1) Pulmonary function in stable chronic heart failure (CHF). 2) COPD prevalence, underdiagnosis and overdiagnosis in stable CHF patients and its independent predictors. 3) Systemic inflammation in COPD and stable CHF: is there a synergistic effect?

Completed

• Conditions: systemische inflammatie; chronic bronchitis/emphysema; COPD; 10019280; 10006436

• Registration Number: NL-OMON33134
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 369

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters/outcome of the study: 1) Lung function abnormalities<br /><br>in stable CHF, 2) COPD prevalence, under- and overdiagnosis, 3) systemic<br /><br>inflammation (hs-CRP, leukocytes, platelets, fibrinogen, TNF-a, IL-6).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/outcome of the study: 1) Predictors of COPD in CHF,<br /><br>2) systemic inflammation after conventional COPD treatment: hs-CRP, leukocytes,<br /><br>platelets, fibrinogen, TNF-a, IL-6, 3) association between inflammatory markers<br /><br>and various patient characteristics, 4) lung function abnormalities after<br /><br>conventional COPD treatment, 5) Quality of life and dyspnoea before and after<br /><br>conventional COPD treatment.</p><br>