Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

Chongqing Medical University

Status and phase: Completed; Phase 4

Conditions: Primary Aldosteronism

Treatments: Drug: finerenone

Study type: Interventional

Funder types: Other

Identifiers

NCT05924620

Finerenone study

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Patients with PA using finerenone

Experimental group

Description:

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

Treatment:

Drug: finerenone

Patients with PA using spironolactone

No Intervention group

Description:

Patients with PA divided into this group need to take spironolactone for 60 days (20mg qd)