Optimizing Diagnosis Of Primary Aldosteronism (ODPA)

November 10, 2016 updated by: Qifu Li, Chongqing Medical University

Case Detection and Confirmation, Subtype Classification of Patients With Primary Aldosteronism

To optimize the confirmatory tests for primary aldosteronism.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affilated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week
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.
1 week
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cardiovascular diseases in Primary Aldosteronism
Time Frame: 3 years
Follow-up for the risk of cardiovascular diseases, chronic kidney disease and stroke
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Investigators

  • Principal Investigator: Qifu Li, M.D., PhD., First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 8, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Estimate)

November 11, 2016

Last Update Submitted That Met QC Criteria

November 10, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ODPA 2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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