Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

Study Overview
=================
Brief Summary
-----------------
To study the efficacy and safety of finerenone in patients with primary aldosteronism

Detailed Description
-----------------
This is a prospective and randomized study involving patients with primary aldosteronism(PA). All paticipants will be randomized into finerenone group(Intervention group) and spironolactone group(Control group) and to compare the antihypertensive effect in patients with PA. If the self-measured blood pressure of patients at home continues to be greater than 140/90 mmHg at 2-4 weeks, spironolactone or finerenone should be increased to 40mg qd, and electrolytes should be reviewed at 2 weeks after dosed.

Official Title
-----------------
Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism: a Randomized, Controlled Trial

Conditions
-----------------
Primary Aldosteronism

Intervention / Treatment
-----------------
* Drug: finerenone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who meet the following criterion can be included in this study. Patients know the whole process of the trial and voluntarily accepted randomization, intervention and follow-up. Patients voluntarily participated in the study and signed an informed consent, willing to complete all follow-up visits as required. Aged between 18-70, male or female, with legal capacity. eGFR≥60(ml/min/1.73 m2) Patients with PA and substandard blood pressure (≥140/90mmHg) who didn't take any antihypertensive drugs or who had been using antihypertensive drugs other than MRA steadily for 2 weeks or more Exclusion Criteria: Patients with one of the following conditions will be excluded in this study: To assess patients with poor compliance who had difficulty fully participating in the study, or who refused to sign written informed consent for the study Patients with heart failure (New York Heart Association (NYHA) class III or IV), liver transaminase levels were more than 2 times higher than the upper limit of normal, estimated glomerulus filtration rate<30ml/min/m2 Patients with serum potassium > 5.0mmol/L without potassium supplementation Patients with stroke or acute coronary syndrome within 3 months Pregnant or lactating women Patients currently receiving sex hormone or glucocorticoid therapy Patients with a history of uncontrolled malignant tumor Patients who took MRA within 2 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with PA using finerenone<br>Patients with PA divided into this group need to take finerenone for 60 days (20mg qd) | Drug: finerenone<br>* Patients with PA divided into Intervention group need to take finerenone for 60 days (20mg qd).<br>* Other names: Kerendia;|
| No Intervention: Patients with PA using spironolactone<br>Patients with PA divided into this group need to take spironolactone for 60 days (20mg qd) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the change of daytime mean systolic blood pressure in the overall cohort between two groups. | Measured by ambulatory blood pressure monitoring | At baseline and 2 month of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the serum potassium elevation in the overall cohort between two groups. | Measured by blood electrolytes | At baseline and 2 month of follow-up | 
| Compare the change of daytime mean diastolic blood pressure in the overall cohort between two groups. | Measured by ambulatory blood pressure monitoring | At baseline and 2 month of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
finerenone, spironolactone