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

Advanced Heart Failure Clinical Trial

— US-IJVD-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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03874312
• Other study ID #: 371-072017
• Status: Active, not recruiting
• Start date: October 18, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: February 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Heart Failure
• Congestion, Venous
• Heart Failure
• Hyperemia
• Systolic Chronic Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Italy	De Gasperis Cardio Center, Niguarda Hospital	Milano	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

McGee SR. Physical examination of venous pressure: a critical review. Am Heart J. 1998 Jul;136(1):10-8. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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