Mitral Regurgitation Clinical Trial
— PVAOfficial title:
Identifying the Ideal Parameter of the Cardiopulmonary Exercise Test to Distinguish Between the Cardiovascular and Respiratory Components of Functional Limitation and to Detect Relevant Physiological Changes in Function
Verified date | August 2011 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Department of Health |
Study type | Observational |
Cardiopulmonary exercise testing (CPET) is a safe, noninvasive investigation where a patient
walks on a treadmill or cycles whilst attached to an ECG and with a mask that measures the
air breathed in and out. It has numerous clinical uses, such as diagnosing the main cause in
patients with breathlessness, deciding on timing for heart transplantation and assessing
whether patients are safe for a general anaesthetic.
A patient's peak oxygen consumption, the maximum amount of oxygen taken up by the blood from
the lungs when breathing increases during exercise, is the main measurement taken from CPET.
It is low in heart disease and has been used to predict the risk of death and therefore plan
treatments for patients. However this is also low in numerous other diseases including lung
disease; reduced oxygen consumption in patients with two conditions may be wrongly thought
to be because of the heart leading to inappropriate action and distress to the patient.
Newer measurements of exercise capacity from the same exercise test are better at predicting
death in heart failure.
We propose that they are more specific for heart failure over other diseases, for example
lung disease, when compared with peak oxygen consumption, and are superior when a single
best test for heart failure is required.
This research aims to identify which measurement of exercise capacity is most specific for
heart failure. We will perform the test on many patients with different diseases, and before
and after procedures such as the implantation of special pacemakers, and heart valve
operations. This should lead to a more accepted use of this investigation and the more
appropriate identification of which patient should have which procedure.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Aged over 18 years of age. 2. Able to perform cycle ergometry and agree to perform between 2 and 3 tests. 3. If previously undergone echocardiography there is evidence of reasonable echo windows (good views). 4. Agree to the full study protocol. Exclusion Criteria: 1. Significant coexistent pathologies of the groups tested unless specifically in that group of mixed pathologies in the "Observational Study". This includes any combination of COPD or restrictive lung disease alongside heart failure and valvular disease. Therefore all cardiac conditions should have no significant limitation on spirometry, and all patients with lung disease should have good left ventricular function with no significant increases in pulmonary vascular pressures as seen on echocardiography. Patients with atrial fibrillation/ flutter will be excluded. Patients with more than mild valvular lesions will be excluded from all groups except the joint group and the group with mitral valvular disease 2. Symptomatic coronary disease, or significant ischaemia noted on cardiopulmonary exercise test (unless accounted for by aortic valve disease, in which case a prior coronary angiogram would have been undertaken if significant coronary disease then they will not be invited to participate). 3. Anaemia (Hb <12 in men, <11 in women). 4. Obesity (BMI >30) which could lead to limitation independent of the cardiovascular or respiratory condition. 5. Chronic Kidney Disease Stage 3 or above (estimated GFR <60ml/hr as calculated by Cockcroft Gault equation). The metabolic acidosis associated with this condition will affect ventilatory equivalents. 6. Poor echocardiographic windows so that a full data set is not achievable. 7. Inability to perform a symptom limited cardiopulmonary exercise test. 8. Inability to perform spirometry. 9. Inability to consent/make decisions (lack of competence) 10. Vulnerable adult/current detainee in prison/elsewhere. 11. Significant neurological or musculoskeletal abnormalities. 12. Inability to complete all the investigations at the time intervals agreed in the protocol. 13. Permanent Pacemaker unless in the biventricular pacemaker group in the Interventional Study. These patients in this group will be excluded if they are pacing dependent (when the biventricular function is disabled they do not have a normal intrinsic rhythm) and if they have significant first degree AV block at rest or on exercise (will activate right ventricular pacing after a sinus beat). 14. Patients in the atrial fibrillation interventional group will be excluded if they revert back to atrial fibrillation after the procedure, or the procedure never restores sinus rhythm. These patients will still be eligible for inclusion in the observational study. 15. Recent (recovery within <1month) decompensation of their underlying cardiac or respiratory disorder. 16. Uncontrolled hypertension. 17. Untreated life threatening arrhythmia. 18. Recent surgery (within 10 weeks). |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College Healthcare NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | British Heart Foundation, Humboldt-Universität zu Berlin |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The relation or change between Cardiopulmonary exercise test variables | In the Observational Cohort Study the primary outcome measure is the relation between variables (peak VO2, VE/VCO2, OUES, Tau, AT) when compared between the groups with different disease states. In the Interventional Cohort Study the primary outcome is the change in a variable (peak VO2, VE/VCO2, OUES, Tau, AT) from before to after an intervention which is required on clinical grounds. |
Up to 6 months | No |
Secondary | Using Cardiopulmonary Exercise Test Variables to help Assess for Functional Improvement | In patients undergoing heart valve replacements or an ablation for atrial fibrillation the improvement in symptomatic benefit will be compared to the change in cardiopulmonary exercise test variables. | 6 months | No |
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