Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04409431
Status:
RECRUITING
Last Update Posted:
2020-06-01
First Post:
2020-02-10
Brief Title:
Effects of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism
Sponsor:
Third Military Medical University
Organization:
Third Military Medical University
Study Overview
Official Title:
An Open-label Cohort Study on Effects and Long-term Prognosis of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
RECRUITING
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 one of the most common cause of endocrine and resistant hypertension Current studies have shown that the activation of the renin-angiotensin-aldosterone system RAAS and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure and its organ damages
Current guidelines suggest that surgery and aldosterone receptor inhibitors are the only treatment for primary aldosteronism However only about 35 of aldosterone tumors and a small number of unilateral adrenal hyperplasia can be treated surgically More than 60 of primary aldosteronism and bilateral adrenal hyperplasia need long-term oral aldosterone receptor inhibitors At present spironolactone is the most commonly used aldosterone receptor inhibitor Long term use of spironolactone may cause hyperkalemia hyperplasia of male mammary gland hairiness of female and other adverse reactions Therefore the researchers suggest that partial removal of adrenals can reduce aldosterone level lower blood pressure and restore potassium metabolism balance
In patients with primary hyperaldosteronism the level of aldosterone increases which can cause vascular endothelial dysfunction myocardial injury and ventricular fibrosis The study shows that long-term oral administration of spironolactone can reverse the above cardiovascular damage and correct heart failure Adrenal artery ablation can reduce aldosterone level but the long-term effect on cardiovascular system is unknown In order to confirm the effect of adrenal artery ablation on blood pressure and cardiovascular system the researchers conducted an open cohort study on patients with primary aldosteronism including aldosterone idiopathic aldosteronism and adrenal hyperplasia To observe the effect of adrenal artery ablation and spironolactone on blood pressure blood electrolyte metabolic index cardiovascular events and cardiovascular death risk in patients with primary aldosteronism and to explore its efficacy and safety
Current guidelines suggest that surgery and aldosterone receptor inhibitors are the only treatment for primary aldosteronism However only about 35 of aldosterone tumors and a small number of unilateral adrenal hyperplasia can be treated surgically More than 60 of primary aldosteronism and bilateral adrenal hyperplasia need long-term oral aldosterone receptor inhibitors At present spironolactone is the most commonly used aldosterone receptor inhibitor Long term use of spironolactone may cause hyperkalemia hyperplasia of male mammary gland hairiness of female and other adverse reactions Therefore the researchers suggest that partial removal of adrenals can reduce aldosterone level lower blood pressure and restore potassium metabolism balance
In patients with primary hyperaldosteronism the level of aldosterone increases which can cause vascular endothelial dysfunction myocardial injury and ventricular fibrosis The study shows that long-term oral administration of spironolactone can reverse the above cardiovascular damage and correct heart failure Adrenal artery ablation can reduce aldosterone level but the long-term effect on cardiovascular system is unknown In order to confirm the effect of adrenal artery ablation on blood pressure and cardiovascular system the researchers conducted an open cohort study on patients with primary aldosteronism including aldosterone idiopathic aldosteronism and adrenal hyperplasia To observe the effect of adrenal artery ablation and spironolactone on blood pressure blood electrolyte metabolic index cardiovascular events and cardiovascular death risk in patients with primary aldosteronism and to explore its efficacy and safety
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?:
None
Is an FDA AA801 Violation?:
None