Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism

NCT01190501 | Completed DMC

• 1 other identifier: 07 326 03
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenoma

Keywords

blood pressure; antihypertensive treatments

Outcome Measures

Primary Outcomes (1)

• Responders to surgery, patients not receiving aldosterone antagonists, with mean-24h-ABP < 130/80 mmHg with or without antihypertensive treatment

  2 years

Secondary Outcomes (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.

  2 years

Study Arms (1)

complier device

EXPERIMENTAL

Device: complier device

Interventions

complier device 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.

complier device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Bernard Chamontin, MD

  University Hospital, Toulouse

  STUDY DIRECTOR

• Pierre-François Plouin, MD

  APHP-HEGP

  PRINCIPAL INVESTIGATOR

• Philippe Gosse, MD

  University Hospital, 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 27, 2010
• Study Start: June 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2015
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)