Adenoma
Conditions
Keywords
blood pressure, antihypertensive treatments
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.
Interventions
DEVICEcomplier 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.
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responders to surgery, patients not receiving aldosterone antagonists, with mean-24h-ABP < 130/80 mmHg with or without antihypertensive treatment | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed