Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation
Launched by SAN CAMILLO HOSPITAL, ROME · Apr 18, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating how a special test called a "vasodilator challenge" can help predict the risk of right heart failure after patients receive a Left Ventricular Assist Device (LVAD). An LVAD is a mechanical pump used to support patients with severe heart failure. In this study, participants will receive an infusion of a medication called sodium nitroprusside to see how their heart responds. Researchers will then analyze the data to better understand which factors are linked to developing right heart failure after getting an LVAD.
To be eligible for this trial, participants must be at least 18 years old and have advanced heart failure that requires an LVAD. They should also meet specific blood pressure criteria to ensure their safety during the test. Unfortunately, individuals who are pregnant or unable to undergo the vasodilator challenge, as well as those who require other heart support devices, cannot participate. For those who join the study, they can expect close monitoring during the vasodilator challenge, and their information will help improve care for future patients undergoing this procedure.
Gender
ALL
Eligibility 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.
About San Camillo Hospital, Rome
San Camillo Hospital in Rome is a renowned healthcare institution committed to advancing medical research and improving patient care through innovative clinical trials. With a focus on a wide range of therapeutic areas, the hospital leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous and ethically sound studies. San Camillo Hospital collaborates with leading researchers and healthcare professionals to ensure the highest standards of clinical practice, fostering a patient-centered approach that prioritizes safety and efficacy. Through its dedication to scientific excellence and community health, San Camillo Hospital plays a pivotal role in the evolution of modern medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
Patients applied
Trial Officials
Francesco Musumeci, MD
Principal Investigator
San Camillo Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported