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| Name | Class |
|---|---|
| Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy | OTHER |
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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.
Inclusion criteria
Exclusion criteria
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enrolled patients - LVAD candidates | Inclusion criteria
Exclusion criteria
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Vasodilators | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | Early right heart failure | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint | In-hospital all-cause mortality | 24 months |
| Secondary Endpoint | 1-year all-cause mortality; | 24 months |
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Inclusion criteria
Exclusion criteria
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giulio Cacioli, MD | Contact | +3906 58704604 | giulio.cacioli@gmail.com | |
| Fabio Sbaraglia, MD | Contact | +3906 58704604 | fsbaraglia@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Musumeci, MD | San Camillo Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Camillo Hospital | Recruiting | Roma | 00152 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32386998 | Result | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Secondary Endpoint | Late right heart failure | 24 months |