NCT01114386

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

Clinical, Functional and Biological Assessment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and/or Chronic Heart Failure(CHF) in Stable Conditions and During Exacerbation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: University of Modena and Reggio Emilia · Academic / Other
• Sex: All
• Age: 50 Years – 95 Years
• Healthy volunteers: Accepted

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.

Conditions

• COPD
• Heart Failure, Congestive

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-10-01
• Primary completion: 2011-07-01
• Completion: 2011-12-01
• First posted: 2010-05-03
• Last updated: 2012-06-07

Locations

1 site across 1 country: Italy