Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT01020344|
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : October 16, 2014
A randomised controlled trial will be performed to evaluate the effects of lung volume reduction surgery (LVRS) in patients with COPD on systemic inflammation, oxidative stress, endothelial function, arterial stiffness and blood pressure. We hypothesize that LVRS will lead to a reduction of systemic inflammation, oxidative stress, arterial stiffness and blood pressure and to improved endothelial function.
For this purpose 30 patients with severe/very severe COPD (GOLD III-IV) and pulmonary emphysema who are to undergo LVRS will be randomised to one of two groups: group 1 receiving immediate LVRS and group 2 receiving LVRS after a delay of 3 months.
Measures of systemic inflammation, oxidative stress, endothelial function, arterial stiffness and blood pressure will be measured at baseline and 3 months after surgery and no surgery, respectively (group 2 receiving surgery only after a delay of 3 months will serve as control group) to investigate the effects of LVRS on the described outcomes.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Procedure: Lung volume reduction surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial on the Cardiovascular Effects of Lung Volume Reduction Surgery in Patients With Chronic Obstructive Pulmonary Disease|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Active Comparator: Lung volume reduction surgery
This group will receive lung volume reduction surgery
Procedure: Lung volume reduction surgery
Lung volume reduction surgery
No Intervention: No lung volume reduction surgery
This group will not receive LVRS during the 3 months of the study
- 1. Systemic inflammation 2. Vascular function [ Time Frame: Before and 3 months after surgery/no surgery ]
- 1. Oxidative stress 2. Blood pressure 3. Physical Activity 4. Lung function 5. Hypoxemia [ Time Frame: Before and 3 months after surgery/no surgery ]
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): NCT01020344
|Pulmonary Division, University Hospital of Zurich|
|Zurich, Switzerland, 8091|
|Principal Investigator:||Malcolm Kohler, MD, Leading Physician||University Hospital Zurich, Division of Pneumology|