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

April 18, 2023 updated by: Giulio Cacioli, San Camillo Hospital, Rome

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.

Other Names:
  • Vasodilator Challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint
Time Frame: 18 months
Early right heart failure
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoint
Time Frame: 24 months
In-hospital all-cause mortality
24 months
Secondary Endpoint
Time Frame: 24 months
1-year all-cause mortality;
24 months
Secondary Endpoint
Time Frame: 24 months
Late right heart failure
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Camillo Hospital, Rome

Collaborators

Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy

Investigators

  • Principal Investigator: Francesco Musumeci, MD, San Camillo Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1235/CE Lazio 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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