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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The aim of the present study is:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary function tests | Other | Patients underwent several pulmonary function tests (spirometry, diffusion measurement, body plethysmography) according to the study protocol 1 month after the first blood sample. COPD was diagnosed post-bronchodilation according to GOLD guidelines. Patients with newly diagnosed COPD received standard treatment for COPD. Spirometry was repeated after 3 months of standard treatment for COPD in patients with newly diagnosed COPD to confirm persistent airway obstruction (COPD) and thus exclude asthma. | ||
| Blood tests | Other | First blood sample (day 1): NT-pro-BNP, sodium, potassium, urea, creatinin, glomerular filtration rate (GFR). Second blood sample (after 1 month): NT-pro-BNP, sodium, potassium, urea, creatinin, GFR, haemoglobin, and arterial blood gas analysis in patients with GOLD III COPD. For systemic inflammation substudy also high sensitivity CRP, leukocytes, and platelets. Third blood sample (after 3 months from second blood sample): NT-pro-BNP, sodium, potassium, urea, creatinin, and GFR. | ||
| Questionnaires | Other | Minnesota Living with Heart Failure Questionnaire (MLHFQ), modified Medical Research Council (MRC) dyspnoea scale, 10-point Borg dyspnoea score. All questionnaires were completed on the day of initial pulmonary function tests and three months later. | ||
| Chest radiograph |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function abnormalities | Restriction, obstruction, diffusion impairment, mixed pulmonary defects | 1 day |
| COPD prevalence, underdiagnosis, and overdiagnosis | Patients with newly diagnosed COPD repeated spirometry after 3 months of standard treatment for COPD to confirm persistent airway obstruction (COPD) and thus exclude asthma. | 3 months |
| Systemic inflammation | Leukocytes, platelets, high sensitivity CRP. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Minnesota Living with Heart Failure Questionnaire (MLHFQ), on the day of initial pulmonary function tests and 3 months later. | 3 months |
| Dyspnoea | modified Medical Research Council (MRC) dyspnea scale and 10-point Borg dyspnoea score, on the day of initial pulmonary function tests and 3 months later. |
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Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria for the first primary objective:
Disorders/diseases that can lead to pulmonary function impairment:
Additional exclusion criteria for the third primary objective:
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| Name | Affiliation | Role |
|---|---|---|
| Armine G Minasian, MD | Rijnstate Hospital, Arnhem, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Gelderland | 6800 TA | Netherlands | ||
| Rijnstate Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26487748 | Derived | Minasian AG, van den Elshout FJ, Dekhuijzen PN, Vos PJ, Willems FF, van den Bergh PJ, Heijdra YF. Using the Lower Limit of Normal Instead of the Conventional Cutoff Values to Define Predictors of Pulmonary Function Impairment in Subjects With Chronic Heart Failure. Respir Care. 2016 Feb;61(2):173-83. doi: 10.4187/respcare.04101. Epub 2015 Oct 20. | |
| 25285269 |
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| Other |
Standard posteroanterior and lateral chest radiographs were performed and evaluated on the presence or absence of congestion and other conditions that belonged to the exclusion criteria. |
| 3 months |
| Independent predictors of COPD | Patients characterisitcs, such as age, gender, body mass index, symptoms, smoking history, family history, and so on. | 3 months |
| Zevenaar |
| Gelderland |
| 6903 ZN |
| Netherlands |
| Minasian AG, van den Elshout FJ, Dekhuijzen PR, Vos PJ, Willems FF, van den Bergh PJ, Heijdra YF. Serial pulmonary function tests to diagnose COPD in chronic heart failure. Transl Respir Med. 2014 Dec;2(1):12. doi: 10.1186/s40247-014-0012-5. Epub 2014 Sep 25. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D007249 | Inflammation |
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D006403 | Hematologic Tests |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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