Status:
COMPLETED
Identifying an Ideal Cardiopulmonary Exercise Test Parameter
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Humboldt-Universität zu Berlin
British Heart Foundation
Conditions:
Left Ventricular Systolic Dysfunction
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
Heart failure, where the heart muscle is damaged and is unable to pump blood efficiently, affects 9% of those aged 55 or more and is responsible for about 2% of the hospital admissions in the UK. The ...
Eligibility Criteria
Inclusion
- Aged over 18 years of age.
- Able to perform cycle ergometry and agree to perform between 2 and 3 tests.
- If previously undergone echocardiography there is evidence of reasonable echo windows (good views).
- Agree to the full study protocol.
Exclusion
- 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
- 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).
- Anaemia (Hb \<12 in men, \<11 in women).
- Obesity (BMI \>30) which could lead to limitation independent of the cardiovascular or respiratory condition.
- 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.
- Poor echocardiographic windows so that a full data set is not achievable.
- Inability to perform a symptom limited cardiopulmonary exercise test.
- Inability to perform spirometry.
- Inability to consent/make decisions (lack of competence)
- Vulnerable adult/current detainee in prison/elsewhere.
- Significant neurological or musculoskeletal abnormalities.
- Inability to complete all the investigations at the time intervals agreed in the protocol.
- 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).
- 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.
- Recent (recovery within \<1month) decompensation of their underlying cardiac or respiratory disorder.
- Uncontrolled hypertension.
- Untreated life threatening arrhythmia.
- Recent surgery (within 10 weeks).
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01162083
Start Date
October 1 2010
End Date
May 1 2013
Last Update
February 17 2016
Active Locations (1)
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1
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1LA