Evaluating the predictive value of a vasodilator challenge for right heart failure after LVAD implantation
Predictive Value of Vasodilator Challenge for Right Heart Failure (RHF) After Left Ventricular Assist Device (LVAD) Implantation
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | San Camillo Hospital, Rome Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT05836233 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with advanced heart failure requiring LVAD implantation and specific hemodynamic parameters.
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.
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 performed: While similar studies have explored hemodynamic assessments in heart failure, this specific approach using a vasodilator challenge is relatively novel.
Eligibility criteria
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 this trial is running
Roma
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.