Back to results

Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Lung volume reduction surgery

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Pulmonary Division, University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Lung volume reduction surgery

No lung volume reduction surgery

Arm Description

This group will receive lung volume reduction surgery

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

Outcomes

Primary Outcome Measures

1. Systemic inflammation 2. Vascular function

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01020344

First Posted

November 24, 2009

Last Updated

October 15, 2014

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT01020344

Brief Title

Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary Disease

Official Title

Randomized Controlled Trial on the Cardiovascular Effects of Lung Volume Reduction Surgery in Patients With Chronic Obstructive Pulmonary Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lung volume reduction surgery

Arm Type

Active Comparator

Arm Description

This group will receive lung volume reduction surgery

Arm Title

No lung volume reduction surgery

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Lung volume reduction surgery

Intervention Description

Lung volume reduction surgery

Primary Outcome Measure Information:

Title

1. Systemic inflammation 2. Vascular function

Time Frame

Before and 3 months after surgery/no surgery

Secondary Outcome Measure Information:

Title

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

Time Frame

Before and 3 months after surgery/no surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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: - 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Malcolm Kohler, MD, Leading Physician

Organizational Affiliation

University Hospital Zurich, Division of Pneumology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pulmonary Division, University Hospital of Zurich

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

26016823

Citation

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.

Results Reference

derived

Learn more about this trial

Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary Disease

We'll reach out to this number within 24 hrs