Diastolic DysfunctionNCT00765349
Clinical Observational Study Investigating the Role of Diastolic Dysfunction in Determining Abnormal Cardiorespiratory Exercise Testing Parameters in Patients Undergoing Major Surgery
An observational study of Diastolic Dysfunction, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
REASON FOR STUDY Major non-cardiac surgery has a high degree of morbidity and mortality. Recently, suitable measurements of a patient's preoperative cardiorespiratory reserve, performed non-invasively by cardiopulmonary exercise testing, have been shown to be predictive of outcome following non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diastolic Dysfunction
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2008to not given
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients undergoing major elective surgery
Who may be able to join
- Patients undergoing major surgery
- Low functional capacity
Who cannot join
- Unable to give consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
James ' Prentis, MBBS, 01914602958, jamesprentis@btinternet.com
James Prentis, MBBS
About this study
REASON FOR STUDY
Major non-cardiac surgery has a high degree of morbidity and mortality. Recently, suitable measurements of a patient's preoperative cardiorespiratory reserve, performed non-invasively by cardiopulmonary exercise testing, have been shown to be predictive of outcome following non-cardiac surgery. Although the exact mechanisms behind poor reserve in this population are unknown, poor cardiac function and particularly diastolic dysfunction are likely to be important.
Read more
AIMS
The aim of the present study is to investigate the role of diastolic dysfunction in determining poor cardiorespiratory reserve in elderly patients undergoing major non-cardiac surgery. This will provide suitable information to inform a further therapeutic preoperative interventional study.
OBJECTIVES AND METHODS
- To determine the presence and severity of diastolic dysfunction, measured by preoperative transthoracic echocardiogram, in a series of elderly surgical patients undergoing major elective non-cardiac surgery
- To investigate the relationship between diastolic dysfunction and poor cardiorespiratory function during and following exercise measured by non-invasive testing including cardiopulmonary exercise testing, non-invasive blood pressure measurements and biochemical analysis
- To determine whether patients with poor diastolic dysfunction are likely to have worse outcomes following major surgery compared with those who show no evidence of diastolic dysfunction. Outcomes will be measured in terms of length of hospital stay and early postoperative morbidity (validated scoring system) and mortality.
- Conditions
- Diastolic Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients undergoing major surgery | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startMay 2008
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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765349
- Sponsor's protocol ID
- 08/H0902/11
- Status last verified
- Oct 2015
- First submitted
- 1 Oct 2008
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observational Study Investigating the Role of Diastolic Dysfunction in Determining Abnormal Cardiorespiratory Exercise Testing Parameters in Patients Undergoing Major Surgery
- ClinicalTrials.gov ID
- NCT00765349
- Acronym / sponsor ID
- 08/H0902/11
- Conditions
- Diastolic Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- May 2008
- First posted
- 2 Oct 2008 (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.
REASON FOR STUDY
Major non-cardiac surgery has a high degree of morbidity and mortality. Recently, suitable measurements of a patient's preoperative cardiorespiratory reserve, performed non-invasively by cardiopulmonary exercise testing, have been shown to be predictive of outcome following non-cardiac surgery. Although the exact mechanisms behind poor reserve in this population are unknown, poor cardiac function and particularly diastolic dysfunction are likely to be important.
AIMS
The aim of the present study is to investigate the role of diastolic dysfunction in determining poor cardiorespiratory reserve in elderly patients undergoing major non-cardiac surgery. This will provide suitable information to inform a further therapeutic preoperative interventional study.
OBJECTIVES AND METHODS
- To determine the presence and severity of diastolic dysfunction, measured by preoperative transthoracic echocardiogram, in a series of elderly surgical patients undergoing major elective non-cardiac surgery
- To investigate the relationship between diastolic dysfunction and poor cardiorespiratory function during and following exercise measured by non-invasive testing including cardiopulmonary exercise testing, non-invasive blood pressure measurements and biochemical analysis
- To determine whether patients with poor diastolic dysfunction are likely to have worse outcomes following major surgery compared with those who show no evidence of diastolic dysfunction. Outcomes will be measured in terms of length of hospital stay and early postoperative morbidity (validated scoring system) and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients undergoing major surgery | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients undergoing major elective surgery
Key inclusion criteria (2 listed)
- Patients undergoing major surgery
- Low functional capacity
Key exclusion criteria (1 listed)
- Unable to give consent
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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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.
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 Diastolic Dysfunction, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
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 12 Oct 2015. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact james prentis, mbbs (0191 4602958, jamesprentis@btinternet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 12 Oct 2015.