Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism

Not Applicable

Completed

• Conditions: Adenoma
• Interventions: Device: complier device

• Registration Number: NCT01190501
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Our main objective is to assess whether aortic stiffness is a predictor of blood pressure response after surgery in patients with an aldosterone producing adenoma or a unilateral adrenal hyperplasia.

Detailed Description

Secondary objectives are to investigate whether aortic stiffness predicts cardiovascular , operative and postoperative morbid-mortality at 1 year, to evaluate the benefit of adrenalectomy in patients with primary aldosteronism due to unilateral adrenal hyperplasia and in patients with aldosterone producing adenoma associated with controlateral adrenal morphological abnormalities, and to participate to a national DNA repository of patients with primary aldosteronism.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-27
• Primary Completion: 2014-02
• Study Completion: 2015-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• patients with a surgically correctable primary aldosteronism due to an aldosterone producing adenoma or an unilateral adrenal hyperplasia
• primary aldosteronism demonstrated by hormonal essays
• hight resolution adrenal CT scan
• operative decision based on the usual criteria of the different referent centers

Exclusion Criteria

• patient's refusal to undergo the surgery or to participate in the study
• the patients with PA due to bilateral adrenal hyperplasia or with idiopathic primary aldosteronism, and patients with a biochemical diagnosis of PA without evidence for a lateralized aldosterone excess.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
complier device	complier device	-

Primary Outcome Measures

Name	Time	Method
Responders to surgery, patients not receiving aldosterone antagonists, with mean-24h-ABP < 130/80 mmHg with or without antihypertensive treatment	2 years

Secondary Outcome Measures

Name	Time	Method
Day-time and night-time ABP and circadian BP variability, number of antihypertensive agents at 1 year after surgery, prediction of post-operative complications, prediction of cardiovascular morbidity at 1 year.	2 years

Trial Locations

Locations (1)

CHU Toulouse; 🇫🇷 Toulouse, France