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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05892172
Other study ID # 2021020707
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 28, 2023
Est. completion date April 30, 2024

Study information

Verified date May 2023
Source First Affiliated Hospital of Harbin Medical University
Contact Yihui Kong, M.D.
Phone 85555672
Email kongyihui@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date April 30, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Yihui Kong Harbin Heilongjiang

Sponsors (1)

Lead Sponsor Collaborator
Yihui Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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