Status:
COMPLETED
Pulmonary Function, Chronic Obstructive Pulmonary Disease (COPD) Prevalence, and Systemic Inflammation in Chronic Heart Failure With or Without COPD
Lead Sponsor:
Rijnstate Hospital
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Heart Failure
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the present study is: 1. To investigate pulmonary function abnormalities (restriction, obstruction, diffusion impairment, mixed pulmonary defects) in patients with chronic heart failure (C...
Detailed Description
1. The impact of chronic heart failure (CHF) on pulmonary function is incompletely understood and remains controversial. It is difficult to separate the contribution of stable CHF from underlying pulm...
Eligibility Criteria
Inclusion
- Chronic heart failure patients with left ventricular systolic dysfunction (left ventricular ejection fraction \< 40%)
- Outpatients
- New York Heart Association (NYHA) class I-IV
- 18 years and older
- Informed consent
Exclusion
- 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
- Malignancy with bad prognosis (survival \< 6 months)
- Hospitalisation to the pulmonary department in the past 6 weeks, in this case patients will have the pulmonary function tests ≥ 6 weeks after discharge
- Patients who are already participating in another study within the cardiology department
- Additional exclusion criteria for the first primary objective:
- Disorders/diseases that can lead to pulmonary function impairment:
- Pulmonary: lung surgery (lobectomy/pneumectomy), parenchymal neoplasms, interstitial lung disease, sarcoidosis, pneumoconioses, lung abscess, lobar pneumonia, post- infectious scarring, atelectasis, radiation fibrosis
- Pleural: diffuse pleural thickening, mesothelioma, pleural effusion not due to heart failure, pneumothorax
- Neuromuscular diseases: ALS, poliomyelitis, myopathy, bilateral diaphragmatic paralysis, high spinal cord lesions, myasthenia gravis
- Abdominal: obesity (BMI \> 35) (exclusion only from the restriction prevalence analysis)
- Pericardial: major pericardial effusion
- Large mediastinal processes
- Collagen vascular diseases
- Additional exclusion criteria for the third primary objective:
- Active/recent infection
- Febrile or inflammatory disease such as rheumatoid arthritis
- Use of antibiotics or anti-inflammatory medication, such as etanercept, infliximab, systemic use of corticosteroids and NSAID's other than acetylsalicylic acid
- Malignancy
- Auto-immune disease
- Collagenvascular disease
- Gastro-intestinal disease (such as inflammatory bowel disease)
- Recent operation (past 3 months)
- Renal or liver failure
- Thyroid disease
- Obstructive sleep apnoea syndrome (OSAS)
- Disorders that lead to thrombocytopenia/leukocytopenia or thrombocytosis/leukocytosis (hs-CRP analysis will take place in case these disorders do not affect hs-CRP)
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT01429376
Start Date
October 1 2009
End Date
June 1 2011
Last Update
September 7 2011
Active Locations (2)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA
2
Rijnstate Hospital
Zevenaar, Gelderland, Netherlands, 6903 ZN