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Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation

NCT05836233 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-05-01

No results posted yet for this study

Summary

Prospective evaluation of the predictive value for post-LVAD right ventricular failure (RHF) of pulmonary vasodilator challenge, in addition to current laboratory, echocardiographic and haemodynamic parameters.

LVAD candidates satisfying the inclusion criteria will undergo vasodilator challenge with sodium nitroprusside (NTP) infusion following the study protocol.

Thereafter, we will evaluate all data in order to determine which variables significantly correlate with RHF onset after LVAD implantation.

Conditions

  • Right Heart Failure

Interventions

DRUG

Pulmonary Vasodilators

Right heart catheterization via Swan Ganz catether will be performed under optimal medical therapy within 90 days before LVAD implantation. We will record the timing between RHC and LVAD implantation. Vasodilator challenge will be performed through intravenous nitroprusside administration and titration (by 5 minutes intervals) until symptoms (flushing or hypotension) onset or systolic systemic pressure drop below 85 mmHg (target dose). Dobutamine or phosphodiesterase inhibitors infusion could be performed at clinician's discretion. All haemodynamic measurements will be repeated after nitroprusside infusion and titration until the target dose.

Sponsors & Collaborators

  • Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy

    collaborator OTHER

  • San Camillo Hospital, Rome

    lead OTHER

Principal Investigators

  • Francesco Musumeci, MD · San Camillo Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2025-01-01
Completion
2025-08-01
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05836233 on ClinicalTrials.gov