Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

NCT ID: NCT05924620

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-21
• Study Completion Date: 2024-03-12

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.

Conditions

Primary Aldosteronism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with PA using finerenone

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

Group Type: EXPERIMENTAL

finerenone

Intervention Type: DRUG

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

Patients with PA using spironolactone

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

finerenone

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

Intervention Type: DRUG

Other Intervention Names

Kerendia

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qifu Li

Professor.Qifu Li

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qifu Q Li, PhD

Role: STUDY_CHAIR

the Chongqing Primary Aldosteronism Study (CONPASS) Group

Locations

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

Finerenone study

Identifier Type: -

Identifier Source: org_study_id