Study URL

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000010208

Aim

The aim of the study is to clarify the adherence of clinical guideline and to establish standard medication of primary aldosteronism

Subjects

Inclusion criteria:

  1.Hypertensive patients in the outpatient clinics and hospitals, who full-fill the following 1) or

     2) criteria:

   1)  treated hypertensive patients 2) untreated hypertensive patients with systolic blood

        pressure higher than 140mmHg or diastolic blood pressure higher than 90mmHg

        according to the guideline of the Japan Society of Hypertension

  2. Age: more than 20 years of age and less than 90 years of age

  3. Gender: male and female

Exclusion criteria

 1. pregnant patients

 2. patients taking aldosterone antagonist within the last one month

 3. patients with the following diseases:

   1) secondary hypertension (renal hypertension, renovascular hypertension,

       primary aldosteronism, Cushing syndrome, pheochromocytoma, etc.)

   2) patients whom the attending doctors decides not suitable for the entry because of

       the unstable stage of the following complications: coronary diseases, arrhythmia,

       severe valvular diseases, cerebrovascular diseases, acute and chronic renal failure

       (serum Cr higher than 3mg/dl), acute and chronic liver diseases

 4. Patients whom the attending doctor decides not suitable for the entry of the study

Methods

Study design: Observational, multi-center study and randomized controlled trial

Target sample size: 2,700 cases

End point

Primary outcome

1. Adherence of clinical guideline for PA

2. Establishment of standard medication in PA and aldosterone-rerated hypertension.

Secondary outcome

1. Implementation rate of each diagnostic procedure

2. Successful rate of the localization

3. Comparison of the effects of medical treatments and surgical treatment

Research period

Case recruitment: December, 2012-August, 2015

Follow-up: April, 2012-March, 2018