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Completed

NCT Number: NCT01020344

Mechanisms of Vascular Damage 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.

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Key information

Conditions

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

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary Division, University Hospital of Zurich

Zurich, 8091, Switzerland

About this study

Not desired

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung volume reduction surgery

Procedure

Lung volume reduction surgery

Primary outcomes

  1. 1. Systemic inflammation 2. Vascular function

    Time frame: 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

    Time frame: Before and 3 months after surgery/no surgery

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Nov 25, 2009
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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