Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism

Adenoma Clinical Trial

Official title:

Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190501
• Other study ID #: 07 326 03
• Status: Completed
• Phase: N/A
• First received: August 25, 2010
• Last updated: February 21, 2017
• Start date: June 2009
• Est. completion date: June 2015

Study information

• Verified date: February 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Hyperaldosteronism

Intervention

Device:
• complier device
The procedure of use of complier has to follow the recommendations for standardization of subject conditions. Assessment of arterial distensibility: pulse wave velocity (PWV), aortic stiffness is assessed by PWV which is a classic index of arterial stiffness. A semi-automatic device is used to measure carotid-femoral PWV. The distance covered by the pulse wave is measured on the surface of the body and represented the distance between the 2 recording sites.

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responders to surgery, patients not receiving aldosterone antagonists, with mean-24h-ABP < 130/80 mmHg with or without antihypertensive treatment		2 years
Secondary	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