The Plasma Serotonin and Aortic Stenosis: a Pilot Study.

Aortic Stenosis Clinical Trial

— SERAOPI  

Official title:

The Plasma Serotonin and Aortic Stenosis: a Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02833090
• Other study ID #: 09 238 03
• Status: Completed
• Phase: N/A
• First received: July 11, 2016
• Last updated: May 10, 2017
• Start date: February 2010
• Est. completion date: September 2012

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Group 1 : non aortic stenosis

• Goup 2, 3 and 4 : aortic stenosis

Exclusion Criteria:

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• biomarkers
transthoracic echocardiography, radial, and aortic arterial blood sampling

Locations

Country	Name	City	State
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Rouzaud-Laborde C, Delmas C, Pizzinat N, Tortosa F, Garcia C, Mialet-Perez J, Payrastre B, Sié P, Spreux-Varoquaux O, Sallerin B, Carrié D, Galinier M, Parini A, Lairez O. Platelet activation and arterial peripheral serotonin turnover in cardiac remodelin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of 5-HT	Measurement of 5-HT were performed by high pressure liquid chromatography (HPLC)	baseline
Secondary	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	Baseline
Secondary	Arterial platelet activation	Arterial platelet activation was assessed by flow cytometry analysis of platelet surface expression of P-selectin and activated integrin GPIIb/IIIa	Baseline