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Completed

NCT Number: NCT04792879

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Poitiers

Poitiers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peripheral veins Doppler ultrasound

Diagnostic Test

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: CODOVEIN

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2021
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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