Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism
18 Years
N/A
Both
Aortic Stiffness is a Predictor of Blood Pressure Response After Surgery in Patients With Aldosterone Producing Adenoma.
Trial Information
Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism
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.
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
- informed written consent obtained from each participant
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Responders to surgery, patients not receiving aldosterone antagonists, with mean-24h-ABP < 130/80 mmHg with or without antihypertensive treatment
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Bernard Chamontin, MD
Investigator Role:
Study Director
Investigator Affiliation:
CHU Toulouse
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
07 326 03
NCT ID:
NCT01190501
Start Date:
June 2009
Completion Date:
December 2013
Related Keywords:
- Aortic Stiffness is a Predictor of Blood Pressure Response After Surgery in Patients With Aldosterone Producing Adenoma.
- blood pressure, antihypertensive treatments.
- Adenoma
- Hyperaldosteronism
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