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The Plasma Serotonin and Aortic Stenosis: a Pilot Study. (SERAOPI)

Primary Purpose

Aortic Stenosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biomarkers
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Stenosis

Eligibility Criteria

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

Inclusion Criteria:

  • Group 1 : non aortic stenosis
  • Goup 2, 3 and 4 : aortic stenosis

Exclusion Criteria:

-

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Control group had biomarkers.

Biomarkers

Biomarkers

Biomarkers

Outcomes

Primary Outcome Measures

Measurements of 5-HT
Measurement of 5-HT were performed by high pressure liquid chromatography (HPLC)

Secondary Outcome Measures

Measurements of acide 5-hydroxy-indol-acetic (5-HIAA)
Measurements of 5-HT monoamine oxidase (MAO)-A-dependent degradation product, 5-HIAA, were performed by HPLC
Arterial platelet activation
Arterial platelet activation was assessed by flow cytometry analysis of platelet surface expression of P-selectin and activated integrin GPIIb/IIIa

Full Information

First Posted
July 11, 2016
Last Updated
May 10, 2017
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02833090
Brief Title
The Plasma Serotonin and Aortic Stenosis: a Pilot Study.
Acronym
SERAOPI
Official Title
The Plasma Serotonin and Aortic Stenosis: a Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (Actual)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to describe the increase in plasma serotonin or 5-hydroxytryptamine (5-HT) in patient with increased severity of aortic stenosis and increased weight cardiac muscle.
Detailed Description
Calcific aortic stenosis is the most frequent valve disease in adults. Without therapeutic strategy, this disease leads to heart failure and death. Surgical aortic valve replacement is now a well tolerated cardiac surgery leading to excellent outcomes. Until recently, calcific aortic stenosis was considered to be histopathologically degenerative or passive in origin. It is now recognized, however, as a complex cellular process with features of atherosclerosis. It has been observed that drugs may slow dawn the progression of aortic stenosis in observational studies. It has been suggested that serotonin, a monoamine neurotransmitter and a peripheral signal mediator, may be involved in the progression of aortic stenosis and also in its consequences on myocardium hypertrophy. In the blood, serotonin in mainly stored in platelets, which release serotonin involved in post-injury vasoconstriction, thrombus formation, fibrosis and atherogenesis. This study hypothesized those patients with aortic stenosis exhibit higher circulating serotonin levels than their counterparts without heart disease. In addition to circulating serotonin, its metabolite 5-HIAA will be systematically measured on all patients. This study would allow to determine the potential of plasma serotonin as a prognosis marker and perhaps suggest the discovery of new targets for treatment of aortic stenosis.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Description
Control group had biomarkers.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Biomarkers
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Biomarkers
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Biomarkers
Intervention Type
Procedure
Intervention Name(s)
biomarkers
Intervention Description
transthoracic echocardiography, radial, and aortic arterial blood sampling
Primary Outcome Measure Information:
Title
Measurements of 5-HT
Description
Measurement of 5-HT were performed by high pressure liquid chromatography (HPLC)
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Measurements of acide 5-hydroxy-indol-acetic (5-HIAA)
Description
Measurements of 5-HT monoamine oxidase (MAO)-A-dependent degradation product, 5-HIAA, were performed by HPLC
Time Frame
Baseline
Title
Arterial platelet activation
Description
Arterial platelet activation was assessed by flow cytometry analysis of platelet surface expression of P-selectin and activated integrin GPIIb/IIIa
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Group 1 : non aortic stenosis Goup 2, 3 and 4 : aortic stenosis Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Lairez, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25242620
Citation
Rouzaud-Laborde C, Delmas C, Pizzinat N, Tortosa F, Garcia C, Mialet-Perez J, Payrastre B, Sie P, Spreux-Varoquaux O, Sallerin B, Carrie D, Galinier M, Parini A, Lairez O. Platelet activation and arterial peripheral serotonin turnover in cardiac remodeling associated to aortic stenosis. Am J Hematol. 2015 Jan;90(1):15-9. doi: 10.1002/ajh.23855.
Results Reference
result

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The Plasma Serotonin and Aortic Stenosis: a Pilot Study.

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