The primary objective is to establish the point prevalence of Airflow Limitation (AL) compatible with COPD in patients with congestive heart failure (CHF) seen in a single centre in the Netherlands.
ID
Source
Brief title
Condition
- Heart failures
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Airflow limitation (AL), defined as FEV1/FVC < 0.70 (post bronchodilator)
Secondary outcome
* Severity of AL, as defined by GOLD stages;
* Restrictive AL, defined by FEV1/FVC *0.70 and a predicted FVC <80% (post
bronchodilator)
* AL as defined by FEV1 below the lower limit of normal (LLN), as measured by
standardized spirometry equipment;
* Diffusion capacity for carbon monoxide, using the single breath method.
* Presence of past history of airflow limitation or COPD;
* Health status questionnaire scores (mMRC dyspnoea score; Kansas City
Cardiomyopathy Questionnaire, SF-12, and COPD Assessment Test (CAT));
* Healthcare utilisation: Number of emergency room visits and hospital
admissions in previous 12 months.
Background summary
Dyspnoea is a common symptom, particularly in elderly patients, but it is not
specific for a single disease. The most common diseases causing dyspnoea are
heart failure (HF) and COPD. Usually, the clinical focus is posed either on
heart failure or COPD, but due to the common risk factors, i.e. age and
smoking, many patients are suffering from both diseases. However, the
co-existence of the two diseases is often missed or treatment commented without
proper diagnostics, which is why patients are often not optimally treated.
Therefore, we aim to overcome this clinically important shortcoming by
investigating consecutive patients diagnosed with and treated for heart failure
with respect to the prevalence of airflow limitation and the clinical
consequences thereof. Moreover, we aim to identify patients at risk for airflow
limitation to significantly improve identification of these patients and, as a
consequence, to improve care
Study objective
The primary objective is to establish the point prevalence of Airflow
Limitation (AL) compatible with COPD in patients with congestive heart failure
(CHF) seen in a single centre in the Netherlands.
Study design
cross-sectional, observational cohort study.
Study burden and risks
This is a mere observational study without any intervention. The information
gathering will be based on lung function testing and short questionnaires,
which is the main burden for the patients. Moreover, blood samples will be
taken. Lung function testing and blood sampling will be performed by trained
study personnel. The length of the questionnaires will be kept to a minimum.
Quantitative data on patient*s characteristics will be largely taken from the
already existing patient*s charts. Thus, there are no additional examinations
necessary due to the study.
Overall, there is no major risk for individual patients in participating in
this study. The potential benefit is related to the possible detection of
unrecognised limitation in lung function, which may be then therapeutically
addressed. This may help to reduce the burden of the patients related to
dyspnoea
P debeijelaan 25
6229HX Maastricht
NL
P debeijelaan 25
6229HX Maastricht
NL
Listed location countries
Age
Inclusion criteria
documented HeartFailure based on left ventricular dysfunction (irrespective of ejection fraction) (following current ESC guidelines)
age patients 50 years or older
Exclusion criteria
Patients for whom spiromerty is contra indicated
patients with recent surgery, myocardial infarction or cardiac decompensation, lower respiratory tract infection or stroke
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 | NL39223.068.12 |