An observational study in Right Ventricular Dysfunction, sponsored by Fondazione Policlinico Universitario Campus Bio-Medico. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Fondazione Policlinico Universitario Campus Bio-Medico · Observational
Right ventricular dysfunction (RVD) is common following cardiac surgery, and it is characterised by impaired right ventricular function that can lead to decreased cardiac output and hemodynamic instability. RVD is consistently associated with poor outcomes.
The mechanisms behind RVD post-surgery involve changes in preload, after load, and RV contraction. Factors linked to higher incidence of postoperative RVD include decreased tricuspid annular plane excursion (TAPSE), elevated preoperative pulmonary artery pressure, lung diseases, duration of extracorporeal circulation, and left valve surgery.
While predictive scores for RVD exist for left ventricular assist device (LVAD) patients, no such models are available for other cardiac surgeries. Identifying specific predictors could lead to models that identify high-risk patients, allowing for tailored monitoring and treatment strategies.
The primary aim of this study is to create a preoperative risk score for predicting the development of right ventricular dysfunction following adult cardiac surgery through a retrospective analysis on patients who underwent heart surgery.
Postoperative RVD will be defined as:
- Echocardiographic parameters suggestive of RVD (at least 2 out of 3): TAPSE \< 16 mmHg; right ventricular fractional area change (RVFAC) \< 35%; right ventricular end systolic dilation > 3,5 cm (measured from the septum to the free wall).
AND
- Need for inotropic and/or pulmonary vasodilator drug support and/or mechanical support.
Data will be collected retrospectively on: demographic characteristics; basic patient characteristics (weight, height, Body Mass Index -BMI, etc.); preoperative pharmacological therapy; preoperative comorbidities; abnormalities in blood tests; chest X-rays and ECGs; abnormalities in coronary angiography and carotid ultrasound; preoperative echocardiographic examination: TAPSE, Left Ventricular Ejection Fraction- LVEF, valvular pathologies, Pulmonary Artery Systolic Pressure- PAPs, pericardial effusion; type of surgical intervention; occlusion of the posterior interventricular coronary artery (acute or chronic); duration of the surgical procedure; duration of extracorporeal circulation; non-revascularized right coronary artery disease; blood product transfusions; postoperative pharmacological therapy (with particular regard to the use of inotropes/pulmonary vasodilators/vasopressors); postoperative echocardiographic examination: TAPSE; RVFAC; right ventricular dilation at end-systole; postoperative complications; Intensive Care Unit (ICU) length of stay and hospital length of stay.
90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.
This study's enrollment of 1,000 is above the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.
Browse Ventricular Dysfunction, Right studies →Fondazione Policlinico Universitario Campus Bio-Medico is the lead sponsor of 29 studies on the registry; 20 are open to participants now.
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Adult patients who underwent cardiac surgery between January 2016 and December 2023 at the Policlinico Fondazione Campus BioMedico.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creation of a preoperative risk score for predicting the development of right ventricular dysfunction after adult cardiac surgery.
Preoperative patient characteristics (demographic features, BMI, preoperative conditions, etc.) and surgical factors (type of procedure, duration of cardiopulmonary bypass, duration of surgery, etc.) will be correlated with the development of RVD in the early postoperative period. Scores will be assigned to factors showing significant correlation. The sum of these scores will yield the total score and thus the risk level. Unabbreviated score title: The RightScore Minimum/maximum values: Depending on the number of risk factors associated with right ventricular dysfunction. Higher scores indicate worse outcomes.
Time frame: September 2024 - December 2025
Retrospective validation of the created score (The RightScore) on adult cardiac surgery patients operated at Policlinico Fondazione Campus Bio-Medico between January 2016 and December 2023.
The RightScore will be calculated using retrospectively analyzed data for every adult patient operated on at Policlinico Fondazione Campus Bio-Medico between January 2016 and December 2023. Preoperative and intraoperative data will be used to predict postoperative right ventricular dysfunction. This prediction will be correlated with the actual development of postoperative right ventricular dysfunction to retrospectively validate the score created. Unabbreviated score title: The RightScore Minimum/maximum values: Depending on the number of risk factors associated with right ventricular dysfunction. Higher scores indicate worse outcomes.
Time frame: September 2024 - December 2025
Correlation between postoperative RVD and postoperative outcomes.
Correlation with mortality, stroke, multi-organ dysfunction, re-intubation, cardiac arrest, increased length of stay in the ICU, increased hospital stay.
Time frame: September 2024 - December 2025
Sub-analysis of the risk score.
Sub-analysis of the risk score for the subtype of surgery performed by the patient. Unabbreviated score title: The RightScore Minimum/maximum values: Depending on the number of risk factors associated with right ventricular dysfunction. Higher scores indicate worse outcomes.
Time frame: September 2024 - December 2025
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Campus Bio-Medico