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Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism

Primary Purpose

Adenoma

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

complier device

About this trial

This is an interventional diagnostic trial for Adenoma focused on measuring blood pressure, antihypertensive treatments

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHU Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

complier device

Arm Description

Outcomes

Primary Outcome Measures

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

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.

Full Information

NCT ID

NCT01190501

First Posted

August 25, 2010

Last Updated

February 21, 2017

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT01190501

Brief Title

Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism

Official Title

Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenoma

Keywords

blood pressure, antihypertensive treatments

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

complier device

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

complier device

Intervention Description

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 Measure Information:

Title

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 Measure Information:

Title

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Overall Study Officials: