Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814770
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-18
First Post:
2023-03-13
Brief Title:
Comparing the Efficacy and Safety of Finerenone and Spironolactone 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:
Compare the Efficacy and Safety of Finerenone a New Type of Mineralocorticoid Receptor Antagonist and Spironolactone in the Treatment of Primary Aldosteronism a Single-Center Prospective Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
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:
Primary aldosteronism PA is thought to be the most common secondary endocrine form of hypertension Compared with patients with essential hypertension with similar blood pressure patients with PA have significantly higher atrial fibrillation myocardial infarction heart failure stroke deterioration of renal function and all-cause mortality Therefore early and systematic implementation of effective surgical or medical treatment is essential to prevent or reverse the excess vascular events and mortality of these patients The patients with bilateral PA were mainly treated with mineralocorticoid receptor antagonists MRAs The MRA spironolactone is effective at lowering BP and reversing the harmful metabolic consequences but its use is limited by adverse effects such as gynaecomastia mastodynia menstrual abnormalities and impotence due to its agonist activity at the progesterone receptor and antagonist activity at the androgen receptor Finerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects In this study we will compare the efficacy safety and tolerability of finerenone versus spironolactone in patients with hypertension associated with primary aldosteronism
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None