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

Right Heart Failure Clinical Trial

— PREVV-RHF-LVAD  

Official title:

Predictive Value of Vasodilator Challenge for Right Heart Failure (RHF) After Left Ventricular Assist Device (LVAD) Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05836233
• Other study ID #: 1235/CE Lazio 1
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2023
• Source: San Camillo Hospital, Rome
• Contact: Giulio Cacioli, MD
• Phone: +3906 58704604
• Email: giulio.cacioli[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Right Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Italy	San Camillo Hospital	Roma

Sponsors (2)

Lead Sponsor	Collaborator
San Camillo Hospital, Rome	Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 defin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint	Early right heart failure	18 months
Secondary	Secondary Endpoint	In-hospital all-cause mortality	24 months
Secondary	Secondary Endpoint	1-year all-cause mortality;	24 months
Secondary	Secondary Endpoint	Late right heart failure	24 months