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

NCT04792879 | Completed

• 1 other identifier: 2021-A00100-41
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  Inclusion day within 4 hours before the right heart catheterization

Study Arms (1)

Peripheral veins Doppler ultrasound

EXPERIMENTAL

Diagnostic Test: Peripheral veins Doppler ultrasound

Interventions

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.

Peripheral veins Doppler ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU de Poitiers

Poitiers, France

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: June 14, 2021
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

FR (1)