Diastolic DysfunctionNCT02285309
Perioperative Measurements of Diastolic Function in Cardiac Surgery
An observational study of Diastolic Dysfunction, run by University College, London.
Trial summary
This observational clinical trial will investigate the following perioperative indices relating to cardiac surgery: 1. The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diastolic Dysfunction
- What is being tested?
- Cardiac Surgery and enoximone
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jul 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Any cardiac surgery
Who may be able to join
- Systolic dysfunction (EF <50%) or diastolic dysfunction grade 1-3 as determined through preoperative TTE or intraoperative TOE
- Able to give informed consent
Who cannot join
- Contraindication to transoesphageal echocardiography (such as previous oesophagectomy)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Utility of Novel Measurements of Diastolic Function Involving Transoesophageal and Transthoracic Echocardiography in the Peri-operative Period in Patients Undergoing Cardiac Surgery -an Exploratory Trial
This observational clinical trial will investigate the following perioperative indices relating to cardiac surgery:
- The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures.
- The significance of measurements involving right heart relaxation function and itrs relation to outcome measures.
- The influence of drugs such as enoximone on these outcome measures.
Read the detailed description
Over the past two decades, perioperative TOE has become routine part of monitoring in the setting of cardiac surgery. In many centres around the world nearly 100% of pateints undergoing cardiac surgery are monitored using this modality. There are several studies and observational reviews suggesting intraoperative TOE can change management and thus indirectly influence outcome in patients undergoing valve, aortic or bypass graft surgery. Certainly in our centre at The Heart Hospital, it is routine practce to perform an intraoperative TOE in all patients undergoing cardiac surgery in order to guide surgical and anaesthetic management of the patient. Despite this use of TOE there is very little evidence of how TOE influences patient related outcomes, both morbidity and mortality.
Several advances have occurred over the years involving both better technology to image the heart with TOE along with the development of novel measurements of heart function. As technology has evolved, many modalities and measurement have not been validated in the setting of cardiac surgery. In our observational clincal trial we aim to investigate the following:
- The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures.
- The significance of measurements involving the right heart relaxation function and itrs relation to outcome measures.
- The influence of drugs such as enoximone on these outcome measures.
While many of these measurements have been validated in the care of medical patients, they have not been examined in the surgical setting. In addition, its ability to predict outcome has never been tested. We believe this study will help us answer these important questions.
- Conditions
- Diastolic Dysfunction
- Being tested
- Cardiac Surgery and enoximone
- Keywords
- Cardiac Surgery, Diastolic Dysfunction, Enoximone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Surgery and enoximoneProcedure or surgery
Does diastolic function change with cardiac surgery +/- enoximone
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery | Not described Receives: Procedure: Cardiac Surgery and enoximone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diastolic dysfunction -categorised as improved, stable or worse
Compare diastolic dysfunction before and after surgery in those that receive enoximone. Compare diastolic function before and after surgery in those that do not receive enoximone
Measured: Up to 12 hours
Secondary outcomes (7)
Systolic and diastolic data from the post operative transthoracic echocardiogram
Compare systolic and diastolic function on transthoracic echocardiography to intraoperative parameters
Measured: Up to 30 days
Duration of endotracheal intubation (in hours)
How long patient remains intubated on ICU post operatively
Measured: 0-30 days
Incidence of post operative atrial fibrillation
As above
Measured: 0-30 days
Duration of ICU stay
As above
Measured: 0-30 days
Duration of hospital stay
As above
Measured: 0-30 days
Cardiac Post Operatie Morbidity Score (C-POMS)
As above
Measured: 0-30 days
30 day Major Adverse Cardiovascular Events
As above
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285309
- Sponsor's protocol ID
- UCLondon
- Status last verified
- Nov 2014
- First submitted
- 4 Nov 2014
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Novel Measurements of Diastolic Function Involving Transoesophageal and Transthoracic Echocardiography in the Peri-operative Period in Patients Undergoing Cardiac Surgery -an Exploratory Trial
- ClinicalTrials.gov ID
- NCT02285309
- Acronym / sponsor ID
- UCLondon
- Conditions
- Diastolic Dysfunction
- Keywords
- Cardiac Surgery, Diastolic Dysfunction, Enoximone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 6 Nov 2014 (estimated)
- 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.
This observational clinical trial will investigate the following perioperative indices relating to cardiac surgery:
- The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures.
- The significance of measurements involving right heart relaxation function and itrs relation to outcome measures.
- The influence of drugs such as enoximone on these outcome measures.
Detailed description
Over the past two decades, perioperative TOE has become routine part of monitoring in the setting of cardiac surgery. In many centres around the world nearly 100% of pateints undergoing cardiac surgery are monitored using this modality. There are several studies and observational reviews suggesting intraoperative TOE can change management and thus indirectly influence outcome in patients undergoing valve, aortic or bypass graft surgery. Certainly in our centre at The Heart Hospital, it is routine practce to perform an intraoperative TOE in all patients undergoing cardiac surgery in order to guide surgical and anaesthetic management of the patient. Despite this use of TOE there is very little evidence of how TOE influences patient related outcomes, both morbidity and mortality.
Several advances have occurred over the years involving both better technology to image the heart with TOE along with the development of novel measurements of heart function. As technology has evolved, many modalities and measurement have not been validated in the setting of cardiac surgery. In our observational clincal trial we aim to investigate the following:
- The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures.
- The significance of measurements involving the right heart relaxation function and itrs relation to outcome measures.
- The influence of drugs such as enoximone on these outcome measures.
While many of these measurements have been validated in the care of medical patients, they have not been examined in the surgical setting. In addition, its ability to predict outcome has never been tested. We believe this study will help us answer these important questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery | – | Procedure: Cardiac Surgery and enoximone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any cardiac surgery
Key inclusion criteria (2 listed)
- Systolic dysfunction (EF <50%) or diastolic dysfunction grade 1-3 as determined through preoperative TTE or intraoperative TOE
- Able to give informed consent
Key exclusion criteria (1 listed)
- Contraindication to transoesphageal echocardiography (such as previous oesophagectomy)
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 |
|---|---|---|
| Cardiac Surgery and enoximoneDoes diastolic function change with cardiac surgery +/- enoximone | Procedure or surgery | Cardiac surgery |
Primary outcome
Change in diastolic dysfunction -categorised as improved, stable or worse
Time frame: Up to 12 hours
Compare diastolic dysfunction before and after surgery in those that receive enoximone. Compare diastolic function before and after surgery in those that do not receive enoximone
7 secondary outcomes
Systolic and diastolic data from the post operative transthoracic echocardiogram
Time frame: Up to 30 days
Duration of endotracheal intubation (in hours)
Time frame: 0-30 days
Incidence of post operative atrial fibrillation
Time frame: 0-30 days
Duration of ICU stay
Time frame: 0-30 days
Duration of hospital stay
Time frame: 0-30 days
Cardiac Post Operatie Morbidity Score (C-POMS)
Time frame: 0-30 days
30 day Major Adverse Cardiovascular Events
Time frame: 0-30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diastolic Dysfunction, run by University College, London.
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 1 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 6 Nov 2014. 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 Bonnie Kyle (02034567898, bonniekyle@doctors.net.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diastolic dysfunction -categorised as improved, stable or worse (time frame: Up to 12 hours). 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 6 Nov 2014.