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

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.

Study Overview

• Status: Completed
• Conditions: COPD; Heart Failure, Congestive
• Intervention / Treatment: Procedure: Lung function testing, echocardiography, blood sampling

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy, 41124
    • Azienda Ospedaliero-Universitaria di Modena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 93 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia
• Collaborators: Agenzia Italiana del Farmaco
• Investigators: Principal Investigator: Leonardo M Fabbri, MD, University of Modena and Reggio Emilia

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: April 30, 2010
• First Posted (Estimate): May 3, 2010

Study Record Updates

• Last Update Posted (Estimate): June 7, 2012
• Last Update Submitted That Met QC Criteria: June 6, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Exercise; Smoking; Cough; Dyspnea
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Heart Failure; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: RFPS-2006-8-334056