Right Heart FailurePREVV-RHF-LVADNCT05836233
Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation
An observational study of Right Heart Failure, run by San Camillo Hospital, Rome at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Heart Failure
- What is being tested?
- Pulmonary Vasodilators
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2023to 1 Aug 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Camillo Hospital
Roma, 00152
Giulio Cacioli, MD, +390658704604, giulio.cacioli@gmail.com
Fabio Sbaraglia, MD, +390658704604, fsbaraglia@gmail.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Right Heart Failure
- Being tested
- Pulmonary Vasodilators
- Keywords
- LVAD, Right Heart Failure, Advanced Heart Failure, Nitroprusside, Right Heart Catheterization
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary VasodilatorsDrug
Also called Vasodilator Challenge
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pulmonary Vasodilators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
Early right heart failure
Measured: 18 months
Secondary outcomes (3)
Secondary Endpoint
In-hospital all-cause mortality
Measured: 24 months
Secondary Endpoint
1-year all-cause mortality;
Measured: 24 months
Secondary Endpoint
Late right heart failure
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start15 Feb 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Right Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- San Camillo Hospital, Rome
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
- Responsible party
- Principal investigator, Giulio Cacioli, San Camillo Hospital, Rome
- Investigators
- Francesco Musumeci, MD, Principal investigator, San Camillo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836233
- Sponsor's protocol ID
- 1235/CE Lazio 1
- Acronym
- PREVV-RHF-LVAD
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32386998
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Vasodilator Challenge for Right Heart Failure (RHF) After Left Ventricular Assist Device (LVAD) Implantation
- ClinicalTrials.gov ID
- NCT05836233
- Acronym / sponsor ID
- PREVV-RHF-LVAD / 1235/CE Lazio 1
- Conditions
- Right Heart Failure
- Keywords
- LVAD, Right Heart Failure, Advanced Heart Failure, Nitroprusside, Right Heart Catheterization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- San Camillo Hospital, RomeUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled patients - LVAD candidates | – | Drug: Pulmonary VasodilatorsInclusion 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary VasodilatorsAlso: Vasodilator ChallengeRight 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. | Drug | Enrolled patients - LVAD candidates |
Primary outcome
Primary Endpoint
Time frame: 18 months
Early right heart failure
3 secondary outcomes
Secondary Endpoint
Time frame: 24 months
Secondary Endpoint
Time frame: 24 months
Secondary Endpoint
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Results publication: PubMed 32386998Kormos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Musumeci, MD principal investigator
San Camillo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Heart Failure, run by San Camillo Hospital, Rome at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulio Cacioli, MD (+3906 58704604, giulio.cacioli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05836233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.