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Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

Primary Purpose

Primary Aldosteronism

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
finerenone
Sponsored by
Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Aldosteronism focused on measuring finerenone, spironolactone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who meet the following criterion can be included in this study. Patients know the whole process of the trial and voluntarily accepted randomization, intervention and follow-up. Patients voluntarily participated in the study and signed an informed consent, willing to complete all follow-up visits as required. Aged between 18-70, male or female, with legal capacity. eGFR≥60(ml/min/1.73 m2) 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: 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 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 Patients with serum potassium > 5.0mmol/L without potassium supplementation Patients with stroke or acute coronary syndrome within 3 months Pregnant or lactating women Patients currently receiving sex hormone or glucocorticoid therapy Patients with a history of uncontrolled malignant tumor Patients who took MRA within 2 weeks

Sites / Locations

  • The First Affilated Hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patients with PA using finerenone

Patients with PA using spironolactone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Compare the change of daytime mean systolic blood pressure in the overall cohort between two groups.
Measured by ambulatory blood pressure monitoring

Secondary Outcome Measures

Compare the serum potassium elevation in the overall cohort between two groups.
Measured by blood electrolytes
Compare the change of daytime mean diastolic blood pressure in the overall cohort between two groups.
Measured by ambulatory blood pressure monitoring

Full Information

First Posted
June 21, 2023
Last Updated
July 3, 2023
Sponsor
Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05924620
Brief Title
Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism
Official Title
Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
December 8, 2023 (Anticipated)
Study Completion Date
December 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing Medical University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism
Keywords
finerenone, spironolactone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with PA using finerenone
Arm Type
Experimental
Arm Description
Patients with PA divided into this group need to take finerenone for 60 days (20mg qd)
Arm Title
Patients with PA using spironolactone
Arm Type
No Intervention
Arm Description
Patients with PA divided into this group need to take spironolactone for 60 days (20mg qd)
Intervention Type
Drug
Intervention Name(s)
finerenone
Other Intervention Name(s)
Kerendia
Intervention Description
Patients with PA divided into Intervention group need to take finerenone for 60 days (20mg qd).
Primary Outcome Measure Information:
Title
Compare the change of daytime mean systolic blood pressure in the overall cohort between two groups.
Description
Measured by ambulatory blood pressure monitoring
Time Frame
At baseline and 2 month of follow-up
Secondary Outcome Measure Information:
Title
Compare the serum potassium elevation in the overall cohort between two groups.
Description
Measured by blood electrolytes
Time Frame
At baseline and 2 month of follow-up
Title
Compare the change of daytime mean diastolic blood pressure in the overall cohort between two groups.
Description
Measured by ambulatory blood pressure monitoring
Time Frame
At baseline and 2 month of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who meet the following criterion can be included in this study. Patients know the whole process of the trial and voluntarily accepted randomization, intervention and follow-up. Patients voluntarily participated in the study and signed an informed consent, willing to complete all follow-up visits as required. Aged between 18-70, male or female, with legal capacity. eGFR≥60(ml/min/1.73 m2) 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: 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 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 Patients with serum potassium > 5.0mmol/L without potassium supplementation Patients with stroke or acute coronary syndrome within 3 months Pregnant or lactating women Patients currently receiving sex hormone or glucocorticoid therapy Patients with a history of uncontrolled malignant tumor Patients who took MRA within 2 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qifu Q Li, PhD
Phone
+86 023-89011552
Email
liqifu@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qifu Q Li, PhD
Organizational Affiliation
the Chongqing Primary Aldosteronism Study (CONPASS) Group
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affilated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qifu Q Li, PhD
Phone
+862389011552
Email
liqifu@yeah.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

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