The primary aim of this observational study is to determine the occurrence of exercise-induced left ventricular diastolic dysfunction (LV-DD) in symptomatic COPD patients with a normal echocardiography at rest. And, secondly, to study the…
ID
Source
Brief title
Condition
- Heart failures
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
•Exercise-induced LV-DD; defined by E/E* > 15 during stress echocardiography.
Secondary outcome
•Baseline spirometry and diffusion capacity
•Inspiratory capacity, as measuer of dynamic hyperinflation
•CPET parameters: peak-V*O2,, V*E/V*CO2 and O2-pulse
•Systemic inflammation: IL-18, IL-6 and hs-CRP
•All other cardio-pulmonary exercise test parameters.
•Sub-maximal exercise (6-MWD with Borg scores).
•Daily life physical activity measured by SenseWear pro armband.
•Metabolic and muscular status (BMI and Fat-free Mass).
•Peripheral muscle strength measured by Jamar dynamometer.
•Other markers of systemic inflammation (TNF-α, and fibrinogen, IL-8, Monocyte
chemoatractant protein 1 (MCP-1))
•Markers of collagen metabolism in serum (carboxyterminal propeptide of
collagen 1 (PICP), aminoterminal propeptide of collagen (PINP),
amino-terminal propeptide of collagen 3 (PIIINP) and carboxy-terminal
telopeptide of collagen 1 (CITP)
•Matrix metalloproteinases (MMP) 2 and 9 and tissue inhibitor of MMP*s in serum
(TIMP1). MMP9/TIMP1 ratio as predictor of left atrial volume index.
•Endothelial function measured by forearm mediated vasodilatation (FMD)
•Biomarkers of (left and right) ventricular strain: NT-proBNP, troponine-T.
•Other stress-induced echocardiographic parameters: sPAP and Pv-acceleration
time, E/A and deceleration time, E/E*, Ard-Ad, Left atrial volume index (LAVI),
left ventricular mass index (LVMI)) to determine LV-DD
Background summary
The presence of left ventricle diastolic dysfunction (LV-DD), as assessed by
echocardiography, can be observed at rest in more severely affected COPD
patients; it has a negative impact on exercise tolerance, and may have
important prognostic and potentially also therapeutic implications.
Exercise-induced LV-DD is likely to precede LV-DD at rest, and may contribute
to the exercise limitation which can be observed in these patients.
Study objective
The primary aim of this observational study is to determine the occurrence of
exercise-induced left ventricular diastolic dysfunction (LV-DD) in symptomatic
COPD patients with a normal echocardiography at rest. And, secondly, to study
the relationship of exercise-induced LV-DD with baseline clinical
characteristics, exercise-induced (dynamic) hyperinflation, CPET parameters and
systemic inflammation.
Study design
Observational study
Study burden and risks
Patients included in the study participate in investigations as part of routine
clinical practice. As part of the study, an additional visit to the hospital
for echocardiography during exercise is necessary. Before and after exercise
venous blood samples will be taken once according to study protocol. The risks
and physical discomforts of the investigations are to the same extend as
described for exercise testing as part of routine clinical practice.
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
Inclusion criteria
- COPD patients classified according to the GOLD staging system and the criteria of the BODE index
- Informed consent
- > 18 years of age
- Male and female
- Patients able to perform a cycling test
Exclusion criteria
- Age <= 18 years of age
- Pregnancy
- Patients not able to perform a cycling test
- Patients with clinical evidence of significant cardiovascular disease (including coronary artery disease, history of myocardial infarcation, significant valvular disease, cardiomyopathy, arterial hypertension, echocardiographic presence of left ventricular systolic dysfunction)
- Patients with atrial fibrillation.
- Patients on cardiac medication (ACE inhibitors, beta-blockers, AT-II antagonists, Calcium channel blockers)
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 |
|---|---|
| Other | NL 40084.100.12 |
| CCMO | NL40084.100.12 |