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Clinical Trials/NCT02833090
NCT02833090CompletedNot Applicable

The Plasma Serotonin and Aortic Stenosis: a Pilot Study.

University Hospital, Toulouse1 site in 1 country52 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
52
Locations
1
Primary Endpoint
Measurements of 5-HT

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Group 2

Experimental

Biomarkers

Intervention: biomarkers (Procedure)

Group 1

Other

Control group had biomarkers.

Intervention: biomarkers (Procedure)

Group 3

Experimental

Biomarkers

Intervention: biomarkers (Procedure)

Group 4

Experimental

Biomarkers

Intervention: biomarkers (Procedure)

Outcomes

Primary Outcomes

Measurements of 5-HT

Time Frame: baseline

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

Secondary Outcomes

  • Measurements of acide 5-hydroxy-indol-acetic (5-HIAA)(Baseline)
  • Arterial platelet activation(Baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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