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Clinical Assessment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and/or Chronic Heart Failure (CHF)

Recruiting
08/01/2009 to 12/01/2011
100
N/A
Observational
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.

Conditions

  • COPD
  • Heart Failure, Congestive

Eligibility

50 - 95
Yes
Inclusion Criteria:
- Caucasians
- Males and females
- Age > 50 years
- Smoking history > 10 pack years
- Diagnosis of COPD according to GOLD 2008 and/or diagnosis of CHF according to ESC
2008
Exclusion Criteria:
- History of bronchial asthma
- Fixed airflow limitation due to other chronic diseases such as cystic fibrosis,
bronchiolitis obliterans organizing pneumonia (BOOP), bronchiectasis, TBC etc.
- Combined restrictive-obstructive functional impairment

Purpose

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.

Interventions

  • Procedure: Lung function testing, echocardiography, blood sampling
    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

Contacts

Bianca Beghé, MD PhD
bianca.beghe@unimore.it
Alessia Verduri, MD PhD
alessia.verduri@unimore.it

Officials

  • Leonardo M Fabbri, MD
    Principal Investigator, University of Modena and Reggio Emilia

Locations

  • Azienda Ospedaliero-Universitaria di Modena
    Modena, 41124, Italy
    Recruiting
    Bianca Beghé, MD PhD
    0
    bianca.beghe@unimore.it
    Susanna Nerbano, Bsc
    0
    susanna.nerbano@unimore.it

    Investigators

    • Alessia Verduri, MD PhD
      Sub-Investigator
    • Bianca Beghé, MD PhD
      Sub-Investigator

Sponsors

  • University of Modena and Reggio Emilia
    Lead Sponsor
  • Italy: Ministry of Health

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