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

NCT ID: NCT01114386

Last Updated: 2012-06-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2011-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Lung function testing, echocardiography, blood sampling

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agenzia Italiana del Farmaco

OTHER_GOV

Sponsor Role: collaborator

University of Modena and Reggio Emilia

OTHER

Sponsor Role: lead

Responsible Party

Leonardo M. Fabbri

Professor Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leonardo M Fabbri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Modena and Reggio Emilia

Locations

Azienda Ospedaliero-Universitaria di Modena

Modena, Modena, Italy

Countries

Italy

Other Identifiers

RFPS-2006-8-334056

Identifier Type: -

Identifier Source: org_study_id