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

Not Applicable

Completed

• Conditions: Peripheral Veins Doppler Ultrasound; Acute Right Heart Failure; Pulmonary Hypertension
• Interventions: Diagnostic Test: Peripheral veins Doppler ultrasound

• Registration Number: NCT04792879
• Lead Sponsor: Poitiers University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-11
• Study Start: 2021-06-14
• Status Verified: 2022-11
• Primary Completion: 2022-11-21
• Study Completion: 2022-11-21
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peripheral veins Doppler ultrasound	Peripheral veins Doppler ultrasound	-

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index	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

Trial Locations

Locations (1)

CHU de Poitiers; 🇫🇷 Poitiers, France