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

NCT03874312 | Unknown

• 1 other identifier: 371-072017
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical major cardiac events among patients included in the calibration group divided on the basis of the JVD ratio

  From July 2017 to June 2019

Other Outcomes (1)

• Relationship between JVD ratio and other hemodynamic parameters obtained by RHC

  From July 2017 to June 2019

Study Arms (2)

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

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

Interventions

Linear ultrasound (US) assessment of the internal jugular vein DIAGNOSTIC_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.

Calibration group; Validation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

De Gasperis Cardio Center, Niguarda Hospital

Milan, Lombardy, 20162, Italy

Location

Related Publications (5)

• 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.

  PMID: 24622114 BACKGROUND

• 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.

  PMID: 9665212 BACKGROUND

• 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.

  PMID: 20211304 BACKGROUND

• 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.

  PMID: 26006717 BACKGROUND

• Ammirati 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.

  PMID: 38299348 DERIVED

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Enrico Ammirati, MD, PhD

  Niguarda Hospital, Milano, Italy

  PRINCIPAL INVESTIGATOR

• Fabrizio Oliva, MD

  Niguarda Hospital, Milano, Italy

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: October 18, 2017
• Primary Completion: February 27, 2019
• Study Completion: December 31, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)