Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

Phase 4

Completed

• Conditions: Primary Aldosteronism
• Interventions: Drug: finerenone

• Registration Number: NCT05924620
• Lead Sponsor: Chongqing Medical University

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.

Study Timeline

• Study Start: 2023-06-21
• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-06-21
• Study First Posted: 2023-06-29
• Status Verified: 2023-07
• Primary Completion: 2024-03-12
• Study Completion: 2024-03-12
• Last Update Submitted: 2024-06-15
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients who meet the following criterion can be included in this study.

1. Patients know the whole process of the trial and voluntarily accepted randomization, intervention and follow-up.
2. Patients voluntarily participated in the study and signed an informed consent, willing to complete all follow-up visits as required.
3. Aged between 18-70, male or female, with legal capacity.
4. eGFR≥60(ml/min/1.73 m2)
5. 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:

1. 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
2. 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
3. Patients with serum potassium > 5.0mmol/L without potassium supplementation
4. Patients with stroke or acute coronary syndrome within 3 months
5. Pregnant or lactating women
6. Patients currently receiving sex hormone or glucocorticoid therapy
7. Patients with a history of uncontrolled malignant tumor
8. Patients who took MRA within 2 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with PA using finerenone	finerenone	Patients with PA divided into this group need to take finerenone for 60 days (20mg qd)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affilated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China