Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension (CODOVEIN)

November 30, 2022 updated by: Poitiers University Hospital
Occurrence of acute right heart failure (ARHF) remains common during pulmonary hypertension (PH). Right atrial pressure (RAP) invasive measurement is the gold standard to diagnose ARHF in order to improve diuretic treatment management. Existence of indirect signs of ARHF on venous Doppler ultrasound waveform has long been described, but correlation with RAP has not been properly established yet. It is the aim of our study in order to obtain an additional tool to manage ARHF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

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
      • Poitiers, France
        • CHU De Poitiers

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patient (age ≥ 18 years old)
  • Patient referred to the cardiology department for a right heart catheterization with measurement of RAP, regardless of the indication.
  • Free subject, without guardianship or curatorship or subordination
  • People affiliated to or beneficiary of a social security schemes
  • Informed consent signed by the patient after clear and fair information about the study.

Exclusion Criteria:

  • Minor patient (age < 18 years)
  • Refusal to participate in the study
  • Patient with hemodynamic instability, unable to tolerate a delay in treatment caused by the ultrasound examination.
  • Patient requiring diuretic treatment within the next 4 hours
  • Patient with a life expectancy of less than 24 hours.
  • History of proximal deep venous thrombosis involving the inferior vena cava and/or common iliac veins and/or femoral veins.
  • History of extrinsic venous compression on the inferior vena cava and/or common iliac veins and/or femoral veins.
  • Persons who do not benefit from a Social Security scheme or who do not benefit from it through a third party.
  • Persons benefiting from reinforced protection, namely minors, pregnant and nursing women, persons deprived of liberty by a judicial or administrative decision, persons staying in health or social institutions, adults under legal protection and finally patients in emergency situations.

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peripheral veins Doppler ultrasound
Diagnostic test: Peripheral veins Doppler ultrasound
Patients undergoing a right heart catheterization for PH diagnosis or annual follow-up in the cardiological unit of the university hospital of Poitiers will be included. A venous Doppler ultrasound will be performed by a vascular physician, with experience in vascular ultrasound imaging, within 4 hours before the right heart catheterization. Morphological parameters of vena cava, and velocimetric parameters of femoral, jugular and supra-hepatic veins will be assessed in order to study their correlation with right auricular pressure value.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index
Time Frame: Inclusion day within 4 hours before the right heart catheterization

Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index*, measured by Pulsed Doppler on common femoral veins, as a diagnostic criterion for ARHF (defined by RAP ≥10 mm Hg).

* Defined as duration of non-anterograde venous flow during 3 seconds/ 3 seconds
Inclusion day within 4 hours before the right heart catheterization

Collaborators and Investigators

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

Sponsor

Poitiers University Hospital

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)

June 14, 2021

Primary Completion (Actual)

November 21, 2022

Study Completion (Actual)

November 21, 2022

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A00100-41

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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