Clincosm LogoSign in Get a demo

Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

Sponsor
Chongqing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05924620
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
5.6
Anticipated Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism: a Randomized, Controlled Trial
Actual Study Start Date :
Jun 20, 2023
Anticipated Primary Completion Date :
Dec 8, 2023
Anticipated Study Completion Date :
Dec 8, 2023

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    1. Compare the change of daytime mean systolic blood pressure in the overall cohort between two groups. [At baseline and 2 month of follow-up]

      Measured by ambulatory blood pressure monitoring

    Secondary Outcome Measures

    1. Compare the serum potassium elevation in the overall cohort between two groups. [At baseline and 2 month of follow-up]

      Measured by blood electrolytes

    2. Compare the change of daytime mean diastolic blood pressure in the overall cohort between two groups. [At baseline and 2 month of follow-up]

      Measured by ambulatory blood pressure monitoring

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affilated Hospital of Chongqing Medical University Chongqing Chongqing China 400016

    Sponsors and Collaborators

    • Chongqing Medical University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qifu Li, Professor.Qifu Li, Chongqing Medical University
    ClinicalTrials.gov Identifier:
    NCT05924620
    Other Study ID Numbers:
    • Finerenone study
    First Posted:
    Jun 29, 2023
    Last Update Posted:
    Jul 6, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Qifu Li, Professor.Qifu Li, Chongqing Medical University
    finerenone
    spironolactone
    Additional relevant MeSH terms:
    Hyperaldosteronism

    Study Results

    No Results Posted as of Jul 6, 2023