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

Sponsor
China-Japan Friendship Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05775588
Collaborator
(none)
40
Enrollment
1
Arm
21.2
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Lung volume reduction surgery with endobronchial valve implantation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function in Patients With Lung Volume Reduction Surgery
Anticipated Study Start Date :
Mar 27, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lung volume reduction surgery group

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

Outcome Measures

Primary Outcome Measures

  1. Baseline ventricular volume [Baseline]

    cardiac magnetic resonance imaging

  2. Ventricular volume （6 months after surgery） [6 months after surgery]

    cardiac magnetic resonance imaging

  3. Ventricular volume（12 months after surgery） [12 months after surgery]

    cardiac magnetic resonance imaging

  4. Baseline FEV1 [Baseline]

    Pulmonary function tests

  5. FEV1 （6 months after surgery） [6 months after surgery]

    Pulmonary function tests

  6. FEV1（12 months after surgery） [12 months after surgery]

    Pulmonary function tests

  7. Baseline left Ventricular Ejection Fractions [Baseline]

    Echocardiography

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

    Echocardiography

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

    Echocardiography

  10. Baseline exercise tolerance [Baseline]

    6-minute walk test

  11. Exercise tolerance （6 months after surgery） [6 months after surgery]

    6-minute walk test

  12. Exercise tolerance （12 months after surgery） [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 [Baseline]

    St. George's Respiratory Questionnaire

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

    St. George's Respiratory Questionnaire

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

    St. George's Respiratory Questionnaire

  16. Baseline cross sectional area of rectus femoris [Baseline]

    Rectus femoris ultrasound

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

    Rectus femoris ultrasound

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

    Rectus femoris ultrasound

  19. Baseline mmuscle strength of lower limb [Baseline]

    Myometer

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

    Myometer

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

    Myometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • China-Japan Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gang Hou, Principal Investigator, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier:
NCT05775588
Other Study ID Numbers:
  • 2022-NHLHCRF-LX-01-0202-1
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 20, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Mar 20, 2023