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

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: Pulmonary Hypertension; Acute Right Heart Failure; Peripheral Veins Doppler Ultrasound
• Intervention / Treatment: Diagnostic test: Peripheral veins Doppler ultrasound

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France
    • CHU de Poitiers

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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

• Sponsor: Poitiers University Hospital

Study record dates

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: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Heart Failure; Hypertension; Hypertension, Pulmonary
• 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