Acute Right Heart FailureCODOVEINNCT04792879
Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension
A study testing Peripheral veins Doppler ultrasound in people with Acute Right Heart Failure and Pulmonary Hypertension, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Right Heart Failure, Pulmonary Hypertension, Peripheral Veins Doppler Ultrasound
- What is being tested?
- Peripheral veins Doppler ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2021to 21 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Peripheral veins Doppler ultrasound
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral veins Doppler ultrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral veins Doppler ultrasound | Experimental | Not described Receives: Diagnostic Test: Peripheral veins Doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Inclusion day within 4 hours before the right heart catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start14 Jun 2021
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Right Heart FailureStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792879
- Sponsor's protocol ID
- 2021-A00100-41
- Acronym
- CODOVEIN
- Status last verified
- Nov 2022
- First submitted
- 8 Mar 2021
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT04792879
- Acronym / sponsor ID
- CODOVEIN / 2021-A00100-41
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral veins Doppler ultrasound | Experimental | Diagnostic Test: Peripheral veins Doppler ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral veins Doppler ultrasoundPatients 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. | Diagnostic test | Peripheral veins Doppler ultrasound |
Primary outcome
Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral veins Doppler ultrasound in people with Acute Right Heart Failure and Pulmonary Hypertension, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index (time frame: Inclusion day within 4 hours before the right heart catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.