Improvement of Cardiovascular Function After Bronchoscopic Lung Volume Reduction Using Endobronchial Valves

Summary

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

DIAGNOSTIC_TEST

Flow Mediated Dilation (FMD) measurement

FMD measurements will be performed by ultrasound using longitudinal images of the brachial artery using a high-frequency (10.0-MHz) ultrasound scanning probe (VividTM E9 with XDeclearTM; GE Healthcare, Chicago, Illinois, USA) proximal to the antecubital fossa. Two-dimensional images, acquired with electrocardiogram gating, 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 (or \> 50mmHg above systolic pressure) 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).

OTHER

Blood pressure, pulse and blood oxygen saturation measurement

Blood pressure measurement will be done with a pneumatic tourniquet on the upper arm, after at least 10 minutes rest of the patient. Pulse measurement and oxygen saturation measurement will be done using a finger pulseoximeter, after at least 10 minutes rest of the patient.

OTHER

ST George Respiratory Questionnaire

The is a validated and standardized Questionnaire designed to measure health impairment in COPD patients

OTHER

Physical activity level (PAL) measurement

PAL will be assessed by the number of steps and kilometers per day using 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. The device is worn always, except while showering or swimming.

BIOLOGICAL

Withdrawal of a blood sample

5ml of blood will be withdrawn and preserved after centrifugation at -50 degrees celsius for later analysis at a yet unknown time

PROCEDURE

Immediate Bronchoscopic Lung Volume Reduction

Bronchoscopic Lung Volume Reduction by using endobronchial valve placement Within 2 weeks after T0

PROCEDURE

Delayed Bronchoscopic Lung Volume Reduction

Bronchoscopic Lung Volume Reduction by using endobronchial valve placement Within 6-8 weeks after T0 and 3-4 days after T1

Sponsors & Collaborators

• Daniel Franzen

  lead OTHER

Principal Investigators

• Daniel Franzen, PD Dr. med. · Universitiy Hospital Zuich, Department of pulmonology

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-05

Primary Completion

2022-04-30

Completion

2022-04-30

Countries

• Switzerland

Study Locations