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

July 18, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80054
        • CHU Amiens Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group of 150 heart disease-free individuals
Other: Control group without heart disease
Control group without heart disease
Other: Patients with aortic sclerosis
Other: Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction
Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction
Other: Patients with moderate aortic stenting (RA)
Other: Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction
Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction
Other: Patients with Serious Aortic Retention
Other: Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction
Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities
Time Frame: 10 years
Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2017

Primary Completion (Actual)

June 20, 2023

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2016_843_0035

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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