Trial record 10 of 17 for:    Aldosterone-producing adenoma

Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01190501
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Adenoma Device: complier device Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism
Study Start Date : June 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: complier device 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.

Primary Outcome Measures :
  1. Responders to surgery, patients not receiving aldosterone antagonists, with mean-24h-ABP < 130/80 mmHg with or without antihypertensive treatment [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01190501

CHU Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
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

Responsible Party: University Hospital, Toulouse Identifier: NCT01190501     History of Changes
Other Study ID Numbers: 07 326 03
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Toulouse:
blood pressure
antihypertensive treatments

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases