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Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism

T

Toulouse University Hospital

Status

Completed

Conditions

Adenoma

Treatments

Device: complier device

Study type

Interventional

Funder types

Other

Identifiers

NCT01190501
07 326 03

Details and patient eligibility

About

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.

Full 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.

Enrollment

96 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

96 participants in 1 patient group

complier device
Experimental group
Treatment:
Device: complier device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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