Primary objectives are 1) pulmonary function in stable CHF, 2) COPD prevalence, under- and overdiagnosis in stable CHF patients, 3) systemic inflammation in stable CHF: is there a synergistic effect when COPD coexists? Secondary objectives are 1)…
ID
Source
Brief title
Condition
- Other condition
- Heart failures
- Bronchial disorders (excl neoplasms)
Synonym
Health condition
systemische inflammatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters/outcome of the study: 1) Lung function abnormalities
in stable CHF, 2) COPD prevalence, under- and overdiagnosis, 3) systemic
inflammation (hs-CRP, leukocytes, platelets, fibrinogen, TNF-a, IL-6).
Secondary outcome
Secondary study parameters/outcome of the study: 1) Predictors of COPD in CHF,
2) systemic inflammation after conventional COPD treatment: hs-CRP, leukocytes,
platelets, fibrinogen, TNF-a, IL-6, 3) association between inflammatory markers
and various patient characteristics, 4) lung function abnormalities after
conventional COPD treatment, 5) Quality of life and dyspnoea before and after
conventional COPD treatment.
Background summary
There is only a small body of literature addressing pulmonary function in
patients with stable chronic heart failure (CHF), although pulmonary
abnormalities associated with CHF may explain part of the symptom and
functional disability encountered in this group of patients. COPD frequently
coexists with CHF and it has an adverse prognostic impact as well as diagnostic
and therapeutic implications. Despite this, accurate and precise data on the
prevalence of COPD in stable CHF are still lacking and COPD remains to be
widely undiagnosed. Finally, although both COPD and CHF show increased systemic
inflammation when studied separately, it is not known whether there is a
synergistic effect when both conditions coexist.
Study objective
Primary objectives are 1) pulmonary function in stable CHF, 2) COPD prevalence,
under- and overdiagnosis in stable CHF patients, 3) systemic inflammation in
stable CHF: is there a synergistic effect when COPD coexists? Secondary
objectives are 1) independent predictors of COPD in stable CHF, 2) association
between inflammatory markers and various patient characteristics and 3) the
effect of conventional COPD treatment on systemic inflammatory markers,
pulmonary function, quality of life and dyspnoea.
Study design
This is a cross-sectional study.
Study burden and risks
Subjects will undergo the following examinations: 2 laboratory tests (at
baseline and one month later), a chest X-ray, pulmonary function tests
(spirometry with reversibility test, body plethysmography and diffusion for
carbon monoxide with single breath method) and measurement of BMI. They will
also complete the MLHFQ and MRC dyspnoea and Borg scale. COPD de novo patients
who will receive conventional treatment will repeat laboratory test, pulmonary
function tests and same questionnaires 3 months after treatment. Patients with
a lung function indicative of COPD GOLD III will additionally undergo arterial
blood gas sampling to determine whether they belong to COPD GOLD IV in case of
chronic respiratory failure. Participants can have their first blood sample
taken after their visit to the HF nurse or cardiologist, so this will not
require an extra visit to the hospital. The second blood sample and chest X-ray
will take place one month later. Within the next 2 days the patient will get
to know by way of a telephone call whether he or she can be included in the
study. Additional questions (hospitalization, diuretics change, weight gain,
change in NYHA class) to determine whether the subject meets the inclusion
criteria will be asked during this telephone call. When included, the
participant will be scheduled to meet the investigator and undergo all the
investigations on very short term. COPD de novo patients will be followed-up
three months later and thereafter if necessary. The burden of the study is
mainly the time that the patients have to invest. The laboratory tests can
cause haematomas. Some side-effects of the short acting bronchodilator
salbutamol, used routinely to assess reversibility of lung function, have been
reported. However these are usually mild and temporary in nature. The direct
benefit of the study is the finding and treating of otherwise unknown COPD and
gaining better insight regarding the interaction between COPD en CHF.
Wagnerlaan 55
6815 AD, Arnhem
Nederland
Wagnerlaan 55
6815 AD, Arnhem
Nederland
Listed location countries
Age
Inclusion criteria
·Stable chronic heart failure patients with left ventricular systolic dysfunction (LVEF < 40%) and/or diastolic dysfunction (E/E* > 15 and LVEF > 50%)
·Outpatients
·NYHA class I-IV
·18 years and older
·Informed consent
Exclusion criteria
·Patients who do not meet the inclusion criteria
·Patients who are not able to cooperate or undergo pulmonary function tests
·Other diseases that can lead to obstructive lung function: asthma, cystic fibrosis
·Disorders/diseases that can lead to restrictive lung function:
oPulmonary: lung surgery (lobectomy/pneumectomy), parenchymal neoplasms, interstitial lung disease, sarcoidosis, pneumoconioses, lung abscess, lobar pneumonia, post-infectious scarring, atelectasis, radiation fibrosis
oPleural: diffuse pleural thickening, mesothelioma, pleural effusion, pneumothorax
oNeuromuscular diseases: ALS, poliomyelitis, myopathy, bilateral diaphragmatic paralysis, high spinal cord lesions, myasthenia gravis
oAbdominal: obesity (BMI > 35)
oPericardial: major pericardial effusion
oLarge mediastinal processes
oCollagenvascular diseases
·Malignancy with bad prognosis (survival < 6 months)
·Patients with active infection or inflammatory disease such as rheumatoid arthritis
·Patients who are already participating in another study within the cardiological department
Design
Recruitment
Medical products/devices used
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 | NL27798.091.09 |