Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary Disease

NCT01020344 | Completed

• 1 other identifier: COPD-CVD2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 1. Systemic inflammation 2. Vascular function

  Before and 3 months after surgery/no surgery

Secondary Outcomes (1)

• 1. Oxidative stress 2. Blood pressure 3. Physical Activity 4. Lung function 5. Hypoxemia

  Before and 3 months after surgery/no surgery

Study Arms (2)

Lung volume reduction surgery

ACTIVE COMPARATOR

This group will receive lung volume reduction surgery

Procedure: Lung volume reduction surgery

No lung volume reduction surgery

NO INTERVENTION

This group will not receive LVRS during the 3 months of the study

Interventions

Lung volume reduction surgery PROCEDURE

Lung volume reduction surgery

Lung volume reduction surgery

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Pulmonary Division, University Hospital of Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Clarenbach CF, Sievi NA, Brock M, Schneiter D, Weder W, Kohler M. Lung Volume Reduction Surgery and Improvement of Endothelial Function and Blood Pressure in Patients with Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2015 Aug 1;192(3):307-14. doi: 10.1164/rccm.201503-0453OC.

  PMID: 26016823 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Malcolm Kohler, MD, Leading Physician

  University Hospital Zurich, Division of Pneumology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 16, 2014

Record last verified: 2014-10

Locations

CH (1)