Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

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

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

Study Overview

• Status: Recruiting
• Conditions: Primary Aldosteronism
• Intervention / Treatment: Drug: finerenone

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Qifu Q Li, PhD; Phone Number: +86 023-89011552; Email: liqifu@yeah.net

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • Recruiting
      • The First Affilated Hospital of Chongqing Medical University
      • Contact: Qifu Q Li, PhD; Phone Number: +862389011552; Email: liqifu@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Chongqing Medical University
• Investigators: Study Chair: Qifu Q Li, PhD, the Chongqing Primary Aldosteronism Study (CONPASS) Group

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): December 8, 2023
• Study Completion (Estimated): December 8, 2023

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: spironolactone; finerenone
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism
• Other Study ID Numbers: Finerenone study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes