Ignite Creation Date:
2024-05-06 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03653845
Status:
UNKNOWN
Last Update Posted:
2018-08-31
First Post:
2018-06-07
Brief Title:
Adrenal Artery Ablation for Primary Aldosteronism
Sponsor:
Third Military Medical University
Organization:
Third Military Medical University
Study Overview
Official Title:
Adrenal Artery Ablation for Primary AldosteronismA Randomized Parallel Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Adrenal Artery AblationAAAin the Treatment of Primary Aldosteronism
Status:
UNKNOWN
Status Verified Date:
2018-08
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 causes 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
The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level which is incapable of accurate positioning diagnosis On the other hand the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism However only about 35 of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery More than 60 of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy However long-term aldosterone inhibitor treatment may also cause hyperkalemia male breast hyperplasia female hirsutism and other adverse reactions
Therefore the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level reduce the blood pressure and recover the potassium metabolism balance In order to confirm the above effects the investigators conduct an open prospective positive controlled study in patients with primary aldosteronism patients including aldosterone idiopathic aldosteronism and adrenal hyperplasia The effects on blood pressure blood electrolytes adrenal hormones metabolic indexes target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism
The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level which is incapable of accurate positioning diagnosis On the other hand the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism However only about 35 of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery More than 60 of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy However long-term aldosterone inhibitor treatment may also cause hyperkalemia male breast hyperplasia female hirsutism and other adverse reactions
Therefore the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level reduce the blood pressure and recover the potassium metabolism balance In order to confirm the above effects the investigators conduct an open prospective positive controlled study in patients with primary aldosteronism patients including aldosterone idiopathic aldosteronism and adrenal hyperplasia The effects on blood pressure blood electrolytes adrenal hormones metabolic indexes target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of 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?:
None
Is an FDA AA801 Violation?:
None