Abdominal Aortic Aneurysm Patients Under Surveillance Clinical Trial
Official title:
The Influence of Beta-blockade on Cardiopulmonary Function Measured by Cardiopulmonary Exercise Testing
A major determinant of perioperative mortality is the inability of the heart to increase its
output in response to surgical stress. This is termed perioperative cardiac failure (PCF),
and may only be apparent postoperatively when oxygen demand is increased. The risk of
perioperative cardiac complications is the summation of the individual patient's risk and
cardiac stress related to the surgical procedure1. The functional capacity of the patient
determines their ability to support the postoperative demand of increased oxygen
consumption, and therefore of cardiac output. Exercise capacity is one of the most powerful
predictors of cardiovascular and all cause mortality2. Cardiopulmonary exercise test (CPET)
is an established investigation used, among other applications, in the preoperative
assessment of patient fitness for surgery3. CPET involves monitoring the
electrocardiographic trace and the exhaled gas mixture (particularly CO2, whose production
depends on aerobic metabolism), during incremental exercise (usually on an exercise bike),
on room air. Several parameters can be measured during CPET, including maximal systemic
oxygen delivery, the anaerobic threshold (the oxygen delivery value at which anaerobic
metabolism begins), maximum workload, and ST segment depression/elevation (as in a standard
exercise tolerance test). The cardiopulmonary "performance" during CPET has been correlated
with postoperative outcome3. Pulmonary function tests will be performed in order to assess
lung function.
It is well known that therapy with beta-blockers in patients with ischaemic heart disease
and cardiac failure reduces perioperative morbidity and mortality4-7. However, beta blockers
reduce myocardial contractility and the heart rate response to adrenergic stimulation, thus
blunting the physiological response to stress/surgery/exercise. Whilst this mechanism may
protect the heart perioperatively, it may decrease the ability of some patients to withstand
other complications. This potential decrease in "performance" has never been quantified.
There is no agreement on whether preoperative CPET should be performed on or off
beta-blockers and, at Aintree in particular, it is standard procedure to take patients off
beta-blockers prior to their CPET. Some argue that, as beta-blockade should be maintained in
the perioperative period, CPET should be performed on medications, even if these could mask
the presence significant ischaemic heart disease (a significant, modifiable, risk factor for
surgery by beta blockade), and even if it is not always possible to maintain beta-blockade
throughout the whole postoperative period. For these reasons, other clinicians prefer to
perform CPET off beta-blockers, thus, potentially, overestimating the perioperative
cardiorespiratory "performance", which may be diminished once the medications are resumed.
Patients on long-term beta blockade may develop some tolerance to the medications, so the
effect of acute and chronic beta blockade on cardiorespiratory performance may also be
different.
Aim To compare cardiopulmonary performances on and off beta blockers as objectively assessed
by cardiopulmonary exercise testing.
| Status | Completed |
| Enrollment | 55 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. >18 years of age inclusive, undergoing major surgery who are already on therapy with beta blockers 2. >18 years of age, undergoing major surgery who are not on beta blockers 3. Patient able to consent to study protocol 4. Ability to perform CPET on an exercise bike 5. AAA patients under surveillance. Exclusion Criteria: 1. Known contraindication to bisoprolol (known intolerance, asthma or history of bronchospasm, II or III degree heart block, treatment with verapamil or ivrabadine, sinus bradycardia, Prinzmetal`s angina), 2. Severe ischaemic heart disease (including acute coronary syndrome within 3 months of recruitment), 3. Inability to use an exercise bike 4. Stage IV and V chronic kidney disease 5. Uncontrolled hypertension 6. Patients withholding informed consent 7. Patients unable to give informed consent due to mental incapacity 8. Patients who find uncomfortable and anxiety provoking performing an exercise test 9. Patients who present contraindications (relative/absolute) to their first initial CPET based on the American Thoracic Society (ATS) exercise testing guidelines. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Aintree University Hospitals | Liverpool |
| Lead Sponsor | Collaborator |
|---|---|
| Michelle Mossa |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in oxygen uptake | Baseline and 72hours post beta-blockade | No |