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

Italy200 participantsStarted 2017-10-18

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT03874312

SponsorNiguarda Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-02-27

View on ClinicalTrials.gov More Systolic Chronic Heart Failure trials