Noninvasive Ventilation for Chronic Heart Failure

NCT05034549 | Unknown DMC

• 1 other identifier: Qilu-CHF
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Stable Heart Failure

Outcome Measures

Primary Outcomes (1)

• Cardiac remodeling

  The difference of left ventricular end diastolic volume (LVEDV) compared with baseline

  6 months

Study Arms (2)

Control

NO INTERVENTION

Noninvasive ventilation

EXPERIMENTAL

Device: Noninvasive ventilation

Interventions

Noninvasive ventilation DEVICE

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

Noninvasive ventilation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (3)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

RECRUITING

Jinan Central Hospital Affiliated to Shandong First Medical University

Jinan, China

RECRUITING

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: September 5, 2021
• Study Start: August 5, 2019
• Primary Completion: February 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)