Ignite Creation Date:
2024-07-17 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462287
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-04
Brief Title:
EFFECT OF A SUBSTANCE P ANTAGONIST ON THE SECRETION OF ALDOSTERONE IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA SYNDROME AND ARTERIAL HYPERTENSION
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
PILOT STUDY OF THE EFFECT OF A SUBSTANCE P ANTAGONIST APREPITANT ON THE SECRETION OF ALDOSTERONE IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA SYNDROME AND ARTERIAL HYPERTENSION
Status:
RECRUITING
Status Verified Date:
2024-06
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:
APHOS 3
Brief Summary:
Obstructive sleep apnea syndrome OSAS is associated with hyperaldosteronism with elevated plasma aldosteronerenin ratio the physiopathological mechanism of which remains uncertain This hyperaldosteronism contributes to the development of arterial hypertension and cardiovascular complications observed in patients with OSA in particular by increasing arterial stiffness and heart rate variability The frequent association of OSA with obesity with metabolic syndrome suggests that excess weight could be responsible for stimulation of aldosterone secretion independent of the reninangiotensin system Several studies indicate in particular that the production of mineralocorticoids by the adrenals could be activated by various adipocyte secretion products such as leptin and certain fatty acids after oxidation in the liver In addition a recent study showed that basal aldosterone secretion is also controlled by substance P released within the adrenal tissue itself by nerve fibers belonging to the splanchnic contingent Thus the oral administration of aprepitant an antagonist of the substance P receptor NK1 receptor to healthy volunteers induces a reduction of approximately 30 in the overall secretion of aldosterone assessed by measuring aldosteronemia and 24-hour aldosteronuria To the extent that OSA causes sympathetic hypertonia the hypothesis is that the associated hyperaldosteronism could result from activation of the nervous control of aldosterone secretion involving substance P and the NK1 receptor If this is indeed the case the administration of aprepitant to patients with OSA should result in a significant reduction in aldosteronemia
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