Incidence, Impact and Mechanisms of Perioperative Right VEntricular Dysfunction (IMPRoVE)

Right Ventricular Dysfunction Clinical Trial

— IMPRoVE  

Official title:

Incidence, Impact and Mechanisms of Perioperative Right VEntricular Dysfunction (IMPRoVE)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05827315
• Other study ID #: 22/ANAES/06
• Status: Not yet recruiting
• Start date: April 2023
• Est. completion date: April 2026

Study information

• Verified date: April 2023
• Source: NHS National Waiting Times Centre Board
• Contact: Ben Shelley
• Phone: 0141 951 5000
• Email: Benjamin.Shelley[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A study to see how common right heart failure (right ventricular dysfunction) after major surgery is, and to investigate if right ventricular dysfunction causes worse patient outcomes after surgery.

Description:

Heart attacks are relatively rare around the time of surgery, however by measuring blood markers of heart injury, recent research has revealed that heart injury which otherwise may not be immediately obvious is common. Whilst this type of heart injury appears to be strongly linked to patient outcomes (complications, recovery and survival), the causes and potential treatments for it are not well understood. Our research group has specialist knowledge about the right-hand side of the heart (right-heart) - the side that pumps blood through the lungs - which is less commonly considered or studied around the time of surgery. We have shown in previous studies using magnetic resonance imaging (MRI) scans (specialised whole-body scans which use a magnet rather than X-rays), evidence of right-heart function deteriorating after surgery. We want to test the idea that some of the blood marker evidence of heart injury reflects injury to the right-heart and more importantly that we can protect the right-heart around the time of surgery, reducing injury and improving patient outcomes. We will examine these questions in the following ways: 1. With patients' permission, we will perform detailed ultrasound scans of the heart (echocardiography), and blood measurement of injury markers in 175 patients undergoing different types of major surgery. This will allow us to assess how common heart injury is (visible on scans of both sides of the heart), whether it makes any difference to a patient's outcome and whether it explains the changes seen in blood markers. 2. We will ask 50 of these patients to undergo MRI scans of the heart pre- and post-operatively to allow us to identify evidence of injury resulting from heart inflammation around the time of surgery. Inflammation is common following surgery and occurs throughout a patient's body - we believe heart inflammation may be responsible for postoperative heart injury. 3. In 10 of these patients, we will seek to obtain blood samples from vessels flowing into the heart (easily obtained from a simple blood sample) and from veins flowing out of the heart, obtained by passing a fine tube into the heart via blood vessels in a patient's neck under X-ray guidance. This will allow us to examine what happens to immune cells as they pass through the heart (i.e., are they activated by heart inflammation?) and better understand the meaning of the changes seen on MRI scans. This study will give us a better understanding of which patients are likely to suffer heart injury around the time of surgery and how this injury occurs. With this knowledge, future patients could receive personalised treatment plans aimed at preventing injury and improving outcomes. We are not testing any new treatments in this study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 175
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main echocardiography study

Inclusion Criteria:

1. Provision of informed consent

2. Age >18 years

3. Planned elective primary hip or knee joint replacement under spinal anaesthesia, major colorectal, major vascular surgery or surgery requiring one lung ventilation with or without lung resection

Exclusion Criteria:

1. Pregnancy

2. On-going participation in any investigational research which could undermine the scientific basis of the study

3. Previous major surgery within three months prior to recruitment

4. Previous participation in the IMPRoVE study at any time

5. Inadequate comprehension of English resulting in inability to comply with instructions while undergoing investigations required for main study and sub-studies.

Additional exclusion criteria applicable to the T1 CMR sub-study includes:

1. Atrial fibrillation at baseline

2. Contraindication to cardiac magnetic resonance imaging (metal work in body etc)

3. Contraindication to IV Gadolinium: acute or chronic renal failure, allergy to contrast

Related Conditions & MeSH terms

• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Diagnostic Test:
• Echocardiography
Echocardiography will be performed by BSE accredited echocardiographers in all 175 patients preoperatively and on day 2-4 postoperatively.
• T1 Cardiovascular Magnetic Resonance
T1 CMR will be performed in 10 patients from each of the 5 surgical groups (50 patients in total) preoperatively and on day 2-4 postoperatively.
• Right heart catheterisation and coronary sinus blood sampling
10 patients from the thoracic surgical group will undergo right heart catheterisation and coronary sinus blood sampling.

Locations

Country	Name	City	State
United Kingdom	Golden Jubilee National Hospital	Clydebank
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Queen Elizabeth University Hospital	Glasgow

Sponsors (4)

Lead Sponsor	Collaborator
NHS National Waiting Times Centre Board	NHS Greater Glasgow and Clyde, Royal London Hospital, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative Right ventricular dysfunction (RVD)	RVD diagnosed by transthoracic echocardiography, defined as: 2D-speckle tracking derived RV free wall peak longitudinal strain (FWLS) less negative than -20%.; Or, (where not available) two of Tricuspid Annular Plane Systolic Excursion (TAPSE) <16mm, S' Wave velocity at the tricuspid annulus <10cm/s or tissue doppler RV index of myocardial performance >0.55	Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in RV function
Primary	Days alive and at home at 30 days postoperatively (DAH30)	DAH30 is a continuous number between 0 and 30 which reflects, out of the 30 days following surgery, the total number of those days that a patient spends alive and at home. If a patient dies within those 30 days, their value is set to 0. Data for DAH30 will be obtained by follow-up phone calls following the 30th postoperative day.	Day 30 postoperatively
Secondary	Incidence of postoperative left ventricular dysfunction (LVD)	LVD classified as mild, moderately or severely impaired, defined by 2D-echocardiography derived biplane LV ejection fraction and the presence of wall motion abnormalities.	Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in LV function
Secondary	Cardiac biomarkers	Natriuretic peptides and high sensitivity troponin will be measured pre- and postoperatively.	BNP and troponin measured preoperatively, on postoperative days 1 and 2 and on day of postoperative echocardiography (occurring on postoperative days 2-4).
Secondary	Cardiovascular complications	Incidence of myocardial infarction, cardiac death, non-fatal cardiac arrest, coronary revascularisation, pulmonary embolus, deep-veined thrombosis, or new onset atrial fibrillation, and major adverse cardiac events	Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Secondary	Renal outcomes	Kidney Disease Improving Global Outcome (KDIGO) classification of Acute Kidney Injury (AKI).	Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Secondary	Pulmonary outcomes	Atelectasis, pneumonia, acute respiratory distress syndrome or pulmonary aspiration	Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Secondary	Infection Outcomes	Fever and clinical suspicion of infection	Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Secondary	Neurological outcomes	Delirium and stroke	Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Secondary	Sequential Organ Failure Assessment (SOFA) Score	Score 0-24, where higher scores are a worse outcome.	Postoperative day 1,2, day of postoperative echocardiography in all patients. In patients admitted to HDU/ICU, SOFA score will be collected from postoperative day 0-7.
Secondary	Fifteen-point Quality of Recovery Score (QoR-15)	Fifteen questions assessing the quality of a patients recovery, each question is scored 0-10 with higher scores indicating a worse outcome.	Pre-operatively and day of postoperative echocardiography (day 2-4 postoperatively).
Secondary	World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)	WHODAS 2.0 is a self administered questionnaire that assesses a patient's health and disability. Twelve questions are scored 0-4, where a higher score indicates a worse outcome.	Preoperatively, and at day 30, day 90, and one year postoperatively.
Secondary	EuroQoL Dimension Health Related Quality of Life Questionnaire (EQ-5D-5L)	EQ-5D-5L is a self administered questionnaire that assesses 5 dimensions of a patient's quality of life. Each dimension is scored 1-5, where a higher score indicates a worse outcome.	Preoperatively, and at day 30, day 90, and one year postoperatively.