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

Pulmonary Hypertension Clinical Trial

— CODOVEIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792879
• Other study ID #: 2021-A00100-41
• Status: Completed
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: November 21, 2022

Study information

• Verified date: November 2022
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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