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Optimizing Diagnosis Of Primary Aldosteronism (ODPA)

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: NCT02755519
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Qifu Li, Chongqing Medical University

Brief Summary:
To optimize the confirmatory tests for primary aldosteronism.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Case Detection and Confirmation, Subtype Classification of Patients With Primary Aldosteronism
Study Start Date : May 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Primary Aldosteronism
  1. Those with hypertension, and with or without hypoglycemia;
  2. Those with PAC/PRC≥42.95 pg·mL-1/µIU·mL-1
Non-Primary Aldosteronism
  1. Those with Primary Hypertension;
  2. Those with adrenal diseases except for Primary Aldosteronism



Primary Outcome Measures :
  1. Area under the receiver operating characteristic curve (AUC) for Salt loading test [ Time Frame: 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.

  2. AUC for captopril challenge test [ Time Frame: 1 week ]
    Captopril challenge test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.

  3. AUC for fludrocortisone suppression test [ Time Frame: 1 week ]
    Fludrocortisone suppression test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.


Secondary Outcome Measures :
  1. Incidence of cardiovascular diseases in Primary Aldosteronism [ Time Frame: 3 years ]
    Follow-up for the risk of cardiovascular diseases, chronic kidney disease and stroke



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Group 1: Who was diagnosed with hypertension according to JNC standard and was considered with the possibility of primary aldosteronism.

Group 2: Control Groups, one group for those without hypertension or with primary hypertension; the other group for those with adrenal diseases except for primary aldosteronism.

Criteria

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.

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): NCT02755519


Locations
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China, Chongqing
The First Affilated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400016
Sponsors and Collaborators
Chongqing Medical University
Investigators
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Principal Investigator: Qifu Li, M.D., PhD. First Affiliated Hospital of Chongqing Medical University
Publications:

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Responsible Party: Qifu Li, M.D., PhD, Chongqing Medical University
ClinicalTrials.gov Identifier: NCT02755519    
Other Study ID Numbers: ODPA 2016
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Keywords provided by Qifu Li, Chongqing Medical University:
primary aldosteronism
confirmatory test
hypertension
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases