Noninvasive Ventilation for Chronic Heart Failure

NCT ID: NCT05034549

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-05

Study Completion Date

2023-08-31

Brief Summary

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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

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Conditions

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Chronic Stable Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Noninvasive ventilation

Group Type EXPERIMENTAL

Noninvasive ventilation

Intervention Type DEVICE

The non-invasive ventilator at home (≥5h/ night)

Interventions

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Noninvasive ventilation

The non-invasive ventilator at home (≥5h/ night)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Pan-Pan Hao

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Site Status RECRUITING

Jinan Central Hospital Affiliated to Shandong First Medical University

Jinan, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Panpan Hao, MD, PhD

Role: primary

86-18560086593

Zhongwen Zhang

Role: primary

18560005233

Bin Li, MD

Role: primary

13370586671

Other Identifiers

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Qilu-CHF

Identifier Type: -

Identifier Source: org_study_id

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