The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ID
NCT06381323
Phase
PHASE4
Status
Completed

Conditions

  • Finerenone
  • Mineralocorticoid Receptor Antagonist
  • Primary Aldosteronism

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Finerenone — DRUG
    All eligible subjects enter a 2-week enrollment phase and only take stable doses of controlled-release nifedipine. After completing baseline examinations, subjects with SBP \<180 and ≥140 mmHg and DBP \<120 and ≥90 mmHg enter the follow-up phase of the treatment period. Eligible subjects receive a starting dose of 20 mg qd of Finerenone. If the blood pressure is still ≥140/90 mmHg at week 4, serum potassium is \<5.0 mmol/L, and eGFR has decreased \<30% compared to baseline, the Finerenone dose is adjusted to 40 mg qd.

Study Details

The purpose of our research is to clarify the therapeutic efficacy and safety of Finerenone in patients with Primary Aldosteronism and explore the effective clinical predictive indicators of Finerenone in the treatment of Primary Aldosteronism.

Key Dates

Start date
Mar 1, 2024
Status verified
Mar 2024
Primary completion
Jun 1, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
55 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone
    Recruitment of diagnosed patients with PA from multiple centers, confirmation of subject eligibility according to inclusion criteria and exclusion criteria, and signing of informed consent forms. All eligible subjects enter a 2-week enrollment phase and only take stable doses of controlled-release nifedipine. After completing baseline examinations, subjects with SBP \<180 and ≥140 mmHg and DBP \<120 and ≥90 mmHg enter the follow-up phase of the treatment period. Eligible subjects receive a starting dose of 20 mg qd of Finerenone. If the blood pressure is still ≥140/90 mmHg at week 4, serum potassium is \<5.0 mmol/L, and eGFR has decreased \<30% compared to baseline, the Finerenone dose is adjusted to 40 mg qd.

Primary Outcome Measure

24h systolic BP drop value [ Time Frame: 12 weeks ]

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