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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
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stable Heart Failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 8, 2020
Last Updated
August 29, 2021
Sponsor
Qilu Hospital of Shandong University
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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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