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Search / Trial NCT05836233

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

Lvad Right Heart Failure Advanced Heart Failure Nitroprusside Right Heart Catheterization

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.

Locations

Roma, , Italy

Patients applied

0 patients applied

Trial Officials

Francesco Musumeci, MD

Principal Investigator

San Camillo Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported