Health TrialsbyHealthPanel

Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function

ConditionChronic Obstructive Pulmonary Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorChina-Japan Friendship Hospital

About this trial

The goal of this type of study: clinical trial is to evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function.

Participants will undergo Lung volume reduction surgery with endobronchial valve implantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with Chronic Obstructive Pulmonary Disease

FEV1 ≤ 45% pred and FEV1/FVC<70%

TLC>100% pred and RV>175% pred

CAT score≥18

Disqualifiers

PaCO2>8.0 kPa, or PaO2<6.0 kPa

6-minute walk test<160m

Obvious chronic bronchitis, bronchiectasis or other infectious pulmonary diseases

More than 3 hospitalizations for pulmonary infection in the past 12 months before baseline assessment

Trial design

Design model

Single group

Treatments tested in this trial

  • Lung volume reduction surgery with endobronchial valve implantation

    Procedure/Surgery

    the patient would undergo Lung volume reduction surgery with endobronchial valve implantation

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Lung volume reduction surgery groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Baseline ventricular volume

cardiac magnetic resonance imaging

Time frame
Baseline
2

Ventricular volume （6 months after surgery）

cardiac magnetic resonance imaging

Time frame
6 months after surgery
3

Ventricular volume（12 months after surgery）

cardiac magnetic resonance imaging

Time frame
12 months after surgery
4

Baseline FEV1

Pulmonary function tests

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China-Japan Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now