Clinical trial NCT05836233: Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation
Official title: Predictive Value of Vasodilator Challenge for Right Heart Failure (RHF) After Left Ventricular Assist Device (LVAD) Implantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Right Heart Failure
Keywords: LVAD
Right Heart Failure
Advanced Heart Failure
Nitroprusside
Right Heart Catheterization
Lead sponsor: San Camillo Hospital, Rome
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
First posted: 2023-05-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced heart failure patients undergoing left ventricular assist device implantation in our centers satisfying the inclusion criteria.

All patients presenting one or more of the exclusion criteria will not be included in the study.

Brief 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.

Detailed 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).

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.

Primary outcomes:
measure: Primary Endpoint
timeFrame: 18 months
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: 24 months
measure: Secondary Endpoint
timeFrame: 24 months
measure: Secondary Endpoint
timeFrame: 24 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: San Camillo Hospital
Study officials:
affiliation: San Camillo Hospital
name: Francesco Musumeci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kormos RL, Antonides CFJ, Goldstein DJ, Cowger JA, Starling RC, Kirklin JK, Rame JE, Rosenthal D, Mooney ML, Caliskan K, Messe SR, Teuteberg JJ, Mohacsi P, Slaughter MS, Potapov EV, Rao V, Schima H, Stehlik J, Joseph S, Koenig SC, Pagani FD. Updated definitions of adverse events for trials and registries of mechanical circulatory support: A consensus statement of the mechanical circulatory support academic research consortium. J Heart Lung Transplant. 2020 Aug;39(8):735-750. doi: 10.1016/j.healun.2020.03.010. Epub 2020 Apr 18. No abstract available.