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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05034549
Other study ID # Qilu-CHF
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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