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Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis (VOPRABIO)

Primary Purpose

Pulse Wave, Aortic Stenosis

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction
Control group without heart disease
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pulse Wave

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years of age, without legal protection (guardianship or curatorship),
  • Stable hemodynamic status.
  • Affiliation to a social security scheme

Exclusion Criteria:

  • Hemodynamically unstable patients: Systolic PA <10 cmHg, rapid peripheral pulse and spinning, mottling, obnubilation, oliguria, sweating, coma
  • History of significant valvulopathy other than an aortic stenosis,
  • Pregnancy.
  • Patient under tutelage or curatelle or deprived of public right.

Sites / Locations

  • CHU Amiens Picardie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Control group of 150 heart disease-free individuals

Patients with aortic sclerosis

Patients with moderate aortic stenting (RA)

Patients with Serious Aortic Retention

Arm Description

Outcomes

Primary Outcome Measures

Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities
Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities

Secondary Outcome Measures

Full Information

First Posted
April 14, 2017
Last Updated
July 18, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03140735
Brief Title
Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis
Acronym
VOPRABIO
Official Title
Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Withdrawn
Why Stopped
no participants enrolled
Study Start Date
July 3, 2017 (Actual)
Primary Completion Date
June 20, 2023 (Actual)
Study Completion Date
June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Aortic valve pathology is the third most common cardiovascular disease after coronary artery disease and hypertension, which is responsible for severe morbidity and mortality in elderly patients and requires surgical treatment in its most severe form of progression. The purpose of this study is to find a link between arterial stiffness and degenerative aortic stenosis. If this link is established, arterial stiffness may become a medical therapeutic target in order to delay the evolution of the disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulse Wave, Aortic Stenosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group of 150 heart disease-free individuals
Arm Type
Other
Arm Title
Patients with aortic sclerosis
Arm Type
Other
Arm Title
Patients with moderate aortic stenting (RA)
Arm Type
Other
Arm Title
Patients with Serious Aortic Retention
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction
Intervention Description
Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction
Intervention Type
Other
Intervention Name(s)
Control group without heart disease
Intervention Description
Control group without heart disease
Primary Outcome Measure Information:
Title
Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities
Description
Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years of age, without legal protection (guardianship or curatorship), Stable hemodynamic status. Affiliation to a social security scheme Exclusion Criteria: Hemodynamically unstable patients: Systolic PA <10 cmHg, rapid peripheral pulse and spinning, mottling, obnubilation, oliguria, sweating, coma History of significant valvulopathy other than an aortic stenosis, Pregnancy. Patient under tutelage or curatelle or deprived of public right.
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Learn more about this trial

Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis

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