Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism
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.
Aortic Stiffness is a Predictor of Blood Pressure Response After Surgery in Patients With Aldosterone Producing Adenoma.
Device: complier device
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism|
- Responders to surgery, patients not receiving aldosterone antagonists, with mean-24h-ABP < 130/80 mmHg with or without antihypertensive treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||June 2015|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Device: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190501
|Toulouse, France, 31059|
|Study Director:||Bernard Chamontin, MD||CHU Toulouse|
|Principal Investigator:||Pierre-François Plouin, MD||APHP-HEGP|
|Principal Investigator:||Philippe Gosse, MD||CHU Bordeaux|
|Principal Investigator:||Jean-Philippe Baguet, MD||CHU Grenoble michalon|
|Principal Investigator:||Pierre Lantelme, MD||Hospices de Lyon|
|Principal Investigator:||Xavier Girerd, MD||APHP-Pitié Salpêtrière|
|Principal Investigator:||Claire Mounier-Vehier, MD||CHR Lille|
|Principal Investigator:||Yves Resnik, MD||CHU caen Côte de Nacre|