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

Advanced Heart Failure Clinical Trial

Official title: Ultrasound-assessed Internal Jugular Vein Distensibility to Predict Right Atrial Pressure and Other Hemodynamic Parameters in Patients With Advanced Chronic Heart Failure

Status Active, not recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03874312
• Study type: Observational
• Source: Niguarda Hospital
• Status: Active, not recruiting
• Start date: October 18, 2017
• Completion date: December 31, 2022