Ultrasound-assessed Internal Jugular Vein Distensibility in Advanced Chronic Heart Failure (US-IJVD in CHF) (US-IJVD-CHF)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Heart Failure; Congestion, Venous; Systolic Chronic Heart Failure
• Intervention / Treatment: Diagnostic test: Linear ultrasound (US) assessment of the internal jugular vein

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Milano, Lombardy, Italy, 20162
      • De Gasperis Cardio Center, Niguarda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Calibration group; Patients with systolic chronic heart failure who undergo right heart catheterization (RHC) for heart transplant/left ventricular assist device workup.	Diagnostic test: Linear ultrasound (US) assessment of the internal jugular vein; 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.
Validation group; Patients with systolic chronic heart failure who undergo RHC for heart transplant/left ventricular assist device workup.	Diagnostic test: Linear ultrasound (US) assessment of the internal jugular vein; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From July 2017 to June 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From July 2017 to June 2019

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between JVD ratio and other hemodynamic parameters obtained by RHC	The hemodynamic parameters will include pulmonary artery pressures and pulmonary capillary wedge pressure	From July 2017 to June 2019

Collaborators and Investigators

• Sponsor: Niguarda Hospital
• Investigators: Principal Investigator: Enrico Ammirati, MD, PhD, Niguarda Hospital, Milano, Italy; Study Director: Fabrizio Oliva, MD, Niguarda Hospital, Milano, Italy; Study Chair: Davide Marchetti, MD, Università Statale di Milano, Italy; Study Chair: Andrea Garascia, MD, Niguarda Hospital, Milano, Italy; Study Chair: Giada Colombo, Università Statale di Milano, Italy

Publications and helpful links

General 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.
• McGee 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.
• Simon 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.
• Pellicori 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2017
• Primary Completion (Actual): February 27, 2019
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: chronic heart failure; right heart catheterization; Peripheral congestion; Right atrial pressure; Internal jugular vein distention ratio; ultrasound of jugular vein
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Failure; Hyperemia
• Other Study ID Numbers: 371-072017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The informed consent does not include to make public the individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No