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Completed

NCT Number: NCT02755519

Optimizing Diagnosis Of Primary Aldosteronism

To optimize the confirmatory tests for primary aldosteronism.

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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Cardiovascular Diseases Endocrine System Diseases Hyperaldosteronism Hypertension Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

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

Acronym: ODPA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 29, 2016
Registry last updated
Nov 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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