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

Primary Aldosteronism Clinical Trial

Official title: Study on the Clinical Efficacy and Safety of the New Mineralocorticoid Receptor Antagonist Finerenone in the Treatment of Primary Aldosteronism: a Multicenter, Prospective, Open-label Clinical Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Primary aldosteronism(PA) is a clinical syndrome characterized by autonomous aldosterone secretion in the body caused by adrenal cortical adenoma or hyperplasia not regulated by renin, angiotensin II, and sodium status regulation. It is the most common cause of secondary hypertension, accounting for about 10% of all hypertensive patients. The latest prospective study in China showed that the prevalence of primary aldosteronism in newly diagnosed hypertensive patients was 4%, with an additional 3% of suspicious primary aldosteronism patients. Excessive activation of the mineralocorticoid receptor (MR) in the body leads to well-known increased circulating volume overload, hypertension, and hypokalemia, as well as significantly increased cardiovascular, renal, and mortality risks. Therefore, primary aldosteronism is currently considered a new public health problem and has important implications for early diagnosis and precise treatment of primary aldosteronism.

Only about 30% of patients with PA (aldosterone-producing adenoma or unilateral adrenal hyperplasia) can be cured or relieved through surgical resection, while about 65% of patients with primary aldosteronism caused by bilateral adrenal cortical hyperplasia require drug treatment. Currently, the only available drug in China is the first-generation mineralocorticoid receptor antagonist, spironolactone, which is greatly limited in its use due to its significant side effects on the gonads caused by the blockade of androgens and progesterones. Another MRA, eplerenone, which has not yet been marketed in China, is expensive and clinically inferior to spironolactone. Therefore, a large number of patients with primary aldosteronism are currently not using or using low doses of spironolactone, unable to fully counteract the high aldosterone effect, and unable to effectively control the risk of cardiovascular and renal damage. Therefore, it is necessary to explore new drugs for the treatment of primary aldosteronism.

Finerenone is a newly developed novel non-steroidal MRA, which has higher affinity and selectivity for MR binding compared to steroidal MRA (spironolactone or eplerenone). Existing clinical research results suggest that Finerenone can effectively reduce the risk of cardiovascular and renal damage in patients with chronic kidney disease and diabetes, and has good safety.

This study aims to be the first internationally to conduct clinical research on the use of the novel mineralocorticoid receptor antagonist finerenone for the treatment of primary aldosteronism. Through a multicenter, prospective, open-label study, the clinical efficacy and safety of this medication will be clearly established, providing high-level evidence of the use of finerenone in patients with primary aldosteronism. The project's results will offer a new option for the pharmacological treatment of primary aldosteronism, with the goal of better controlling patients' biochemical abnormalities, effectively reducing the risk of cardiovascular and renal damage, and improving disease prognosis. ;

Related Conditions & MeSH terms

• Hyperaldosteronism
• Mineralocorticoid Receptor Antagonist
• Primary Aldosteronism

• NCT number: NCT06381323
• Study type: Interventional
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Ping Li, Ph.D
• Phone: 86-025-83106666
• Email: li78321@yeah.net
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2024
• Completion date: April 1, 2027