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Clinical Observational Study Investigating the Role of Diastolic Dysfunction in Determining Abnormal Cardiorespiratory Exercise Testing Parameters in Patients Undergoing Major Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00765349
Recruitment Status : Unknown
Verified October 2015 by Newcastle-upon-Tyne Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : October 2, 2008
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Brief Summary:


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.


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.


  1. 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
  2. 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
  3. 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.

Condition or disease
Diastolic Dysfunction

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2008

All patients undergoing major surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing major elective surgery

Inclusion Criteria:

  • Patients undergoing major surgery
  • Low functional capacity

Exclusion Criteria:

  • Unable to give consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00765349

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Contact: james prentis, mbbs 0191 4602958
Contact: chris snowden, mbbs 01912336161 ext 31306

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United Kingdom
Freeman Hospital Recruiting
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Contact: James ` Prentis, MBBS    01914602958   
Principal Investigator: James Prentis, MBBS         
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust Identifier: NCT00765349    
Other Study ID Numbers: 08/H0902/11
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015