Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

Primary Aldosteronism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05924620
• Other study ID #: Finerenone study
• Status: Recruiting
• Phase: Phase 4
• Start date: June 20, 2023
• Est. completion date: December 8, 2023

Study information

• Verified date: July 2023
• Source: Chongqing Medical University
• Contact: Qifu Q Li, PhD
• Phone: +86 023-89011552
• Email: liqifu[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the efficacy and safety of finerenone in patients with primary aldosteronism

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 8, 2023
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Intervention

Drug:
• finerenone
Patients with PA divided into Intervention group need to take finerenone for 60 days (20mg qd).

Locations

Country	Name	City	State
China	The First Affilated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare the serum potassium elevation in the overall cohort between two groups.	Measured by blood electrolytes	At baseline and 2 month of follow-up
Secondary	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