Optimizing Diagnosis Of Primary Aldosteronism

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02755519

Acronym

ODPA

Enrollment

300

Registered

2016-04-29

Start date

2014-05-31

Completion date

2016-10-31

Last updated

2016-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Aldosteronism

Keywords

primary aldosteronism, confirmatory test, hypertension

Brief summary

To optimize the confirmatory tests for 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Area under the receiver operating characteristic curve (AUC) for Salt loading test	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.
AUC for captopril challenge test	1 week	Captopril challenge test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.
AUC for fludrocortisone suppression test	1 week	Fludrocortisone suppression test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.

Secondary

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

Countries

China

Outcome results