Study URL

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000021690

Aim

First goal is to establish high-quality and standardized clinical practice guideline of primary aldosteronism (especially that of severe type) by producing evidence as answers for major clinical questions related to confirmatory tests, subtype diagnosis, and treatment. Second goal is to develop new diagnostic biomarkers for the diagnosis of severe type PA from the genome/epigenome analysis.

Subjects

PA patients diagnosed and subjected to AVS between Jan. 2006 and Dec. 2016 at Kyoto Medical Center or collaborating institutions. Patients of WAVES-J are included.

Inclusion criteria

From 20 years to 90 years of age

Exclusion criteria

If the attending physician decided inappropriate for the study

Methods

Design

Observational study

Target No. of cases

About 2,500

Endpoints

Primary outcome measure

1. 1)　Basic information（age, gender, duration of hypertension, family history, past history, major complications, medication, symptom, height, weight, blood pressure, pulse rate etc.）, blood chemistry, confirmatory tests, CT findings, etc.
2. 2)　AVS: methods, indices, cut-off, etc.
3. 3)　comparison of effects between medication and surgery
4. 4)　postoperative outcome（blood pressure, electrolytes, target organ damages, etc.）

Secondary outcome measure

1. 1)　Surgical findings
2. 2)　Target organ damage: Kidney (sCr,BUN, eGFR)、Heart（ECG；Chest XP：CTR）
3. 3)　Clinical course：basic information and lab data of 6 months、1 year、３ years、5years

Study period

• Study period：June, 2015～Dec, 2021
• Entry period：June, 2015～Dec, 2016
• Follow up period：June, 2015～Dec, 2021

Schedule of follow up

6months, 1 year, 3 years, and 5 years after adrenal surgery or the diagnosis of PA