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NCT Number: NCT05775588

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

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.

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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

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Chronic Obstructive Pulmonary Disease
  • FEV1 ≤ 45% pred and FEV1/FVC<70%
  • TLC>100% pred and RV>175% pred
  • CAT score≥18
  • Emphysema damage>50%
  • Complete interlobar fissure >95% based on quantitative analysis of CT measurement
  • No smoking>6 months
  • Sign the informed consent form

Exclusion criteria

  • 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
  • Previous lobectomy, LVRS or lung transplantation
  • LVEF<45% and or RVSP>50mmHg
  • Anticoagulant therapy that cannot be stopped before surgery
  • Patients with obvious immune deficiency
  • Participated in other lung drug studies within the first 30 days of this study
  • Pulmonary nodules requiring intervention
  • Any disease or condition that interferes with the completion of the initial or subsequent assessment

Treatment and study plan

Lung volume reduction surgery with endobronchial valve implantation

Procedure

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

Primary outcomes

  1. Baseline ventricular volume

    Time frame: Baseline

    cardiac magnetic resonance imaging

  2. Ventricular volume （6 months after surgery）

    Time frame: 6 months after surgery

    cardiac magnetic resonance imaging

  3. Ventricular volume（12 months after surgery）

    Time frame: 12 months after surgery

    cardiac magnetic resonance imaging

  4. Baseline FEV1

    Time frame: Baseline

    Pulmonary function tests

  5. FEV1 （6 months after surgery）

    Time frame: 6 months after surgery

    Pulmonary function tests

  6. FEV1（12 months after surgery）

    Time frame: 12 months after surgery

    Pulmonary function tests

  7. Baseline left Ventricular Ejection Fractions

    Time frame: Baseline

    Echocardiography

  8. Left Ventricular Ejection Fractions （6 months after surgery）

    Time frame: 6 months after surgery

    Echocardiography

  9. Left Ventricular Ejection Fractions （12 months after surgery）

    Time frame: 12 months after surgery

    Echocardiography

  10. Baseline exercise tolerance

    Time frame: Baseline

    6-minute walk test

  11. Exercise tolerance （6 months after surgery）

    Time frame: 6 months after surgery

    6-minute walk test

  12. Exercise tolerance （12 months after surgery）

    Time frame: 12 months after surgery

    6-minute walk test

  13. Baseline health impairment and quality of life of patients Baseline health impairment and quality of life of patients

    Time frame: Baseline

    St. George's Respiratory Questionnaire

  14. Health impairment and quality of life of patients （6 months after surgery）

    Time frame: 6 months after surgery

    St. George's Respiratory Questionnaire

  15. Health impairment and quality of life of patients （12 months after surgery）

    Time frame: 12 months after surgery

    St. George's Respiratory Questionnaire

  16. Baseline cross sectional area of rectus femoris

    Time frame: Baseline

    Rectus femoris ultrasound

  17. Cross sectional area of rectus femoris （6 months after surgery）

    Time frame: 6 months after surgery

    Rectus femoris ultrasound

  18. Cross sectional area of rectus femoris （12 months after surgery）

    Time frame: 12 months after surgery

    Rectus femoris ultrasound

  19. Baseline mmuscle strength of lower limb

    Time frame: Baseline

    Myometer

  20. Mmuscle strength of lower limb （6 months after surgery）

    Time frame: 6 months after surgery

    Myometer

  21. Mmuscle strength of lower limb （12 months after surgery）

    Time frame: 12 months after surgery

    Myometer

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function in Patients With Lung Volume Reduction Surgery

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2023
Registry last updated
Aug 6, 2026

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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