- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01190501
Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31059
- CHU Toulouse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Responders to surgery, patients not receiving aldosterone antagonists, with mean-24h-ABP < 130/80 mmHg with or without antihypertensive treatment
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome 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.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07 326 03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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