Clinical Assessment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and/or Chronic Heart Failure (CHF)
Condition: COPD; Heart Failure, Congestive
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Heart Failure
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Lung function testing, echocardiography, blood sampling
Intervention type(s): Procedure
Intervention description(s): All patients will undergo to:
physical examination
6' Minute Walk test
pulmonary function testing (spirometry + volumes and reversibility testing)
carbon monoxide diffusing capacity (DLCO) with single-breathe technique
ECG
echocardiography
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        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.
      
Biospecimen description: 
      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.
    
Keywords: Smoking; Dyspnea; Cough; Exercise