Noninvasive Ventilation for Chronic Heart Failure
Primary Purpose
Chronic Stable Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Noninvasive ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Stable Heart Failure
Eligibility Criteria
Inclusion Criteria:
- 1) The history of chronic stable heart failure exceeds 3 months; 2) 18~75 years old; 3) NYHA cardiac function classified as grade II~IV; 4) LVEF≤40%; 5) NT-proBNP≥450pg/ml; 6) All subjects or their guardians must sign the subject consent before entering the trial.
Exclusion Criteria:
- 1) Patients with the following diseases: valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; acute coronary syndrome; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor; 2) Patients with poor sound transmission windows are examined by transthoracic ultrasound.
Sites / Locations
- Qilu Hospital, Shandong UniversityRecruiting
- The First Affiliated Hospital of Shandong First Medical UniversityRecruiting
- Jinan Central Hospital Affiliated to Shandong First Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Noninvasive ventilation
Arm Description
Outcomes
Primary Outcome Measures
Cardiac remodeling
The difference of left ventricular end diastolic volume (LVEDV) compared with baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT05034549
First Posted
November 8, 2020
Last Updated
August 29, 2021
Sponsor
Qilu Hospital of Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT05034549
Brief Title
Noninvasive Ventilation for Chronic Heart Failure
Official Title
Efficacy and Safety of Home Non-invasive Ventilation Based on Polysomnography in Chronic Stable Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qilu Hospital of Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The effects of home noninvasive ventilation on renin-angiotensin system (RAS), kallikrein-kinin system (KKS) and cardiac remodeling in patients with chronic stable heart failure have not been reported. This project aims to clarify the efficacy and safety of home non-invasive ventilation in patients with chronic heart failure complicated with sleep-disordered breathing. First, patients with chronic stable heart failure were selected and monitored by polysomnography. Patients with sleep apnea hypopnea syndrome (SAHS, AHI≥15) were randomly divided into two groups: the treatment group was treated with non-invasive ventilator at home (≥5h/ night); The control group was only given routine treatment. After 6 months of follow-up, the effects of sleep disordered breathing and noninvasive ventilation on RAS, KKS, cardiac remodeling and function and cardiovascular adverse events in patients with chronic heart failure were evaluated. The results are helpful to further reveal the role of sleep disordered breathing in the occurrence and development of chronic heart failure, and provide a new diagnosis and treatment strategy for chronic heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Noninvasive ventilation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Noninvasive ventilation
Intervention Description
The non-invasive ventilator at home (≥5h/ night)
Primary Outcome Measure Information:
Title
Cardiac remodeling
Description
The difference of left ventricular end diastolic volume (LVEDV) compared with baseline
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) The history of chronic stable heart failure exceeds 3 months; 2) 18~75 years old; 3) NYHA cardiac function classified as grade II~IV; 4) LVEF≤40%; 5) NT-proBNP≥450pg/ml; 6) All subjects or their guardians must sign the subject consent before entering the trial.
Exclusion Criteria:
1) Patients with the following diseases: valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; acute coronary syndrome; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor; 2) Patients with poor sound transmission windows are examined by transthoracic ultrasound.
Facility Information:
Facility Name
Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panpan Hao, MD, PhD
Phone
86-18560086593
Email
panda.how@126.com
First Name & Middle Initial & Last Name & Degree
Yanping Liu, MD, PhD
First Name & Middle Initial & Last Name & Degree
Panpan Hao, MD, PhD
First Name & Middle Initial & Last Name & Degree
Guishuang Li, MD
Facility Name
The First Affiliated Hospital of Shandong First Medical University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongwen Zhang
Phone
18560005233
Email
zhangzhongwen521@126.com
First Name & Middle Initial & Last Name & Degree
Zhongwen Zhang, MD
Facility Name
Jinan Central Hospital Affiliated to Shandong First Medical University
City
Jinan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Li, MD
Phone
13370586671
Email
qingquan0615@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Noninvasive Ventilation for Chronic Heart Failure
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