Heart Failure and Sleep Disordered Breathing

NCT05892172 | Unknown

• 1 other identifier: 2021020707
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

sleep disordered breathing; arrhythmia; heart rate variability

Outcome Measures

Primary Outcomes (1)

• heart failure and sleep apnea

  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

Study Arms (3)

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%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age \>18 years.
• The diagnosis of heart failure conforms to the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure .
• Echocardiography, dynamic electrocardiogram and polysomnography monitoring should be improved during the period of hospitalization.
• Patients with sleep apnea have not received standard treatment.

You may not qualify if:

• Patients undergoing cardiac surgery in the past 6 weeks.
• Patients with acute decompensated heart failure or heart failure requiring oxygen therapy.
• All patients with sleep apnea who receive standard treatment.
• Patients who use pacemakers or implantable cardioverter defibrillators.
• The patient did not complete the echocardiography, dynamic electrocardiogram, and polysomnography monitoring during hospitalization.

Sponsors & Collaborators

• Yihui Kong: lead

Study Sites (1)

Yihui Kong

Harbin, Heilongjiang, 150000, China

RECRUITING

MeSH Terms

Conditions

Heart Failure; Sleep Apnea Syndromes; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yihui Kong, M.D.

CONTACT

85555672; kongyihui@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 7, 2023
• Study Start: June 28, 2023
• Primary Completion: January 1, 2024
• Study Completion: April 30, 2024
• Last Updated: June 29, 2023

Record last verified: 2023-05

Locations

CN (1)