Clinical trial NCT01190501: Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism
Official title: Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma
Keywords: blood pressure
antihypertensive treatments
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2010-08-27
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Responders to surgery, patients not receiving aldosterone antagonists, with mean-24h-ABP < 130/80 mmHg with or without antihypertensive treatment
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Bernard Chamontin, MD
role: STUDY_DIRECTOR
affiliation: APHP-HEGP
name: Pierre-François Plouin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Philippe Gosse, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Grenoble michalon
name: Jean-Philippe Baguet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices de Lyon
name: Pierre Lantelme, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP-Pitié Salpêtrière
name: Xavier Girerd, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR Lille
name: Claire Mounier-Vehier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU caen Côte de Nacre
name: Yves Resnik, MD
role: PRINCIPAL_INVESTIGATOR
References: