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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