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

This study has been completed.
Sponsor:
Collaborator:
Agenzia Italiana del Farmaco
Information provided by (Responsible Party):
Leonardo M. Fabbri, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01114386
First received: April 30, 2010
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
COPD
Heart Failure, Congestive
Procedure: Lung function testing, echocardiography, blood sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Modena and Reggio Emilia:

Biospecimen Retention:   Samples Without DNA

Blood sampling for routine (haemachrome and differential cells blood count, bilirubin, cholesterol, high density lipoprotein, low density lipoprotein, glycemia, blood urea, blood electrolytes (sodium, potassium, chloride), glutamic-oxaloacetic transaminase, glutamic-pyruvic transaminase, γGT, triglycerides, creatinine, uric acid, creatine phosphokinase, glycosylated haemoglobin).

Blood sampling for selected biomarkers: NTBNP, HS-PCR and IL-6, IL1-β, cellular receptor D6 and TIR8, IL-1 decoy receptor PTX3.

Measurement of arterial blood gases.


Enrollment: 100
Study Start Date: October 2006
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114386

Locations
Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy, 41124
Sponsors and Collaborators
University of Modena and Reggio Emilia
Agenzia Italiana del Farmaco
Investigators
Principal Investigator: Leonardo M Fabbri, MD University of Modena and Reggio Emilia
  More Information

No publications provided

Responsible Party: Leonardo M. Fabbri, Professor Medical Doctor, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01114386     History of Changes
Other Study ID Numbers: RFPS-2006-8-334056
Study First Received: April 30, 2010
Last Updated: June 6, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by University of Modena and Reggio Emilia:
Smoking
Dyspnea
Cough
Exercise

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014