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

NCT05836233 | Unknown FDA Drug

• 1 other identifier: 1235/CE Lazio 1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Right Heart Failure

Keywords

LVAD; Right Heart Failure; Advanced Heart Failure; Nitroprusside; Right Heart Catheterization

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  Early right heart failure

  18 months

Secondary Outcomes (3)

• Secondary Endpoint

  24 months

• Secondary Endpoint

  24 months

• Secondary Endpoint

  24 months

Study Arms (1)

Enrolled patients - LVAD candidates

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.

Drug: Pulmonary Vasodilators

Interventions

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.

Also known as: Vasodilator Challenge

Enrolled patients - LVAD candidates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Camillo Hospital, Rome: lead
• Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy: collaborator

Study Sites (1)

San Camillo Hospital

Roma, 00152, Italy

RECRUITING

Related 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 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.

  PMID: 32386998 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Francesco Musumeci, MD

  San Camillo Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulio Cacioli, MD

CONTACT

+3906 58704604; giulio.cacioli@gmail.com

Fabio Sbaraglia, MD

CONTACT

+3906 58704604; fsbaraglia@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 1, 2023
• Study Start: February 15, 2023
• Primary Completion: January 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)