Back to resultsAssessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension (CODOVEIN)
Primary Purpose
Acute Right Heart Failure, Pulmonary Hypertension, Peripheral Veins Doppler Ultrasound
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Peripheral veins Doppler ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Right Heart Failure
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.
Sites / Locations
- CHU de Poitiers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peripheral veins Doppler ultrasound
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04792879
First Posted
March 8, 2021
Last Updated
November 30, 2022
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04792879
Brief Title
Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension
Acronym
CODOVEIN
Official Title
Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
November 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Right Heart Failure, Pulmonary Hypertension, Peripheral Veins Doppler Ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peripheral veins Doppler ultrasound
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Peripheral veins Doppler ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
12. IPD Sharing Statement
Learn more about this trial
Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension
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