Heart FailureNCT05892172
Heart Failure and Sleep Disordered Breathing
An observational study of Heart Failure, run by Yihui Kong at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Heart failure patients hospitalized in the Department of Cardiology of the First Affiliated Hospital of Harbin Medical University
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yihui Kong
Harbin, Heilongjiang, 150000
Yihui Kong, M.D., 85555672, kongyihui@126.com
About this study
Official title: 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.
- Conditions
- Heart Failure
- Keywords
- sleep disordered breathing, arrhythmia, heart rate variability
- Medical subject headings
- Heart Failure, Sleep Apnea Syndromes, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start28 Jun 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yihui Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yihui Kong, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892172
- Sponsor's protocol ID
- 2021020707
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Arrhythmia and Heart Rate Variability in Patients With Heart Failure and Sleep Disordered Breathing
- ClinicalTrials.gov ID
- NCT05892172
- Acronym / sponsor ID
- 2021020707
- Conditions
- Heart Failure
- Keywords
- sleep disordered breathing, arrhythmia, heart rate variability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yihui KongUniversity, hospital or other
- Study start
- 28 Jun 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients hospitalized in the Department of Cardiology of the First Affiliated Hospital of Harbin Medical University
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Yihui Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yihui Kong, M.D. (85555672, kongyihui@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart failure and sleep apnea (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023; AzTrials last refreshed its copy on 27 Oct 2026.