Evaluating the predictive value of a vasodilator challenge for right heart failure after LVAD implantation
Official title: Predictive Value of Vasodilator Challenge for Right Heart Failure (RHF) After Left Ventricular Assist Device (LVAD) Implantation
Run by San Camillo Hospital, Rome · NCT05836233 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if a special medication can help doctors predict which patients with advanced heart failure might develop right heart failure after getting a left ventricular assist device (LVAD).
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | San Camillo Hospital, Rome Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT05836233 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with advanced heart failure requiring LVAD implantation and specific hemodynamic parameters.
✕Probably not a fit
Patients who are pregnant, unable to undergo the vasodilator challenge, or require immediate right ventricular support will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the predictive value of a pulmonary vasodilator challenge using sodium nitroprusside in patients with advanced heart failure who are candidates for left ventricular assist device (LVAD) implantation. Participants will undergo right heart catheterization and the vasodilator challenge to measure various hemodynamic parameters. The goal is to identify which variables correlate significantly with the onset of right heart failure after LVAD surgery. Data collected will help improve patient selection and management strategies post-implantation.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict right heart failure in patients after LVAD implantation, potentially improving patient outcomes.
How similar studies have gone: While similar studies have explored hemodynamic assessments in heart failure, this specific approach using a vasodilator challenge is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria * Age over 18 years old. * Diagnosis of advanced heart failure with an indication for LVAD implantation. * Mean Arterial Pressure (MAP) \> 60 mmHg; Mean Pulmonary Arterial Pressure (mPAP) \> 20 mmHg; Pulmonary Artery Wedge Pressure \>15 mmHg. * Vasodilator Challenge performed through NTP infusion. Exclusion criteria * State of pregnancy. * Inability to perform vasodilator challenge * Need for extracorporeal membrane oxygenator or short-term right ventricular assist devices. * Planned right ventricular assist device implantation in the peri-procedural setting.
Where it's running
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San Camillo Hospital
Roma, Italy Recruiting
Study contacts
- Principal investigator: Francesco Musumeci, MD — San Camillo Hospital
- Study coordinator: Giulio Cacioli, MD
- Email: giulio.cacioli@gmail.com
- Phone: +3906 58704604
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This trial tests whether the CorVad percutaneous ventricular assist device can be safely used to help patients with stubborn right heart failure when medicines and support devices aren’t enough.
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This study is testing if adding two different medications to standard care can help people with right heart failure and pulmonary hypertension feel better and if it's possible to do a bigger study in the future.
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This study is testing if the medication valsartan can help adults with pulmonary arterial hypertension feel better and improve their heart function.
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Understanding the HeartMate 3 device and its impact on patients
This study looks at how the HeartMate 3 device affects patients with advanced heart failure by checking for problems like bleeding and infection, while also seeing how it impacts their quality of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.