The Plasma Serotonin and Aortic Stenosis: a Pilot Study.

Not Applicable

Completed

• Conditions: Aortic Stenosis
• Interventions: Procedure: biomarkers

• Registration Number: NCT02833090
• Lead Sponsor: University Hospital, Toulouse

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 Timeline

• Study Start: 2010-02
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 3	biomarkers	Biomarkers
Group 4	biomarkers	Biomarkers
Group 1	biomarkers	Control group had biomarkers.
Group 2	biomarkers	Biomarkers

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Toulouse, France