Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Improvement of Cardiovascular Function After Bronchoscopic Lung Volume Reduction Using Endobronchial Valves in Patients With Severe Emphysema: A Randomized Controlled Trial
NCT number | NCT04556942 |
Other study ID # | 2019-01682 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 5, 2020 |
Est. completion date | April 30, 2022 |
There is increasing evidence showing an association between COPD and cardiovascular disease
which is independent from smoking. Recently, it has been shown that FMD of the brachial
artery, a surrogate marker of endothelial function, is improving after lung volume reduction
surgery (LVRS) in patients with severe emphysema. Thus, hyperinflation might be an
independent risk factor of atherosclerosis. Bronchoscopic lung volume reduction (BLVR) using
endobronchial valves is a minimal-invasive procedure to decrease hyperinflation in patients
with severe emphysema. Eventually, successful BLVR with target atelectasis may have the same
effect on FMD compared to LVRS, which would underpin the association between hyperinflation
and endothelial function.
Patients receiving routinely performed BLVR using endobronchial valves due to severe
emphysema with hyperinflation are eligible for this study. After obtaining written informed
consent, the participating patients will be randomized into an immediate (within 1-2 weeks)
BLVR group and a delayed BLVR group (6-8 weeks). Patients in both groups will undergo
baseline measurement of primary and secondary endpoints.
Immediate BLVR group will be re-assessed 4-6 weeks after successful EBV treatment, whereas
the delayed BLVR group will be re-assessed prior EBV treatment. Results of group 1 and 2 will
be compared for final analysis.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | April 30, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Male or female subject between 40 and 75 years of age - Written informed consent after participant's information signed by patient - Scheduled for BLVR using endobronchial valves at the University Hospital Zurich - Dyspnoea at rest or at minimal physical activity (MRC score =2), severe limitation of exercise capacity (6-min walk distance < 500 m). - COPD (GOLD guidelines) with severe obstructive ventilator defect (FEV1 <40% predicted) - Functional aspects of lung emphysema with irreversible hyperinflation, defined as a residual volume to total lung capacity ratio (RV/TLC) of >0.6 - Pulmonary emphysema confirmed by high resolution computer tomography Exclusion Criteria: - Age < 40 years, age > 75 years - COPD exacerbation within the last 6 weeks or > 2 exacerbations per year - Pregnancy - Lacking ability to form an informed consent (including impaired judgement, communication barriers) - Current smokers - Overt active coronary artery disease, 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) - Malignant disease with a life expectancy of less than 2 years - Addiction to alcohol/drugs (= inability to withhold intake during 1 week) |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich, Department of Pulmonology | Zurich |
Lead Sponsor | Collaborator |
---|---|
Daniel Franzen |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postinterventional change in endothelial function assessed by flow mediated dilation (FMD) (%) before and after the bronchoscopic lung volume reduction (BLVR). | FMD will be performed by ultrasound using longitudinal images of the brachial artery proximal to the antecubital fossa. Two-dimensional images will be obtained at baseline with Doppler ultrasound imaging to assess arterial diameter and flow velocity. Reactive hyperemia will then be induced by inflation of a pneumatic tourniquet around the forearm to at least 200 mm Hg for 5 minutes. Post-deflation diameter and flow velocity will be monitored continuously from deflation for 210 seconds. To assess endothelial-independent vasodilation maximal brachial artery diameter will be measured continuously for 3 minutes after a single sublingual dose of nitroglycerin (NTG, 0.4 mg). Brachial artery diameter will be measured automatically at the onset of the R wave with dedicated software. Results of endothelial-dependent (FMD) and endothelial-independent (NTG) vasodilation will be expressed as percent change in arterial diameter from the baseline diameter | FMD measurement will be done at baseline and once again within 6-8 weeks afterwards. | |
Secondary | Physical activity level (PAL) measuring the steps per day, converting that into a distance in kilometers per day | PAL will be assessed by the measurement of the number of steps per day. The device will calculate from the number of steps per day the distance in kilometers per day knowing the height of the patient. The height will be programmed into the device beforehand. To measure the steps per day the investigator uses a triaxial accelerometer of a multisensory activity monitor (Fitbit Alta HR; Fitbit Inc., San Francisco, CA, USA). The device is worn like a watch on the wrist of the patient. The device is worn always, except while showering or swimming. At both visits patients will receive the device and wear it for seven days for data collection and send it back via postal mail afterwards. |
Measurement at baseline and once again within 6-8 weeks afterwards. | |
Secondary | Blood pressure (mmHg) | Measurement of the systolic and diastolic blood pressure is done after 10 minutes of rest using a pneumatic tourniquet and a pulseoximeter. | Measurement at baseline and once again within 6-8 weeks afterwards. | |
Secondary | Heart rate (beats per minute) | Measurement is done after 10 minutes of rest using a pulseoximeter. | Measurement at baseline and once again within 6-8 weeks afterwards. | |
Secondary | Blood oxygen saturation (%) | Measurement is done after 10 minutes of rest using a pulseoximeter. | Measurement at baseline and once again within 6-8 weeks afterwards. | |
Secondary | St. George Respiratory Questionnaire (SGRQ) | Standardized questionaire to assess the health impaired through COPD. It is in two parts. Part I produces the Symptoms score, and Part 2 the Activity and Impacts scores. A Total score is also produced. An excel-based scoring calculator is used to analyze the collected data. All positive responses are entered as 1 and all negative responses are entered as 0. Three component scores are calculated for the SGRQ: Symptoms: this component is concerned with the effect of respiratory symptoms, their frequency and severity. Activity: concerned with activities that cause or are limited by breathlessness Impacts: covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease A Total score is also calculated which summarises the impact of the disease on overall health status. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. |
Measurement at baseline and once again within 6-8 weeks afterwards. | |
Secondary | 6-minute walking distance (6-MWD) in meters | This assessment is not study specific. It is done during the regular assessment before BLVR and repeated after BLVR. It measures the distance a patient can go within 6 minutes. | Done during the routine visit before BLVR, which is before the study phase and it will be repeated during the routine follow-up 4-6 weeks after BLVR | |
Secondary | Forced Expiratory Volume in first second (FEV1) in liters | This assessment is not study specific. It is done during the regular assessment before BLVR and repeated after BLVR. It measures the volume in liters that is exhaled during the first second of forced exhalation during a pulmonary function test. | Done during the routine visit before BLVR, which is before the study phase and it will be repeated during the routine follow-up 4-6 weeks after BLVR | |
Secondary | Residual Volume (RV) in liters | This assessment is not study specific. It is done during the regular assessment before BLVR and repeated after BLVR. During a pulmonary function test it measures the volume in liters that remains in the lungs after maximal exhalation . | Done during the routine visit before BLVR, which is before the study phase and it will be repeated during the routine follow-up 4-6 weeks after BLVR | |
Secondary | Residual Volume (RV)/ Total Lung Capacity (TLC) in percentage | This assessment is not study specific. It is done during the regular assessment before BLVR and repeated after BLVR. During a pulmonary function test it measures the Residual Volume to Total Lung Capacity Ratio expressed as percentage. | Done during the routine visit before BLVR, which is before the study phase and it will be repeated during the routine follow-up 4-6 weeks after BLVR | |
Secondary | CO-Diffusion Capacity (DLCO) in percentage | This assessment is not study specific. It is done during the regular assessment before BLVR and repeated after BLVR. It measures the transfer of gas from air in the lung, to the red blood cells in lung blood vessels. It is part of a comprehensive series of pulmonary function tests to determine the overall ability of the lung to transport gas into and out of the blood. | Done during the routine visit before BLVR, which is before the study phase and it will be repeated during the routine follow-up 4-6 weeks after BLVR | |
Secondary | Number of participants with relevant change in C-reactive protein before and after BLVR | This assessment is not study specific. In the blood C-reactive protein will be measured. It is done during the regular assessment before BLVR and repeated after BLVR. The investigator will observe if the value changes before and after the intervention. | Done during the routine visit before BLVR, which is before the study phase and it will be repeated during the routine follow-up 4-6 weeks after BLVR | |
Secondary | Number of participants with relevant change NT-proBNP before and after BLVR | This assessment is not study specific. In the blood NT-pro-BNP will be measured. It is done during the regular assessment before BLVR and repeated after BLVR. The investigator will observe if the value changes before and after the intervention. | Done during the routine visit before BLVR, which before is the study phase and it will be repeated during the routine follow-up 4-6 weeks after BLVR |
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