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Heart Failure and Sleep Disordered Breathing

Sponsor
Yihui Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05892172
Collaborator
(none)
300
Enrollment
1
Location
11.1
Anticipated Duration (Months)
26.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to analyze and summarize the characteristics of arrhythmia and heart rate variability of Chinese patients with three different types of heart failure combined with sleep disordered breathing based on the clinical data, to provide new diagnosis and treatment ideas for domestic patients, and then to improve the prognosis of patients betterly.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Characteristics of Arrhythmia and Heart Rate Variability in Patients With Heart Failure and Sleep Disordered Breathing
    Anticipated Study Start Date :
    May 27, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Apr 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    HFrEF group

    HFrEF was defined as Left ventricular ejection fraction ≤40%
    HFmrEF group

    HFmrEF was defined as Left ventricular ejection fraction 41%~49%
    HFpEF group

    HFpEF was defined as Left ventricular ejection fraction ≥50%

    Outcome Measures

    Primary Outcome Measures

    1. heart failure and sleep apnea [24 hours]

      analyze and summarize the characteristics of arrhythmia and heart rate variability of Chinese patients with three different types of heart failure combined with sleep apnea based on the clinical data.Echocardiographic data mainly included ejection fraction, left atrial anterior-posterior diameter, left ventricular end-diastolic diameter, and interventricular septum thickness, which were obtained by M-type measurement or Simpson method；electrocardiogram examination mainly included Diagnosis type of arrhythmia , the overall standard deviation of normal sinus R-R interval (SDNN),low frequency (LF), high frequency (HF), energy ratio between low frequency and high frequency (LF/HF), etc; Standardized definitions of all cardiac arrhythmias were applied according to the current EHRA/HRS/APHRS Expert Consensus statement;The type of sleep-disordered breathing, the severity of sleep-disordered breathing, Apnea hypopnea index (AHI), and minimum oxygen saturation were obtained by polysomnography.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Age >18 years.

    2. The diagnosis of heart failure conforms to the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure .

    3. Echocardiography, dynamic electrocardiogram and polysomnography monitoring should be improved during the period of hospitalization.

    4. Patients with sleep apnea have not received standard treatment.

    Exclusion Criteria:

    1. Patients undergoing cardiac surgery in the past 6 weeks.

    2. Patients with acute decompensated heart failure or heart failure requiring oxygen therapy.

    3. All patients with sleep apnea who receive standard treatment.

    4. Patients who use pacemakers or implantable cardioverter defibrillators.

    5. The patient did not complete the echocardiography, dynamic electrocardiogram, and polysomnography monitoring during hospitalization.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yihui Kong Harbin Heilongjiang China 150000

    Sponsors and Collaborators

    • Yihui Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yihui Kong, Professor, First Affiliated Hospital of Harbin Medical University
    ClinicalTrials.gov Identifier:
    NCT05892172
    Other Study ID Numbers:
    • 2021020707
    First Posted:
    Jun 7, 2023
    Last Update Posted:
    Jun 7, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yihui Kong, Professor, First Affiliated Hospital of Harbin Medical University
    sleep disordered breathing
    arrhythmia
    heart rate variability
    Additional relevant MeSH terms:
    Sleep Apnea Syndromes
    Heart Failure

    Study Results

    No Results Posted as of Jun 7, 2023