Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT01020344

Last Updated: 2014-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2014-10-31

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.

Detailed Description

Not desired

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lung volume reduction surgery

This group will receive lung volume reduction surgery

Group Type: ACTIVE_COMPARATOR

Lung volume reduction surgery

Intervention Type: PROCEDURE

Lung volume reduction surgery

No lung volume reduction surgery

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lung volume reduction surgery

Lung volume reduction surgery

Intervention Type: PROCEDURE

Eligibility 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

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malcolm Kohler, MD, Leading Physician

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Pneumology

Locations

Pulmonary Division, University Hospital of Zurich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 26016823 (View on PubMed)

Other Identifiers

COPD-CVD2

Identifier Type: -

Identifier Source: org_study_id