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CompletedNCT04792879CODOVEINUpdated Dec 1, 2022

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

An interventional study of Peripheral veins Doppler ultrasound in Acute Right Heart Failure, Pulmonary Hypertension and Peripheral Veins Doppler Ultrasound, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-01.

Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Right Heart Failure
  • Pulmonary Hypertension
  • Peripheral Veins Doppler Ultrasound
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 103 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    Peripheral veins Doppler ultrasound

    Diagnostic Test: Peripheral veins Doppler ultrasound

Interventions

  • Diagnostic testPeripheral 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Inclusion day within 4 hours before the right heart catheterization

07

Study locations

1 site
  • CHU de Poitiers
    Poitiers, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04792879
Lead sponsor
Poitiers University Hospital
Responsible party
Sponsor
First posted
Mar 11, 2021
Start date
Jun 14, 2021
Primary completion
Nov 21, 2022
Completion
Nov 21, 2022
Last update
Dec 1, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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