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Noninvasive Ventilation for Chronic Heart Failure

S

Shandong University

Status

Unknown

Conditions

Chronic Stable Heart Failure

Treatments

Device: Noninvasive ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT05034549
Qilu-CHF

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Control
No Intervention group
Noninvasive ventilation
Experimental group
Treatment:
Device: Noninvasive ventilation

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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