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Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary Disease

This study is currently recruiting participants.
Verified January 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01020344
First received: November 24, 2009
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Other: No LVRS group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (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
 Other: No LVRS group
No intervention

Detailed Description:

Not desired

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020344

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
Pulmonary Division, University Hospital of Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Malcolm Kohler, MD     0041 44 255 97 51     Malcolm.Kohler@usz.ch    
Contact: Anne C Stoewhas     0041 44 255 11 11        
Principal Investigator: Malcolm Kohler, MD            
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Malcolm Kohler, MD, Leading Physician University Hospital Zurich, Division of Pneumology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01020344     History of Changes
Other Study ID Numbers: COPD-CVD2
Study First Received: November 24, 2009
Last Updated: January 18, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013