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

NCT06381323 | Completed Phase 4

• 1 other identifier: PA2024
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Aldosteronism; Finerenone; Mineralocorticoid Receptor Antagonist

Keywords

Primary Aldosteronism; Finerenone; Mineralocorticoid Receptor Antagonist; Hypertension; 24-hour ambulatory blood pressure monitoring; Daytime SBP

Outcome Measures

Primary Outcomes (1)

• 24h systolic BP drop value

  The average daytime systolic blood pressure drop from baseline levels after treatment with Finerenone at 12 weeks.

  12 weeks

Secondary Outcomes (7)

• The change of diastolic BP from the baseline level after Finerenone treatment

  Baseline,4 weeks,8 weeks,12 weeks,16 weeks

• Hypertension remission rate

  Baseline,4 weeks,8 weeks,12 weeks,16 weeks

• Change of serum potassium level

  Baseline,4 weeks,8 weeks,12 weeks,16 weeks

• Change of plasma renin activity

  Baseline,4 week,8 weeks,12 weeks,16 weeks

• Change of ARR

  Baseline,4 weeks,8 weeks,12 weeks,16 weeks

Other Outcomes (1)

• Incidence of Treatment-Adverse Events as assessed by gynaecomastia, mastodynia, menstrual abnormalities, impotence, hyperkalemia and other adverse events.

  Baseline,4 weeks,8 weeks,12 weeks,16 weeks

Study Arms (1)

Finerenone

EXPERIMENTAL

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.

Drug: Finerenone

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.

Also known as: Nifedipine

Finerenone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:18-75 years old.
• History of hypertension, with a sitting SBP ≥140 and \<180 mmHg, and a sitting DBP ≥90 and \<120 mmHg during the last two evaluations within the observation period.
• Patients with PA who are eligible for drug treatment.
• Diagnostic criteria for primary aldosteronism: (1) Hypertension or use of antihypertensive medications, with or without hypokalemia; (2) Screening test: Baseline plasma aldosterone to renin ratio (ARR) \>30 (ng/dl)/(ng/ml/h) or ARR \>2.4 (ng/dl)/(mU/L), with plasma aldosterone \>15 ng/dl and plasma renin activity \<1.0 ng/ml/h; (3) At least one confirmed test is positive: ① After a captopril test, plasma aldosterone decreases by \<30% or plasma aldosterone is ≥11 ng/dl, with suppressed renin activity; ② Sitting saline infusion test results in a plasma aldosterone ≥10 ng/dl.
• eGFR ≥60 ml/ (min\*1.73m2).
• Signed informed consent form.

You may not qualify if:

• Other secondary hypertension (such as renal vascular hypertension, Cushing's syndrome, subclinical Cushing's syndrome, and pheochromocytoma) or hypertensive crisis.
• Orthostatic hypotension.
• Heart failure, acute myocardial infarction, stroke, transient ischemic attack, or other acute cardiovascular events within the past 6 months.
• History of adrenal surgery within the past 6 months.
• History of carotid artery surgery within the past 6 months.
• History of arterial vascular reconstruction surgery within the past 6 months.
• Hospitalization within the past year due to severe hyperkalemia, with serum potassium levels \<2.5 or ≥5.0 mmol/L.
• Abnormal liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5× upper limit of normal (ULN), total bilirubin (TBIL) \> 1.5× ULN.
• Use of spironolactone, hydralazine, or minoxidil within 30 days prior to enrollment.
• Concurrent use of potent CYP3A4 inhibitors or inducers for treatment.
• Known or suspected tumors; other autoimmune diseases, uncontrolled infectious diseases, severe respiratory, blood, and neurological diseases.
• Pregnancy or planning pregnancy within 3 months before or after treatment, and breastfeeding women.
• Mental illness, alcohol or drug abuse, inability to cooperate with treatment.
• Patients with pacemakers.
• Participation in other clinical trials.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Related Publications (1)

• Li P, Yang F, Lou Y, Zhang Z, Du Y, Zhang J, Ren Y, Tong A, Xie Z, Shi B, Liu J, Liu L, Zhu D. Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism: A Multicenter Prospective Study. Hypertension. 2026 Jan 22. doi: 10.1161/HYPERTENSIONAHA.125.26048. Online ahead of print.

  PMID: 41568520 DERIVED

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Interventions

finerenone; Nifedipine

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ping Li

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 24, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 10, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

CN (1)