Systolic Chronic Heart FailureUS-IJVD-CHFNCT03874312
Ultrasound-assessed Internal Jugular Vein Distensibility in Advanced Chronic Heart Failure (US-IJVD in CHF)
An observational study of Systolic Chronic Heart Failure and Congestion, Venous, run by Niguarda Hospital at 1 site in Italy.
Trial summary
Prospective validation of the ultrasound-assessed internal jugular vein distensibility (JVD) ratio to identify patients with systolic chronic heart failure and right atrial pressure (RAP) of 7 or less mmHg measured by the right heart catheterization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systolic Chronic Heart Failure, Congestion, Venous, Advanced Heart Failure
- What is being tested?
- Linear ultrasound (US) assessment of the internal jugular vein
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 18 Oct 2017to 31 Dec 2022
- Phase
- Observational
- 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
Study population: Patients with systolic chronic heart failure defined by a left ventricular ejection fraction (LVEF) <50% on echocardiogram that, undergo elective RHC in the heart transplant/left ventricular assist device work-up. All procedure, RHC, ultrasound assessment of the IJV, echocardiogram, laboratory test exams are routine exams in the heart transplant/left ventricular assist device work-up or in the staging of patients with advanced HF. No adjunctive procedures have been performed for this specific study.
Who may be able to join
- All patients with systolic chronic heart failure defined by a left ventricular ejection fraction (LVEF) <50% on echocardiogram that, undergo elective RHC in the heart transplant/left ventricular assist device work-up.
- In case of occlusion of the left internal jugular vein (IJV), the RHC is performed from to contralateral IJV, and US-assessed JVD ratio will be measured on the right IJV.
Who cannot join
- Patients supported by a left ventricular assist device.
- Patients with acute heart failure that undergo RHC as an urgent procedure in hemodynamically unstable patients.
- Patients unable/unwilling to sign a written informed consent.
- Patients in which an RHC is not feasible from an internal jugular vein.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-assessed Internal Jugular Vein Distensibility to Predict Right Atrial Pressure and Other Hemodynamic Parameters in Patients With Advanced Chronic Heart Failure
Prospective validation of the ultrasound-assessed internal jugular vein distensibility (JVD) ratio to identify patients with systolic chronic heart failure and right atrial pressure (RAP) of 7 or less mmHg measured by the right heart catheterization. In a calibration cohort, a threshold ratio will be identified, above which the RAP is normal with the highest accuracy. This diagnostic tool with a defined threshold of the JVD ratio will be assessed in a second prospective validation cohort.
Read the detailed description
Peripheral congestion is caused by an excess of fluid in tissues and vessels. Fluid overload is associated with poor outcome in heart failure (HF)(1). Several clinical signs can suggest peripheral congestion, such as peripheral edema or neck vein distention. In particular, the clinical sign of the neck jugular vein distention is used to estimate right atrial pressure (RHC) and is associated with fluid overload and congestion. Nevertheless, clinical assessment is somewhat subjective depending on the anatomy of the patient's neck and on the expertise of the physician (2). It has been reported that the detection of elevated RAP can be measured using a bedside ultrasound (US)(3). In this study, the Authors compared the jugular vein distensibility (IVD) ratio assessed with US with the invasive measure of the RAP reporting a good accuracy in detecting normal RAP. They showed a good performance of this diagnostic test, nevertheless, they evaluated this diagnostic test in a mix population including only 27 patients with congestive HF. More recent studies showed the prognostic value of the IVD ratio in patients with HF (4). Nevertheless, a specific threshold of the internal JVD ratio to identify patients with normal RAP in the setting of patients with systolic chronic HF (CHF) has never been described. Furthermore, in patients with CHF clinical signs of congestion cannot always be evident at clinical examination, making the decision to modify diuretic dosage or to introduce vasodilator drugs uneasy. Thus, a convenient, accurate, and reproducible non-invasive tool to identify patients with normal RAP (normal mean RAP is 7 or less mmHg) patients with systolic CHF would be desirable to tailor therapy, in particular in outpatient clinics.
The main hypothesis of this study is that US-assessment of the internal JVD could be an accurate diagnostic tool to identify patients with normal RAP in this challenging set of patients.
The primary aim of the study prospectively validates an US-assessed internal JVD ratio to identify patients with systolic CHF and RAP of 7 or less mmHg measured by RHC. In a calibration cohort, a threshold of the JVD ratio above which the RAP is normal with the highest accuracy will be identified and then this diagnostic tool with a defined JVD ratio will be validated in a second prospective validation cohort.
- Being tested
- Linear ultrasound (US) assessment of the internal jugular vein
- Keywords
- right heart catheterization, Peripheral congestion, Right atrial pressure, Internal jugular vein distention ratio, ultrasound of jugular vein, chronic heart failure
- Medical subject headings
- Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear ultrasound (US) assessment of the internal jugular veinDiagnostic test
Evaluation of jugular vein distensibility at rest and after Valsalva maneuver by US at the time of the RHC. US-guided IJV is routinely performed at the time of vein cannulation.
| Study group | Role | What they receive |
|---|---|---|
| Calibration group | Patients with systolic chronic heart failure who undergo right heart catheterization (RHC) for heart transplant/left ventricular assist device workup. Receives: Diagnostic Test: Linear ultrasound (US) assessment of the internal jugular vein | |
| Validation group | Patients with systolic chronic heart failure who undergo RHC for heart transplant/left ventricular assist device workup. Receives: Diagnostic Test: Linear ultrasound (US) assessment of the internal jugular vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of patients with normal RAP (=<7 mmHg) with US-IJVD based on the JVD ratio obtained from the calibration cohort.
Positive predictive value (PPV) of the JVD ratio to identify patients with normal (RAP=<7 mmHg) measured by RHC in the validation group. In particular a higher JVD ratio indicated lower RAP.
Measured: From July 2017 to June 2019
Secondary outcomes (1)
Clinical major cardiac events among patients included in the calibration group divided on the basis of the JVD ratio
Clinical events include cardiac death, unknown death, cardiac hospitalization, urgent heart transplant, left ventricular assist device implantation. In particular it is expected that patients with JVD ratio above the identified threshold in the calibration group have a better outcome.
Measured: From July 2017 to June 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start18 Oct 2017
- Primary completion27 Feb 2019
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Systolic Chronic Heart FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrico Ammirati, MD, PhD, Principal investigator, Niguarda Hospital, Milano, ItalyFabrizio Oliva, MD, Study director, Niguarda Hospital, Milano, ItalyDavide Marchetti, MD, Study chair, Università Statale di Milano, ItalyAndrea Garascia, MD, Study chair, Niguarda Hospital, Milano, italyGiada Colombo, Study chair, Università Statale di Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874312
- Sponsor's protocol ID
- 371-072017
- Acronym
- US-IJVD-CHF
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2019
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The informed consent does not include to make public the individual participant data
Publications
Caldentey G, Khairy P, Roy D, Leduc H, Talajic M, Racine N, White M, O'Meara E, Guertin MC, Rouleau JL, Ducharme A. Prognostic value of the physical examination in patients with heart failure and atrial fibrillation: insights from the AF-CHF trial (atrial fibrillation and chronic heart failure). JACC Heart Fail. 2014 Feb;2(1):15-23. doi: 10.1016/j.jchf.2013.10.004. Epub 2014 Jan 8.
PubMed 24622114McGee SR. Physical examination of venous pressure: a critical review. Am Heart J. 1998 Jul;136(1):10-8. doi: 10.1016/s0002-8703(98)70175-9.
PubMed 9665212Simon MA, Kliner DE, Girod JP, Moguillansky D, Villanueva FS, Pacella JJ. Detection of elevated right atrial pressure using a simple bedside ultrasound measure. Am Heart J. 2010 Mar;159(3):421-7. doi: 10.1016/j.ahj.2010.01.004.
PubMed 20211304Pellicori P, Kallvikbacka-Bennett A, Dierckx R, Zhang J, Putzu P, Cuthbert J, Boyalla V, Shoaib A, Clark AL, Cleland JG. Prognostic significance of ultrasound-assessed jugular vein distensibility in heart failure. Heart. 2015 Jul;101(14):1149-58. doi: 10.1136/heartjnl-2015-307558. Epub 2015 May 25.
PubMed 26006717Ammirati E, Marchetti D, Colombo G, Pellicori P, Gentile P, D'Angelo L, Masciocco G, Verde A, Macera F, Brunelli D, Occhi L, Musca F, Perna E, Bernasconi DP, Moreo A, Camici PG, Metra M, Oliva F, Garascia A. Estimation of Right Atrial Pressure by Ultrasound-Assessed Jugular Vein Distensibility in Patients With Heart Failure. Circ Heart Fail. 2024 Feb;17(2):e010973. doi: 10.1161/CIRCHEARTFAILURE.123.010973. Epub 2024 Feb 1.
PubMed 38299348
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-assessed Internal Jugular Vein Distensibility to Predict Right Atrial Pressure and Other Hemodynamic Parameters in Patients With Advanced Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT03874312
- Acronym / sponsor ID
- US-IJVD-CHF / 371-072017
- Keywords
- right heart catheterization, Peripheral congestion, Right atrial pressure, Internal jugular vein distention ratio, ultrasound of jugular vein, chronic heart failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Mar 2019 (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.
Prospective validation of the ultrasound-assessed internal jugular vein distensibility (JVD) ratio to identify patients with systolic chronic heart failure and right atrial pressure (RAP) of 7 or less mmHg measured by the right heart catheterization. In a calibration cohort, a threshold ratio will be identified, above which the RAP is normal with the highest accuracy. This diagnostic tool with a defined threshold of the JVD ratio will be assessed in a second prospective validation cohort.
Detailed description
Peripheral congestion is caused by an excess of fluid in tissues and vessels. Fluid overload is associated with poor outcome in heart failure (HF)(1). Several clinical signs can suggest peripheral congestion, such as peripheral edema or neck vein distention. In particular, the clinical sign of the neck jugular vein distention is used to estimate right atrial pressure (RHC) and is associated with fluid overload and congestion. Nevertheless, clinical assessment is somewhat subjective depending on the anatomy of the patient's neck and on the expertise of the physician (2). It has been reported that the detection of elevated RAP can be measured using a bedside ultrasound (US)(3). In this study, the Authors compared the jugular vein distensibility (IVD) ratio assessed with US with the invasive measure of the RAP reporting a good accuracy in detecting normal RAP. They showed a good performance of this diagnostic test, nevertheless, they evaluated this diagnostic test in a mix population including only 27 patients with congestive HF. More recent studies showed the prognostic value of the IVD ratio in patients with HF (4). Nevertheless, a specific threshold of the internal JVD ratio to identify patients with normal RAP in the setting of patients with systolic chronic HF (CHF) has never been described. Furthermore, in patients with CHF clinical signs of congestion cannot always be evident at clinical examination, making the decision to modify diuretic dosage or to introduce vasodilator drugs uneasy. Thus, a convenient, accurate, and reproducible non-invasive tool to identify patients with normal RAP (normal mean RAP is 7 or less mmHg) patients with systolic CHF would be desirable to tailor therapy, in particular in outpatient clinics.
The main hypothesis of this study is that US-assessment of the internal JVD could be an accurate diagnostic tool to identify patients with normal RAP in this challenging set of patients.
The primary aim of the study prospectively validates an US-assessed internal JVD ratio to identify patients with systolic CHF and RAP of 7 or less mmHg measured by RHC. In a calibration cohort, a threshold of the JVD ratio above which the RAP is normal with the highest accuracy will be identified and then this diagnostic tool with a defined JVD ratio will be validated in a second prospective validation cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calibration group | – | Diagnostic Test: Linear ultrasound (US) assessment of the internal jugular veinPatients with systolic chronic heart failure who undergo right heart catheterization (RHC) for heart transplant/left ventricular assist device workup. |
| Validation group | – | Diagnostic Test: Linear ultrasound (US) assessment of the internal jugular veinPatients with systolic chronic heart failure who undergo RHC for heart transplant/left ventricular assist device workup. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systolic chronic heart failure defined by a left ventricular ejection fraction (LVEF) <50% on echocardiogram that, undergo elective RHC in the heart transplant/left ventricular assist device work-up. All procedure, RHC, ultrasound assessment of the IJV, echocardiogram, laboratory test exams are routine exams in the heart transplant/left ventricular assist device work-up or in the staging of patients with advanced HF. No adjunctive procedures have been performed for this specific study.
Key inclusion criteria (2 listed)
- All patients with systolic chronic heart failure defined by a left ventricular ejection fraction (LVEF) <50% on echocardiogram that, undergo elective RHC in the heart transplant/left ventricular assist device work-up.
- In case of occlusion of the left internal jugular vein (IJV), the RHC is performed from to contralateral IJV, and US-assessed JVD ratio will be measured on the right IJV.
Key exclusion criteria (4 listed)
- Patients supported by a left ventricular assist device.
- Patients with acute heart failure that undergo RHC as an urgent procedure in hemodynamically unstable patients.
- Patients unable/unwilling to sign a written informed consent.
- Patients in which an RHC is not feasible from an internal jugular vein.
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 |
|---|---|---|
| Linear ultrasound (US) assessment of the internal jugular veinEvaluation of jugular vein distensibility at rest and after Valsalva maneuver by US at the time of the RHC. US-guided IJV is routinely performed at the time of vein cannulation. | Diagnostic test | Calibration group, Validation group |
Primary outcome
Identification of patients with normal RAP (=<7 mmHg) with US-IJVD based on the JVD ratio obtained from the calibration cohort.
Time frame: From July 2017 to June 2019
Positive predictive value (PPV) of the JVD ratio to identify patients with normal (RAP=<7 mmHg) measured by RHC in the validation group. In particular a higher JVD ratio indicated lower RAP.
1 secondary outcome
Clinical major cardiac events among patients included in the calibration group divided on the basis of the JVD ratio
Time frame: From July 2017 to June 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Background: PubMed 24622114Caldentey G, Khairy P, Roy D, Leduc H, Talajic M, Racine N, White M, O'Meara E, Guertin MC, Rouleau JL, Ducharme A. Prognostic value of the physical examination in patients with heart failure and atrial fibrillation: insights from the AF-CHF trial (atrial fibrillation and chronic heart failure). JACC Heart Fail. 2014 Feb;2(1):15-23. doi: 10.1016/j.jchf.2013.10.004. Epub 2014 Jan 8.
- Background: PubMed 9665212McGee SR. Physical examination of venous pressure: a critical review. Am Heart J. 1998 Jul;136(1):10-8. doi: 10.1016/s0002-8703(98)70175-9.
- Background: PubMed 20211304Simon MA, Kliner DE, Girod JP, Moguillansky D, Villanueva FS, Pacella JJ. Detection of elevated right atrial pressure using a simple bedside ultrasound measure. Am Heart J. 2010 Mar;159(3):421-7. doi: 10.1016/j.ahj.2010.01.004.
- Background: PubMed 26006717Pellicori P, Kallvikbacka-Bennett A, Dierckx R, Zhang J, Putzu P, Cuthbert J, Boyalla V, Shoaib A, Clark AL, Cleland JG. Prognostic significance of ultrasound-assessed jugular vein distensibility in heart failure. Heart. 2015 Jul;101(14):1149-58. doi: 10.1136/heartjnl-2015-307558. Epub 2015 May 25.
- Derived from this study: PubMed 38299348Ammirati E, Marchetti D, Colombo G, Pellicori P, Gentile P, D'Angelo L, Masciocco G, Verde A, Macera F, Brunelli D, Occhi L, Musca F, Perna E, Bernasconi DP, Moreo A, Camici PG, Metra M, Oliva F, Garascia A. Estimation of Right Atrial Pressure by Ultrasound-Assessed Jugular Vein Distensibility in Patients With Heart Failure. Circ Heart Fail. 2024 Feb;17(2):e010973. doi: 10.1161/CIRCHEARTFAILURE.123.010973. Epub 2024 Feb 1.
- Individual participant dataSharing planned: No. The informed consent does not include to make public the individual participant data
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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.
Enrico Ammirati, MD, PhD principal investigator
Niguarda Hospital, Milano, Italy
Fabrizio Oliva, MD study director
Niguarda Hospital, Milano, Italy
Davide Marchetti, MD study chair
Università Statale di Milano, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systolic Chronic Heart Failure and Congestion, Venous, run by Niguarda Hospital at 1 site in Italy.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Mar 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 Italy. 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?
Results are not available in the source record.
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?
Identification of patients with normal RAP (=<7 mmHg) with US-IJVD based on the JVD ratio obtained from the calibration cohort. (time frame: From July 2017 to June 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03874312, which also lists 5 linked publications.
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 21 Mar 2022.