Heart Failure and Sleep Disordered Breathing

June 28, 2023 updated by: Yihui Kong

Characteristics of Arrhythmia and Heart Rate Variability in Patients With Heart Failure and Sleep Disordered Breathing

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Recruiting
        • Yihui Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Heart failure patients hospitalized in the Department of Cardiology of the First Affiliated Hospital of Harbin Medical University

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart failure and sleep apnea
Time Frame: 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-disordered breathing based on the clinical data. Collection of clinical data: general clinical data, physical signs, post-admission inspection indicators, and treatment conditions of patients collected from the electronic medical record system. Echocardiographic data mainly included ejection fraction, left atrial anterior-posterior diameter, and interventricular septum thickness, which were in millimeters; electrocardiogram examination mainly included Diagnosis type of arrhythmia by dynamic, the overall standard deviation of normal sinus R-R interval (SDNN), the average standard deviation of normal sinus R-R interval throughout the recording period (SDANN), which were in a millisecond, etc; The type and severity of sleep-disordered breathing and Apnea hypopnea index were obtained by polysomnography.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yihui Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 28, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

May 27, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021020707

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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