Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381323
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-16
Brief Title:
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
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Primary aldosteronismPA 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 projects 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
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 projects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None