Noninvasive Ventilation for Chronic Heart Failure

Chronic Stable Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05034549
• Other study ID #: Qilu-CHF
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: August 2023

Study information

• Verified date: August 2021
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Stable Heart Failure
• Heart Failure

Intervention

Device:
• Noninvasive ventilation
The non-invasive ventilator at home (=5h/ night)

Locations

Country	Name	City	State
China	Jinan Central Hospital Affiliated to Shandong First Medical University	Jinan
China	Qilu Hospital, Shandong University	Jinan	Shandong
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac remodeling	The difference of left ventricular end diastolic volume (LVEDV) compared with baseline	6 months