Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01020344
First received: November 24, 2009
Last updated: December 20, 2013
Last verified: December 2013

November 24, 2009
December 20, 2013
November 2009
December 2014   (final data collection date for primary outcome measure)
1. Systemic inflammation 2. Vascular function [ Time Frame: Before and 3 months after surgery/no surgery ] [ Designated as safety issue: No ]
1. Systemic inflammation (CRP, inflammatory cytokines) 2. Oxidative stress (Malondialdehyde) 3. Endothelial function (flow mediated dilatation and pulse wave analysis) 4. Arterial stiffness (pulse wave analysis) 5. Blood pressure
Complete list of historical versions of study NCT01020344 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary Disease
Randomized Controlled Trial on the Cardiovascular Effects of Lung Volume Reduction Surgery in Patients With Chronic Obstructive Pulmonary Disease

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.

Not desired

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
Procedure: Lung volume reduction surgery
Lung volume reduction surgery
  • Active Comparator: Lung volume reduction surgery
    This group will receive lung volume reduction surgery
    Intervention: Procedure: Lung volume reduction surgery
  • No Intervention: No lung volume reduction surgery
    This group will not receive LVRS during the 3 months of the study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
40 Years to 75 Years
No
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11
Switzerland
 
NCT01020344
COPD-CVD2
No
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Malcolm Kohler, MD, Leading Physician University Hospital Zurich, Division of Pneumology
University of Zurich
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP