Predictive Value of Vasodilator Challenge for Right Heart Failure After

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. Right heart catheterization (RHC) RHC will be performed under optimal medical therapy within 90 days before 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 drops below 85 mmHg. Dobutamine or phosphodiesterase inhibitors infusion could be performed at clinician's discretion. All haemodynamic measurements will be repeated after nitroprusside infusion and titration. Right heart failure (RHF) Post-operative RHF will be evaluated according to the definition proposed by the 2020 consensus statement of the mechanical circulatory support academic research consortium (1). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05836233
Study type	Observational [Patient Registry]
Source	San Camillo Hospital, Rome
Contact	Giulio Cacioli, MD
Phone	+3906 58704604
Email	giulio.cacioli@gmail.com
Status	Recruiting
Phase
Start date	February 15, 2023
Completion date	August 1, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation — PREVV-RHF-LVAD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms