Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Adenoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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complier device

Group Type EXPERIMENTAL

complier device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No