Noninvasive Ventilation for Chronic Heart Failure

Study Overview
=================
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.

Official Title
-----------------
Efficacy and Safety of Home Non-invasive Ventilation Based on Polysomnography in Chronic Stable Heart Failure

Conditions
-----------------
Chronic Stable Heart Failure

Intervention / Treatment
-----------------
* Device: Noninvasive ventilation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Noninvasive ventilation<br> | Device: Noninvasive ventilation<br>* The non-invasive ventilator at home (≥5h/ night)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac remodeling | The difference of left ventricular end diastolic volume (LVEDV) compared with baseline | 6 months |