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

T

Toulouse University Hospital

Status

Completed

Conditions

Aortic Stenosis

Treatments

Procedure: biomarkers

Study type

Interventional

Funder types

Other

Identifiers

NCT02833090
09 238 03

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

52 participants in 4 patient groups

Group 1
Other group
Description:
Control group had biomarkers.
Treatment:
Procedure: biomarkers
Group 2
Experimental group
Description:
Biomarkers
Treatment:
Procedure: biomarkers
Group 3
Experimental group
Description:
Biomarkers
Treatment:
Procedure: biomarkers
Group 4
Experimental group
Description:
Biomarkers
Treatment:
Procedure: biomarkers

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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