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

NCT ID: NCT04792879

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-14
• Study Completion Date: 2022-11-21

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.

Conditions

Acute Right Heart Failure; Pulmonary Hypertension; Peripheral Veins Doppler Ultrasound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Peripheral veins Doppler ultrasound

Group Type: EXPERIMENTAL

Peripheral veins Doppler ultrasound

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Poitiers

Poitiers, , France

Countries

France

Other Identifiers

2021-A00100-41

Identifier Type: -

Identifier Source: org_study_id