Right Ventricular DysfunctionRIVERNCT04167241
Right Ventricle Function After Major Right Lung Resection
An observational study of Right Ventricular Dysfunction and Pneumonectomy; Status, run by Humanitas Clinical and Research Center.
Trial summary
Major lung resection is associated with high post-operative morbidity and mortality and significant long-term decreased functional capacity, especially due to cardiorespiratory complications. RV (Right Ventricle) ejection, pulmonary artery pressure and tone are tightly coupled. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Right Ventricular Dysfunction, Pneumonectomy; Status
- What is being tested?
- Echocardiography
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 8 Nov 2019to 30 Nov 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients submitted to right pneumonectomy or bi-lobectomy
Who may be able to join
- Adults patients undergoing right pneumonectomy
- Adults patients undergoing pulmonary bilobectomy
Who cannot join
- Left pneumonectomy (it will not permit TTE postoperatively)
- Completion pneumonectomy
- Patients suffering from any myocardial disease
- Preceding Pulmonary Embolism
- Pregnancy
- Potential pregnancy
- Patients enrolled into another trial
Trial locations and contacts
No sites are listed yet.
Antonio Messina contact
About this study
Official title: Early Peri-operative Right Ventricle Dysfunction Following Major Lung Resection
Major lung resection is associated with high post-operative morbidity and mortality and significant long-term decreased functional capacity, especially due to cardiorespiratory complications.
RV (Right Ventricle) ejection, pulmonary artery pressure and tone are tightly coupled. The RV is exquisitely sensitive to changes in afterload. When pulmonary vascular reserve is compromised RV ejection may be also compromised, increasing right atrial pressure and limiting maximal cardiac output. Acute increase in RV outflow resistance, as may occur with acute pulmonary embolism will cause acute RV dilatation and, by ventricular interdependence, markedly decreased LV (Left Ventricle) compliance, rapidly spiraling to acute cardiogenic shock and death.
Most of the studies on RV function after lung resection are small and have found different results, and sometimes conflicting findings. As far as the investigators know, there are no data on the incidence of the RV dysfunction after major lung resection (pneumonectomy/bilobectomy) and it's not clear if there is some direct association between the RV dysfunction and post-operative complications. If so, early detection of RV dysfunction after major lung resection could provide the opportunity for interventional therapy with consequent possible improvement of these patients' prognosis.
Read the detailed description
The aim of this study is to identify the incidence of early RV systolic dysfunction (defined as Tricuspid Annular Plane Systolic Excursion (TAPSE) < 17 cm, S' (TDI) < 10 cm/s) and estimate the RV-PA (Right Ventricle-Pulmonary Artery) coupling as indicated by Guazzi et all. (TAPSE/PAPs ratio, where PAPs is the Systolic Pulmonary Artery Pressure) after major lung resection (bilobectomy and pneumonectomy) using echocardiography, and to assess if these modifications (RV dysfunction and RV-PA coupling) may be associated with post-operative cardiopulmonary complications occurring during the hospitalization period. Investigators also intend to evaluate if these changes are associated with impaired functional capacity at 3 months after surgery.
- Being tested
- Echocardiography
- Keywords
- Right Ventricle Disfunction, Pneumonectomy, Echocardiography
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Before and after right pneumonectomy or bi-lobectomy patients will receive echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Patients submitted to right pneumonectomy or bi-lobectomy | Consecutive, elective surgical patients submitted to right pneumonectomy or bi-lobectomy Receives: Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of right ventricle disfunction
Incidence of early RV systolic dysfunction (defined as TAPSE < 17 mm, S' (TDI) < 10 cm/s) and estimate the RV-PA coupling as indicated by Guazzi et al. (TAPSE/PAPs ratio mm/mmHg) after major lung resection (bilobectomy and pneumonectomy) using echocardiography.
Measured: Immediately after the awakening from general anesthesia (Day 0)
Secondary outcomes (3)
Post-operative outcome
Pulmonary failure may be associated with post-operative pulmonary embolism
Measured: Within 3rd post-operative day
Right ventricle failure
RV dysfunction and RV-PA uncoupling may be associated with post-operative pulmonary hypertension occurring during the hospitalization period.
Measured: Within 3rd post-operative day
Post-operative quality of life
DASI questionnaire
Measured: 3 months, post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start8 Nov 2019 (estimated)
- Primary completion7 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Giustiniano, Humanitas Clinical and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167241
- Sponsor's protocol ID
- RIVER Trial
- Acronym
- RIVER
- Status last verified
- Nov 2019
- First submitted
- 8 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Peri-operative Right Ventricle Dysfunction Following Major Lung Resection
- ClinicalTrials.gov ID
- NCT04167241
- Acronym / sponsor ID
- RIVER / RIVER Trial
- Keywords
- Right Ventricle Disfunction, Pneumonectomy, Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 8 Nov 2019 (estimated)
- Primary completion
- 7 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 18 Nov 2019 (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.
Major lung resection is associated with high post-operative morbidity and mortality and significant long-term decreased functional capacity, especially due to cardiorespiratory complications.
RV (Right Ventricle) ejection, pulmonary artery pressure and tone are tightly coupled. The RV is exquisitely sensitive to changes in afterload. When pulmonary vascular reserve is compromised RV ejection may be also compromised, increasing right atrial pressure and limiting maximal cardiac output. Acute increase in RV outflow resistance, as may occur with acute pulmonary embolism will cause acute RV dilatation and, by ventricular interdependence, markedly decreased LV (Left Ventricle) compliance, rapidly spiraling to acute cardiogenic shock and death.
Most of the studies on RV function after lung resection are small and have found different results, and sometimes conflicting findings. As far as the investigators know, there are no data on the incidence of the RV dysfunction after major lung resection (pneumonectomy/bilobectomy) and it's not clear if there is some direct association between the RV dysfunction and post-operative complications. If so, early detection of RV dysfunction after major lung resection could provide the opportunity for interventional therapy with consequent possible improvement of these patients' prognosis.
Detailed description
The aim of this study is to identify the incidence of early RV systolic dysfunction (defined as Tricuspid Annular Plane Systolic Excursion (TAPSE) < 17 cm, S' (TDI) < 10 cm/s) and estimate the RV-PA (Right Ventricle-Pulmonary Artery) coupling as indicated by Guazzi et all. (TAPSE/PAPs ratio, where PAPs is the Systolic Pulmonary Artery Pressure) after major lung resection (bilobectomy and pneumonectomy) using echocardiography, and to assess if these modifications (RV dysfunction and RV-PA coupling) may be associated with post-operative cardiopulmonary complications occurring during the hospitalization period. Investigators also intend to evaluate if these changes are associated with impaired functional capacity at 3 months after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients submitted to right pneumonectomy or bi-lobectomy | – | Diagnostic Test: EchocardiographyConsecutive, elective surgical patients submitted to right pneumonectomy or bi-lobectomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients submitted to right pneumonectomy or bi-lobectomy
Key inclusion criteria (2 listed)
- Adults patients undergoing right pneumonectomy
- Adults patients undergoing pulmonary bilobectomy
Key exclusion criteria (7 listed)
- Left pneumonectomy (it will not permit TTE postoperatively)
- Completion pneumonectomy
- Patients suffering from any myocardial disease
- Preceding Pulmonary Embolism
- Pregnancy
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 |
|---|---|---|
| EchocardiographyBefore and after right pneumonectomy or bi-lobectomy patients will receive echocardiography | Diagnostic test | Patients submitted to right pneumonectomy or bi-lobectomy |
Primary outcome
Prevalence of right ventricle disfunction
Time frame: Immediately after the awakening from general anesthesia (Day 0)
Incidence of early RV systolic dysfunction (defined as TAPSE < 17 mm, S' (TDI) < 10 cm/s) and estimate the RV-PA coupling as indicated by Guazzi et al. (TAPSE/PAPs ratio mm/mmHg) after major lung resection (bilobectomy and pneumonectomy) using echocardiography.
3 secondary outcomes
Post-operative outcome
Time frame: Within 3rd post-operative day
Right ventricle failure
Time frame: Within 3rd post-operative day
Post-operative quality of life
Time frame: 3 months, post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- 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.
Antonio Messina contact
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Dysfunction and Pneumonectomy; Status, run by Humanitas Clinical and Research Center.
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 2 inclusion and 7 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Enrico Giustiniano, MD (+390282247459, enrico.giustiniano@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of right ventricle disfunction (time frame: Immediately after the awakening from general anesthesia (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2019.