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| Name | Class |
|---|---|
| Agenzia Italiana del Farmaco | OTHER_GOV |
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Cigarette smoking, the major risk factor for COPD, causes not only airway and lung inflammation, but also systemic effects. These systemic effects of smoking could substantially contribute to the development of chronic diseases, other than COPD, particularly chronic heart failure (CHF). The aim of this project is to assess the frequency and severity of CHF and COPD in outpatients with history of smoking referred to Hospital because of dyspnea and/or chronic cough.
We will recruit 100 patients older than 50 years with diagnosis of COPD and/or CHF. COPD is defined by presence of fixed airflow obstruction (post-bronchodilator FEV1/FVC less than 70%) according to Global Initiative for Obstructive Lung Disease (GOLD) guidelines. Each patient will be characterized by medical history and physical examination. Patients with a diagnosis of COPD must have: 1) had a history of chronic respiratory symptoms, i.e., cough and sputum and/or breathlessness and only occasional wheezing (SGRQ and MMRC Questionnaire); 2) they had to be smokers or ex-smokers with more than 10 pack-years, and 3) a documented absence of a history of variable airflow obstruction and/or diagnosis of asthma. Each patient will perform pulmonary function tests, including reversibility to inhaled bronchodilator (400 µg albuterol); arterial blood gases, and routine blood tests. In addition, each patient will undergo regular PA/LL chest x-ray. The diagnosis of CHF is established according to the criteria of European Society of Cardiology. At time of entry in the study, all patients will be in clinically stable condition (ie, no changes in medication dosage or frequency, and no exacerbations of disease or hospital admissions in the preceding 6 weeks). Clinical and biological follow-up of these patients will be prospectively followed for 2 years, from 2009 to 2011.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD patients, CHF patients | COPD and CHF patients with smoking history (> 10 pack/years), male and female, older than 50 years, referred to Hospital for dyspnea and chronic cough. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung function testing, echocardiography, blood sampling | Procedure | All patients will undergo to:
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Inclusion Criteria:
Exclusion Criteria:
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100 patients older than 50 years with diagnosis of COPD and/or CHF, male or female, smokers or ex-smokers with more than 10 pack-years, in stable conditions.
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| Name | Affiliation | Role |
|---|---|---|
| Leonardo M Fabbri, MD | University of Modena and Reggio Emilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria di Modena | Modena | Modena | 41124 | Italy |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006333 | Heart Failure |
| D012907 | Smoking |
| D004417 | Dyspnea |
| D003371 | Cough |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood sampling for routine (haemachrome and differential cells blood count, bilirubin, cholesterol, high density lipoprotein, low density lipoprotein, glycemia, blood urea, blood electrolytes (sodium, potassium, chloride), glutamic-oxaloacetic transaminase, glutamic-pyruvic transaminase, γGT, triglycerides, creatinine, uric acid, creatine phosphokinase, glycosylated haemoglobin).
Blood sampling for selected biomarkers: NTBNP, HS-PCR and IL-6, IL1-β, cellular receptor D6 and TIR8, IL-1 decoy receptor PTX3.
Measurement of arterial blood gases.
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |