Identifying an Ideal Cardiopulmonary Exercise Test Parameter

NCT01162083 | Completed

• 1 other identifier: CRO1570
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Left Ventricular Systolic Dysfunction; Mitral Regurgitation

Keywords

Exercise Physiology; Cardiopulmonary Interaction; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Using Cardiopulmonary Exercise Test Variables to help Assess for Functional Improvement

  6 months

Study Arms (5)

Mitral Valve disease

Patients with mitral valve disease, deemed suitable and ready for elective valve repair or replacement. No significant arrhythmias, other valvular disease or LV dysfunction present. We shall also be recruiting patients undergoing a Mitraclip procedure.

COPD

Patients with isolated chronic obstructive pulmonary disease and no cardiac disease.

Mixed Lesions

Patients with proven limitation from both cardiac and respiratory disease.

CRT

Patients with symptomatic heart failure who have responded to cardiac resynchronisation therapy (biventricular pacemaker).

Cardiomyopathy

Heart Failure of primarily myopathic origin, without rhythm disturbance, ongoing ischaemia or significant valvular disease.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Current patients under tertiary care for cardiac or respiratory disease. Valvular patients will be stable patients under follow-up to judge optimal timing for intervention on clinical grounds at which point they will become applicable to the study.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Recent (recovery within \<1month) decompensation of their underlying cardiac or respiratory disorder.
• Uncontrolled hypertension.

Sponsors & Collaborators

• Imperial College London: lead
• Humboldt-Universität zu Berlin: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W2 1LA, United Kingdom

Location

Related Publications (1)

• Barron A, Francis DP, Mayet J, Ewert R, Obst A, Mason M, Elkin S, Hughes AD, Wensel R. Oxygen Uptake Efficiency Slope and Breathing Reserve, Not Anaerobic Threshold, Discriminate Between Patients With Cardiovascular Disease Over Chronic Obstructive Pulmonary Disease. JACC Heart Fail. 2016 Apr;4(4):252-61. doi: 10.1016/j.jchf.2015.11.003. Epub 2016 Feb 10.

  PMID: 26874378 DERIVED

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Mitral Valve Insufficiency; Heart Failure

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Study Officials

• Roland Wensel, MD PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 14, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 17, 2016

Record last verified: 2011-08

Locations

GB (1)