Clinical trial NCT03874312: Ultrasound-assessed Internal Jugular Vein Distensibility in Advanced Chronic Heart Failure (US-IJVD in CHF)
Official title: Ultrasound-assessed Internal Jugular Vein Distensibility to Predict Right Atrial Pressure and Other Hemodynamic Parameters in Patients With Advanced Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systolic Chronic Heart Failure
Congestion, Venous
Advanced Heart Failure
Keywords: right heart catheterization
Peripheral congestion
Right atrial pressure
Internal jugular vein distention ratio
ultrasound of jugular vein
chronic heart failure
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identification of patients with normal RAP (=<7 mmHg) with US-IJVD based on the JVD ratio obtained from the calibration cohort.
timeFrame: From July 2017 to June 2019
Secondary outcomes:
measure: Clinical major cardiac events among patients included in the calibration group divided on the basis of the JVD ratio
timeFrame: From July 2017 to June 2019
Other outcomes:
measure: Relationship between JVD ratio and other hemodynamic parameters obtained by RHC
timeFrame: From July 2017 to June 2019
Locations:
city: Milano
country: Italy
facility: De Gasperis Cardio Center, Niguarda Hospital
state: Lombardy
Study officials:
affiliation: Niguarda Hospital, Milano, Italy
name: Enrico Ammirati, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Niguarda Hospital, Milano, Italy
name: Fabrizio Oliva, MD
role: STUDY_DIRECTOR
affiliation: Università Statale di Milano, Italy
name: Davide Marchetti, MD
role: STUDY_CHAIR
affiliation: Niguarda Hospital, Milano, italy
name: Andrea Garascia, MD
role: STUDY_CHAIR
affiliation: Università Statale di Milano, Italy
name: Giada Colombo
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.