Status:
UNKNOWN
LTOT in COPD Patients With Moderate Chronic Hypoxemia and Chronic Heart Failure
Lead Sponsor:
Azienda Ospedaliero-Universitaria Careggi
Collaborating Sponsors:
University of Modena and Reggio Emilia
Conditions:
Lung Diseases, Obstructive
Chronic Heart Failure
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief Summary
In patients with both COPD and CHF, moderate chronic hypoxemia is caused by a combination of intrapulmonary and extrapulmonary factors. The hypothesis of this study is that adequate medical therapy fo...
Detailed Description
Long-term oxygen treatment (LTOT) improves survival of COPD patients with severe hypoxemia . The improved survival was proven in COPD patients with severe chronic hypoxemia (PaO2\< or = 55 mmHg), prov...
Eligibility Criteria
Inclusion
- Age 40 \> 80 years
- Confirmed COPD (GOLD criteria)
- Moderate and stable hypoxemia (55\< PaO2 \<65 mmHg)
- Clinical signs of CHF (ESC criteria)
- Ex-smokers (\> 20 pack/years) since at least 3 months
Exclusion
- Clinical instability and/or exacerbation
- Congenital heart diseases
- Lung cancer
- Thoracic restrictive disorders
- Other coexisting diseases influencing 3-yr survival
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00668408
Start Date
May 1 2008
End Date
October 1 2012
Last Update
August 28 2009
Active Locations (66)
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1
Ausl 8 di Arezzo
Arezzo, AR, Italy
2
Azienda Ospedaliera S. G. Moscati
Avellino, AV, Italy
3
A.O. Universitaria Ospedale consorziale policlinico di Bari
Bari, BA, Italy
4
Presidio ospedaliero Barletta
Barletta, BA, Italy