Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation (NCT05836233) | Clinical Trial Compass
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Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation
Italy150 participantsStarted 2023-02-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.