* To establish the feasibility (i.e. % of measurements with sufficient quality for analysis) of exercise echocardiography in CHF patients, focusing on left ventricular function (LVEF), myocardial tissue motion (intra- and interventricular…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility (i.e. % of measurements with sufficient quality for analysis) of
the following exercise echocardiography variables:
- LVEF
- Intraventricular dyssynchrony (peak systolic longitudinal strain)
- Interventricular dyssynchrony (Inter Ventricular Mechanical Delay)
- Mitral regurgitation (regurgitant volume)
Day-to-day reproducibility of these exercise echocardiography variables (Blant
Altman analysis)
Secondary outcome
NA
Background summary
In recent years several studies have shown that exercise echocardiography has
potentially added clinical value as compared to resting echocardiography as a
tool for the evaluation of patient with chronic heart failure (CHF). Potential
clinical applications that have arisen include grading of the severity of
valvular disease (mitral regurgitation), assessment of prognosis, and
prediction and assessment of the effects of cardiac resynchronization therapy
in CHF patients. Currently, however, exercise echocardiography is poorly
implemented in daily clinical practice.
Although several studies showed good intra- and interobserver variability of
exercise echocardiography variables in selected populations of CHF patients,
data on its feasibility are lacking. Moreover, no data exist on the
reproducibility of potentially relevant exercise echocardiography variables
such as left ventricular ejection fraction (LVEF), the severity of mitral
regurgitation and myocardial tissue motion.
Study objective
* To establish the feasibility (i.e. % of measurements with sufficient quality
for analysis) of exercise echocardiography in CHF patients, focusing on left
ventricular function (LVEF), myocardial tissue motion (intra- and
interventricular dyssynchrony) and the severity of mitral regurgitation.
* To determine the day-to-day reproducibility of these variables
Study design
The study is designed as a prospective observational study, including stable
patients with stable CHF. Patients are requested to visit the hospitals 3
times. During the first visit patients undergo a routine clinical examination,
followed by an incremental symptom limited exercise test with respiratory gas
analysis . During the second and third visit (after 7 days and 9-14 days
respectively) echocardiography is performed on an echocardiography stress
table in a left lateral supine position. Measurements are performed at rest and
subsequently during exercise using four 2-minute exercise bouts, respectively
at 30%, 60% and 90% of the ventilatory threshold, and halfway between the
ventilatory threshold and peak VO2. Images are stored for off line analysis by
an experienced cardiologist blinded for the patient number and test order.
Study burden and risks
There are no direct benefits for individual participants other than additional
information / insight into their disease based on the results of the exercise
tests. On a population level, the results of this study may contribute to a
wider implementation of exercise echocardiography which may improve the
clinical assessment and therapy selection in CHF patients. No adverse effects
of cycle exercise testing performed by CHF patients, nor for supine exercise
testing during echocardiography have been reported in literature. Testing
sessions are supervised by an experienced physician.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
NL
Listed location countries
Age
Inclusion criteria
- Systolic heart failure due to ischemic cardiomyopathy or dilating cardiomyopathy
- Left ventricular ejection fraction * 40%
Exclusion criteria
- Myocardial infarction or unstable angina less than 3 months prior to
inclusion
- Clinical signs of decompensated heart failure
- Documented 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
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 | NL44300.015.13 |