Clinical Assessment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and/or Chronic Heart Failure (CHF)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01114386 |
Recruitment Status
:
Completed
First Posted
: May 3, 2010
Last Update Posted
: June 7, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
COPD Heart Failure, Congestive | Procedure: Lung function testing, echocardiography, blood sampling |
Study Type : | Observational |
Actual Enrollment : | 100 participants |
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 |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | December 2011 |

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:
|
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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 95 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114386
Italy | |
Azienda Ospedaliero-Universitaria di Modena | |
Modena, Italy, 41124 |
Principal Investigator: | Leonardo M Fabbri, MD | University of Modena and Reggio Emilia |
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 |
First Posted: | May 3, 2010 Key Record Dates |
Last Update Posted: | June 7, 2012 |
Last Verified: | June 2012 |
Keywords provided by Leonardo M. Fabbri, University of Modena and Reggio Emilia:
Smoking Dyspnea Cough Exercise |
Additional relevant MeSH terms:
Heart Failure Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive |
Heart Diseases Cardiovascular Diseases Respiratory Tract Diseases |