The Plasma Serotonin and Aortic Stenosis: a Pilot Study.

NCT ID: NCT02833090

Last Updated: 2017-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Aortic Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group 1

Control group had biomarkers.

Group Type OTHER

biomarkers

Intervention Type PROCEDURE

transthoracic echocardiography, radial, and aortic arterial blood sampling

Group 2

Biomarkers

Group Type EXPERIMENTAL

biomarkers

Intervention Type PROCEDURE

transthoracic echocardiography, radial, and aortic arterial blood sampling

Group 3

Biomarkers

Group Type EXPERIMENTAL

biomarkers

Intervention Type PROCEDURE

transthoracic echocardiography, radial, and aortic arterial blood sampling

Group 4

Biomarkers

Group Type EXPERIMENTAL

biomarkers

Intervention Type PROCEDURE

transthoracic echocardiography, radial, and aortic arterial blood sampling

Interventions

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biomarkers

transthoracic echocardiography, radial, and aortic arterial blood sampling

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Lairez, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 25242620 (View on PubMed)

Other Identifiers

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09 238 03

Identifier Type: -

Identifier Source: org_study_id

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