The primary objective of the study is to establish the predictive value of the combination of cardiac and extra-cardiac exercise parameters with respect to the response to CRT in CHF patients. Secondary objective is to improve insight in exercise-…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between exercise-related central hemodynamic and extra-cardiac
parameters at baseline and the response to CRT, using logistic regression.
Response to CRT is defined as a decline in end systolic left ventricular volume
of at least 15% and/or increase of left ventricular ejection fraction (LVEF) of
> 5%. Potential central hemodynamic predictors are assessed by exercise
echocardiography (mitral regurgitation, LV volumes and intraventricular
dyssynchrony) and radial artery pulse contour analysis (cardiac output).
Potential extra cardiac predictors include peak oxygen uptake, oxygen uptake
efficiency slope and kinetics of recovery of skeletal muscle oxygenation after
sub maximal exercise using Near Infrared Spectroscopy.
Secondary outcome
None
Background summary
Chronic heart failure (CHF) is an emerging problem in the Western world. In the
last decade it has been shown that implantation of a biventricular
pacemaker/ICD, i.e. Cardiac Resynchronisation Therapy (CRT), can lead to a
substantial improvement of cardiac function, and, as a consequence, to
reduction of morbidity and mortality in this patient category. However, when
applying current selection criteria solely based on resting electrocardiography
and functional status, appr. 40% of all CRT-candidates are non-responders; i.e.
do not show improvement of cardiac function or quality of life (QoL). Despite
extensive research, the cause of non-response is not well understood. Previous
trails unsuccessfully focussed on identification of echocardiographic
parameters at rest as possible predictors of the response to CRT. However,
other studies showed that hemodynamic parameters during exercise are superior
for assessment of severity and prognosis of heart failure. We hypothesize,
supported by several small trials, that central hemodynamic parameters during
exercise are superior for predicting the response to CRT than resting
parameters. Furthermore, extra-cardiac factors (e.g. skeletal muscle blood flow
and metabolism) may also partly be responsible for non-response in certain
patients. By combining exercise measurements of cardiac and skeletal muscle
function during exercise, we believe it is possible to better characterise CHF
patients and thus develop better models for the prediction of the effect of
CRT.
Study objective
The primary objective of the study is to establish the predictive value of the
combination of cardiac and extra-cardiac exercise parameters with respect to
the response to CRT in CHF patients. Secondary objective is to improve insight
in exercise-related physiological effects of CRT in these patients.
Study design
prospective observational cohort study
Study burden and risks
No adverse effects of cycle exercise testing performed by CHF patients, nor for
supine exercise testing during echocardiography have been reported in
literature.. Thresholds of the CRT device for anti tachycardia pacing or
defibrillation will be set substantially (20 beats per minute) above the
maximal heart rate obtained at maximal exercise testing. Testing sessions are
supervised by an experienced physician.
Cardiac output during exercise is evaluated by using a method requiring radial
artery cannulation. This procedure is considered relatively safe with a
complication rate of 0.09% for permanent ischemia of the hand. To ensure
collateral circulation a normal Allen test must be present. Puncture will be
executed under local anaesthesia to minimize patient burden. In patients who
take oral anticoagulation, dosage will be temporarily adjusted (INR < 1.5) for
the safety of the procedure.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
NL
Listed location countries
Age
Inclusion criteria
heart failure NYHA class III
accepted for CRT, according to current guidelines
left ventricular ejection fraction < 35%
Exclusion criteria
Myocardial infarction or unstable angina less than 3 months prior to inclusion
Clinical signs of decompensated heart failure
Ventricular tachycardia or ischemia during exercise
Intra cardiac shunts or congenital heart disease limiting exercise capacity
Orthopaedic, vascular, pulmonary, neuromuscular and other disease limiting exercise capacity in a way that performing exercise tests is not feasible
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49738.015.14 |