Right Ventricular DysfunctionThe RightScoreNCT06539000
Preoperative Risk Score for Postoperative Right Ventricular Dysfunction in Adult Cardiac Surgery
An observational study of Right Ventricular Dysfunction, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Dysfunction
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 31 Dec 2025
- 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
- Adult, Older adult
Study population: Adult patients who underwent cardiac surgery between January 2016 and December 2023 at the Policlinico Fondazione Campus BioMedico.
Who may be able to join
- age > 18 years
- elective or urgent cardiac surgery at Campus BioMedico between January 2016 to December 2023
- postoperative echocardiogram execution
- ASA class I-IV
Who cannot join
- age < 18 years
- inotropic therapy at the time of surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Lazio, 00128
About this study
Official title: The "RIGHT-SCORE" Study: a Preoperative Risk Score for Postoperative Right Ventricular Dysfunction in Adult Cardiac Surgery
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Right Ventricular Dysfunction
- Medical subject headings
- Ventricular Dysfunction, Right
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: September 2024 - December 2025
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: September 2024 - December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Oct 2024
- Primary completion31 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Right Ventricular DysfunctionStudies 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
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Strumia, MD, Fondazione Policlinico Universitario Campus Bio-Medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539000
- Sponsor's protocol ID
- The RightScore
- Acronym
- The RightScore
- Status last verified
- Jan 2026
- First submitted
- 21 Jul 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mattei A, Strumia A, Benedetto M, Nenna A, Schiavoni L, Barbato R, Mastroianni C, Giacinto O, Lusini M, Chello M, Carassiti M. Perioperative Right Ventricular Dysfunction and Abnormalities of the Tricuspid Valve Apparatus in Patients Undergoing Cardiac Surgery. J Clin Med. 2023 Nov 17;12(22):7152. doi: 10.3390/jcm12227152.
PubMed 38002763Varma PK, Jose RL, Krishna N, Srimurugan B, Valooran GJ, Jayant A. Perioperative right ventricular function and dysfunction in adult cardiac surgery-focused review (part 1-anatomy, pathophysiology, and diagnosis). Indian J Thorac Cardiovasc Surg. 2022 Jan;38(1):45-57. doi: 10.1007/s12055-021-01240-y. Epub 2021 Oct 27.
PubMed 34898875Estrada VH, Franco DL, Moreno AA, Gambasica JA, Nunez CC. Postoperative Right Ventricular Failure in Cardiac Surgery. Cardiol Res. 2016 Dec;7(6):185-195. doi: 10.14740/cr500e. Epub 2016 Dec 31.
PubMed 28197291Kaul TK, Fields BL. Postoperative acute refractory right ventricular failure: incidence, pathogenesis, management and prognosis. Cardiovasc Surg. 2000 Jan;8(1):1-9. doi: 10.1177/096721090000800101.
PubMed 10661697Matthews JC, Koelling TM, Pagani FD, Aaronson KD. The right ventricular failure risk score a pre-operative tool for assessing the risk of right ventricular failure in left ventricular assist device candidates. J Am Coll Cardiol. 2008 Jun 3;51(22):2163-72. doi: 10.1016/j.jacc.2008.03.009.
PubMed 18510965
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "RIGHT-SCORE" Study: a Preoperative Risk Score for Postoperative Right Ventricular Dysfunction in Adult Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06539000
- Acronym / sponsor ID
- The RightScore / The RightScore
- Conditions
- Right Ventricular Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Aug 2024 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent cardiac surgery between January 2016 and December 2023 at the Policlinico Fondazione Campus BioMedico.
Key inclusion criteria (4 listed)
- age > 18 years
- elective or urgent cardiac surgery at Campus BioMedico between January 2016 to December 2023
- postoperative echocardiogram execution
- ASA class I-IV
Key exclusion criteria (2 listed)
- age < 18 years
- inotropic therapy at the time of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Creation of a preoperative risk score for predicting the development of right ventricular dysfunction after adult cardiac surgery.
Time frame: September 2024 - December 2025
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.
3 secondary outcomes
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.
Time frame: September 2024 - December 2025
Correlation between postoperative RVD and postoperative outcomes.
Time frame: September 2024 - December 2025
Sub-analysis of the risk score.
Time frame: September 2024 - December 2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Background: PubMed 38002763Mattei A, Strumia A, Benedetto M, Nenna A, Schiavoni L, Barbato R, Mastroianni C, Giacinto O, Lusini M, Chello M, Carassiti M. Perioperative Right Ventricular Dysfunction and Abnormalities of the Tricuspid Valve Apparatus in Patients Undergoing Cardiac Surgery. J Clin Med. 2023 Nov 17;12(22):7152. doi: 10.3390/jcm12227152.
- Background: PubMed 34898875Varma PK, Jose RL, Krishna N, Srimurugan B, Valooran GJ, Jayant A. Perioperative right ventricular function and dysfunction in adult cardiac surgery-focused review (part 1-anatomy, pathophysiology, and diagnosis). Indian J Thorac Cardiovasc Surg. 2022 Jan;38(1):45-57. doi: 10.1007/s12055-021-01240-y. Epub 2021 Oct 27.
- Background: PubMed 28197291Estrada VH, Franco DL, Moreno AA, Gambasica JA, Nunez CC. Postoperative Right Ventricular Failure in Cardiac Surgery. Cardiol Res. 2016 Dec;7(6):185-195. doi: 10.14740/cr500e. Epub 2016 Dec 31.
- Background: PubMed 10661697Kaul TK, Fields BL. Postoperative acute refractory right ventricular failure: incidence, pathogenesis, management and prognosis. Cardiovasc Surg. 2000 Jan;8(1):1-9. doi: 10.1177/096721090000800101.
- Background: PubMed 18510965Matthews JC, Koelling TM, Pagani FD, Aaronson KD. The right ventricular failure risk score a pre-operative tool for assessing the risk of right ventricular failure in left ventricular assist device candidates. J Am Coll Cardiol. 2008 Jun 3;51(22):2163-72. doi: 10.1016/j.jacc.2008.03.009.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ventricular Dysfunction, run by Fondazione Policlinico Universitario Campus Bio-Medico 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 2 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: finished, as of the sponsor's last update on 6 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a preoperative risk score for predicting the development of right ventricular dysfunction after adult cardiac surgery. (time frame: September 2024 - December 2025). 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 NCT06539000, which also lists 5 linked publications.
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 6 Jan 2026.