NCT02833090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

2.6 years

First QC Date

July 11, 2016

Last Update Submit

May 10, 2017

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • Measurements of 5-HT

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

    baseline

Secondary Outcomes (2)

  • Measurements of acide 5-hydroxy-indol-acetic (5-HIAA)

    Baseline

  • Arterial platelet activation

    Baseline

Study Arms (4)

Group 1

OTHER

Control group had biomarkers.

Procedure: biomarkers

Group 2

EXPERIMENTAL

Biomarkers

Procedure: biomarkers

Group 3

EXPERIMENTAL

Biomarkers

Procedure: biomarkers

Group 4

EXPERIMENTAL

Biomarkers

Procedure: biomarkers

Interventions

biomarkersPROCEDURE

transthoracic echocardiography, radial, and aortic arterial blood sampling

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Toulouse, 31059, France

Location

Related Publications (1)

  • 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.

    PMID: 25242620RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

  • Olivier Lairez, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 14, 2016

Study Start

February 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)