (View on PubMed)

Nanba K, Tamanaha T, Nakao K, Kawashima ST, Usui T, Tagami T, Okuno H, Shimatsu A, Suzuki T, Naruse M. Confirmatory testing in primary aldosteronism. J Clin Endocrinol Metab. 2012 May;97(5):1688-94. doi: 10.1210/jc.2011-2504. Epub 2012 Mar 14.

Reference Type BACKGROUND
PMID: 22419718 (View on PubMed)

Schirpenbach C, Seiler L, Maser-Gluth C, Rudiger F, Nickel C, Beuschlein F, Reincke M. Confirmatory testing in normokalaemic primary aldosteronism: the value of the saline infusion test and urinary aldosterone metabolites. Eur J Endocrinol. 2006 Jun;154(6):865-73. doi: 10.1530/eje.1.02164.

Reference Type BACKGROUND
PMID: 16728547 (View on PubMed)

Agharazii M, Douville P, Grose JH, Lebel M. Captopril suppression versus salt loading in confirming primary aldosteronism. Hypertension. 2001 Jun;37(6):1440-3. doi: 10.1161/01.hyp.37.6.1440.

Reference Type BACKGROUND
PMID: 11408392 (View on PubMed)

Other Identifiers

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ODPA 2016

Identifier Type: -

Identifier Source: org_study_id