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Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Information provided by (Responsible Party):
University of Zurich Identifier:
First received: November 24, 2009
Last updated: October 15, 2014
Last verified: October 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 Intervention
Chronic Obstructive Pulmonary Disease
Procedure: Lung volume reduction surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on the Cardiovascular Effects of Lung Volume Reduction Surgery in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 1. Systemic inflammation 2. Vascular function [ Time Frame: Before and 3 months after surgery/no surgery ]

Secondary Outcome Measures:
  • 1. Oxidative stress 2. Blood pressure 3. Physical Activity 4. Lung function 5. Hypoxemia [ Time Frame: Before and 3 months after surgery/no surgery ]

Enrollment: 30
Study Start Date: November 2009
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Not desired

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Dyspnea at rest or at minimal physical activity, severe limitation of exercise capacity (6-min walk distance < 350 m).
  • Acceptance of an increased perioperative mortality (approximately 2 %) and/or morbidity (long lasting hospitalization due to prolonged air leaks)
  • COPD (GOLD guidelines) with severe obstructive ventilatory defect (FEV1 <35% predicted)
  • Functional aspects of lung emphysema, i.e. irreversible hyperinflation with a residual volume to total lung capacity ratio (RV/TLC) of >0.65 and an impaired total lung diffusion capacity (DLCO), usually < 40% predicted.
  • Pulmonary emphysema confirmed by high resolution computer tomography

Exclusion criteria: - Current smokers

  • Age > 75years
  • "Vanishing" lung or diffuse lung emphysema on CT, FEV1 <20% predicted and DLCO <20% predicted, and hypercapnia (PaCO2 >7.3kPa)
  • Overt active coronary artery disease, severe left ventricular function impairment
  • Pulmonary hypertension with a mean pulmonary artery pressure >35 mmHg at rest
  • Acute bronchopulmonary infection, bronchiectasis on high resolution tomography
  • Pulmonary cachexia (body mass index <18kg/m2)
  • Neoplastic disease with a life expectancy of less than 2 years
  • Addiction to alcohol/drugs
  • Relevant renal (creatinine >150ug/ml), active gastroenterological (GI-bleeding in the previous year, abnormal liver function, active inflammatory bowel disease) or active neurological disease.
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Please refer to this study by its identifier: NCT01020344

Pulmonary Division, University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Principal Investigator: Malcolm Kohler, MD, Leading Physician University Hospital Zurich, Division of Pneumology
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Zurich Identifier: NCT01020344     History of Changes
Other Study ID Numbers: COPD-CVD2
Study First Received: November 24, 2009
Last Updated: October 15, 2014

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases processed this record on April 28, 2017