Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

Last updated: June 15, 2024
Sponsor: Chongqing Medical University
Overall Status: Completed

Phase

4

Condition

N/A

Treatment

finerenone

Clinical Study ID

NCT05924620
Finerenone study
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 anyantihypertensive drugs or who had been using antihypertensive drugs other than MRAsteadily for 2 weeks or more

Exclusion

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 inthe 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 ofnormal, 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 Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: finerenone
Phase: 4
Study Start date:
June 21, 2023
Estimated Completion Date:
March 12, 2024

Study 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.

Connect with a study center

  • The First Affilated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400016
    China

    Site Not Available

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