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Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01190501
First received: August 25, 2010
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Aortic Stiffness is a Predictor of Blood Pressure Response After Surgery in Patients With Aldosterone Producing Adenoma.
 Device: complier device

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 110
Study Start Date: June 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190501

Contacts
Contact: Bernard Chamontin, MD 05 61 77 30 84 ext 00 33 chamontin.b@chu-toulouse.fr

Locations
France
CHU Toulouse Recruiting
Toulouse, France, 31059
Contact: Bernard Chamontin, MD            
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01190501     History of Changes
Other Study ID Numbers: 07 326 03
Study First Received: August 25, 2010
Last Updated: January 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 19, 2013