Noninvasive Ventilation for Chronic Heart Failure

Not Applicable

• Conditions: Chronic Stable Heart Failure
• Interventions: Device: Noninvasive ventilation

• Registration Number: NCT05034549
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-05
• Study First Submitted: 2020-11-08
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-29
• Last Update Submitted: 2021-08-29
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05
• Primary Completion: 2023-02
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Noninvasive ventilation	Noninvasive ventilation	-

Primary Outcome Measures

Name	Time	Method
Cardiac remodeling	6 months	The difference of left ventricular end diastolic volume (LVEDV) compared with baseline

Trial Locations

Locations (3)

The First Affiliated Hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China

Jinan Central Hospital Affiliated to Shandong First Medical University; 🇨🇳 Jinan, China