Chronic Heart FailureNCT05332223
The Epidemiology of Sleep Disordered Breathing in Patients With Congestive Heart Failure
An observational study of Chronic Heart Failure and Sleep Disorder, run by Ministry of Health, Malaysia at 1 site in Malaysia.
Trial summary
This research will be one of the first hospital-based studies to comprehensively evaluate the epidemiological characteristics of sleep disordered breathing (SDB) in patients with Congestive Heart Failure (CHF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Sleep Disorder
- What is being tested?
- Full Polysomnography
- How many people
- 116 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Apr 2022to 31 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive adult patients under follow-up in Heart Failure Clinic, Hospital Taiping during the period 1 April 2022 - 31 December 2024
Who may be able to join
- All patients with CHF regardless of LVEF Participants need to be older than 18 years old and is able to understand study information and give informed consent
Who cannot join
- Patients who had been diagnosed with SDB or is treated with any form of Positive Airway Pressure (PAP) therapy prior to this will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Epidemiological Characteristics of Sleep Disordered Breathing in Patients With Reduced or Preserved Ejection Fraction Congestive Heart Failure
This research will be one of the first hospital-based studies to comprehensively evaluate the epidemiological characteristics of sleep disordered breathing (SDB) in patients with Congestive Heart Failure (CHF). This prospective, observational cohort, single center study will include all consecutive CHF outpatients from the specialized heart failure clinic in Medical Department, Hospital Taiping, Malaysia irrespective of preserved or depressed Left Ventricular Ejection Fraction (LVEF). All participants will be subjected to an attended in-laboratory polysomnogram (PSG). It is anticipated the frequency and types of SDB to be variable compared to western data as this subject remains understudied in the South East Asian population. This research utilizes PSG rather than Portable Sleep Testing (PST) as seen in preceding studies for the diagnosis of SDB to prevent underdiagnosing SDBs and clearly distinguishing Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA).
Read the detailed description
The epidemiology of SDB in CHF has not been studied in a South East Asian population. The results from studies conducted in USA and Europe on the prevalence of SDB in CHF may not be applicable to these patients for various reasons. Firstly, a diverse and multi -ethnic population in South East Asia may have an impact on the occurrence of SDB due to varying craniofacial morphological appearances, differences in levels of obesity and respiratory chemosensitivity. Additionally, the disparity in health services and the socio-economic differences between developed countries in the west and developing nations in South East Asia may have an impact on pharmacotherapy of CHF affecting the frequency and severity of SDB in these patients.
This research studies the epidemiological characteristics of SDB in non-selected, consecutive and consenting patients with CHF in the heart failure clinic as studying highly selected patients with clinical characteristics and risk factors of SBD may overestimate the prevalence. As patients with SDB in CHF may lack subjective EDS and assessment tools are unreliable in predicting SDB in CHF patients, the investigators wish to identify clinical predictors in this cohort of patients. It is anticipated there may be differences in this aspect when compared to patients in the western population and the investigators hope to obtain some understanding on the gender differences for SDB that has been reported in prior studies as well. The utility of attended in laboratory PSG as a diagnostic tool for all consecutive patients with CHF will prevent underestimation of AHI and clearly distinguish OSA and CSA based on standard definitions.
The prevalence of SDB in preserved ejection fraction CHF is understudied globally and the investigators wish to include preserved ejection fraction CHF patients apart from depressed ejection fraction CHF patients in this study. SDB presents as a treatment opportunity for patients with CHF but first the disorder has to be suspected and diagnosed. Initiation of nocturnal ventilation following diagnosis may treat the SDB and improve the prognosis of CHF.
- Conditions
- Chronic Heart Failure, Sleep Disorder
- Being tested
- Full Polysomnography
- Keywords
- Chronic Heart Failure, Sleep Disorder
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full PolysomnographyDiagnostic test
Overnight PSG will be conducted using Alice version 6 system (Respironics, Pittsburgh, PA, USA). During PSG, the following variables will be monitored and captured. Sleep staging using electroencephalogram (four channels: C3-A2, C4-A1, O1-A2, O2-A1), electrooculogram (two channels: LOC-A2, ROC-A1), electromyogram (two channels: submental and anterior tibialis muscles). Respiratory effort using inductive plethysmograph sensors to detect thoracoabdominal movements. Oro-nasal airflow using pressure flow transducer and thermistor. Oxygen saturation using pulse oximetry and cardiac rhythm using electrocardiography. Other parameters that will also be monitored includes body position, presence of snoring and end tidal CO2 (EtCO2) measurement to detect hypercapnia. The attended PSG will be conducted in the sleep laboratory in Respiratory Unit, Hospital Taiping
| Study group | Role | What they receive |
|---|---|---|
| Chronic Heart Failure Patients | All patients in our specialised heart failure clinic will be screened by the investigator/s. Receives: Diagnostic Test: Full Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Sleep Disordered Breathing
Present or Absent
Measured: through study completion, an average of 2 years
Type of Sleep Disordered Breathing
Obstructive or Central Sleep Apnoea
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start15 Apr 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ALBERT ANTHONY, Ministry of Health, Malaysia
- Investigators
- ALBERT IRUTHIARAJ L. ANTHONY, MBBS, Principal investigator, HOSPITAL TAIPING
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332223
- Sponsor's protocol ID
- NMRR ID-22-00210-Y9W (IIR)
- Status last verified
- Feb 2024
- First submitted
- 4 Apr 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arzt M, Young T, Finn L, Skatrud JB, Ryan CM, Newton GE, Mak S, Parker JD, Floras JS, Bradley TD. Sleepiness and sleep in patients with both systolic heart failure and obstructive sleep apnea. Arch Intern Med. 2006 Sep 18;166(16):1716-22. doi: 10.1001/archinte.166.16.1716.
PubMed 16983049Arzt M, Woehrle H, Oldenburg O, Graml A, Suling A, Erdmann E, Teschler H, Wegscheider K; SchlaHF Investigators. Prevalence and Predictors of Sleep-Disordered Breathing in Patients With Stable Chronic Heart Failure: The SchlaHF Registry. JACC Heart Fail. 2016 Feb;4(2):116-125. doi: 10.1016/j.jchf.2015.09.014. Epub 2015 Dec 9.
PubMed 26682790Collop NA, Anderson WM, Boehlecke B, Claman D, Goldberg R, Gottlieb DJ, Hudgel D, Sateia M, Schwab R; Portable Monitoring Task Force of the American Academy of Sleep Medicine. Clinical guidelines for the use of unattended portable monitors in the diagnosis of obstructive sleep apnea in adult patients. Portable Monitoring Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2007 Dec 15;3(7):737-47.
PubMed 18198809Chan J, Sanderson J, Chan W, Lai C, Choy D, Ho A, Leung R. Prevalence of sleep-disordered breathing in diastolic heart failure. Chest. 1997 Jun;111(6):1488-93. doi: 10.1378/chest.111.6.1488.
PubMed 9187161Joynt KE, Jha AK. Who has higher readmission rates for heart failure, and why? Implications for efforts to improve care using financial incentives. Circ Cardiovasc Qual Outcomes. 2011 Jan 1;4(1):53-9. doi: 10.1161/CIRCOUTCOMES.110.950964. Epub 2010 Dec 14.
PubMed 21156879Lourdesamy Anthony AI, Abdul Rani R. The epidemiological characteristics of sleep disordered breathing in congestive heart failure: A prospective, single centre study in Southeast Asia. J R Coll Physicians Edinb. 2024 Mar;54(1):18-25. doi: 10.1177/14782715241239704. Epub 2024 Mar 20.
PubMed 38509698
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiological Characteristics of Sleep Disordered Breathing in Patients With Reduced or Preserved Ejection Fraction Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT05332223
- Acronym / sponsor ID
- NMRR ID-22-00210-Y9W (IIR)
- Conditions
- Chronic Heart Failure, Sleep Disorder
- Keywords
- Chronic Heart Failure, Sleep Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Apr 2022 (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.
This research will be one of the first hospital-based studies to comprehensively evaluate the epidemiological characteristics of sleep disordered breathing (SDB) in patients with Congestive Heart Failure (CHF). This prospective, observational cohort, single center study will include all consecutive CHF outpatients from the specialized heart failure clinic in Medical Department, Hospital Taiping, Malaysia irrespective of preserved or depressed Left Ventricular Ejection Fraction (LVEF). All participants will be subjected to an attended in-laboratory polysomnogram (PSG). It is anticipated the frequency and types of SDB to be variable compared to western data as this subject remains understudied in the South East Asian population. This research utilizes PSG rather than Portable Sleep Testing (PST) as seen in preceding studies for the diagnosis of SDB to prevent underdiagnosing SDBs and clearly distinguishing Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA).
Detailed description
The epidemiology of SDB in CHF has not been studied in a South East Asian population. The results from studies conducted in USA and Europe on the prevalence of SDB in CHF may not be applicable to these patients for various reasons. Firstly, a diverse and multi -ethnic population in South East Asia may have an impact on the occurrence of SDB due to varying craniofacial morphological appearances, differences in levels of obesity and respiratory chemosensitivity. Additionally, the disparity in health services and the socio-economic differences between developed countries in the west and developing nations in South East Asia may have an impact on pharmacotherapy of CHF affecting the frequency and severity of SDB in these patients.
This research studies the epidemiological characteristics of SDB in non-selected, consecutive and consenting patients with CHF in the heart failure clinic as studying highly selected patients with clinical characteristics and risk factors of SBD may overestimate the prevalence. As patients with SDB in CHF may lack subjective EDS and assessment tools are unreliable in predicting SDB in CHF patients, the investigators wish to identify clinical predictors in this cohort of patients. It is anticipated there may be differences in this aspect when compared to patients in the western population and the investigators hope to obtain some understanding on the gender differences for SDB that has been reported in prior studies as well. The utility of attended in laboratory PSG as a diagnostic tool for all consecutive patients with CHF will prevent underestimation of AHI and clearly distinguish OSA and CSA based on standard definitions.
The prevalence of SDB in preserved ejection fraction CHF is understudied globally and the investigators wish to include preserved ejection fraction CHF patients apart from depressed ejection fraction CHF patients in this study. SDB presents as a treatment opportunity for patients with CHF but first the disorder has to be suspected and diagnosed. Initiation of nocturnal ventilation following diagnosis may treat the SDB and improve the prognosis of CHF.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Heart Failure Patients | – | Diagnostic Test: Full PolysomnographyAll patients in our specialised heart failure clinic will be screened by the investigator/s. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients under follow-up in Heart Failure Clinic, Hospital Taiping during the period 1 April 2022 - 31 December 2024
Key inclusion criteria (1 listed)
- All patients with CHF regardless of LVEF Participants need to be older than 18 years old and is able to understand study information and give informed consent
Key exclusion criteria (1 listed)
- Patients who had been diagnosed with SDB or is treated with any form of Positive Airway Pressure (PAP) therapy prior to this will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full PolysomnographyOvernight PSG will be conducted using Alice version 6 system (Respironics, Pittsburgh, PA, USA). During PSG, the following variables will be monitored and captured. Sleep staging using electroencephalogram (four channels: C3-A2, C4-A1, O1-A2, O2-A1), electrooculogram (two channels: LOC-A2, ROC-A1), electromyogram (two channels: submental and anterior tibialis muscles). Respiratory effort using inductive plethysmograph sensors to detect thoracoabdominal movements. Oro-nasal airflow using pressure flow transducer and thermistor. Oxygen saturation using pulse oximetry and cardiac rhythm using electrocardiography. Other parameters that will also be monitored includes body position, presence of snoring and end tidal CO2 (EtCO2) measurement to detect hypercapnia. The attended PSG will be conducted in the sleep laboratory in Respiratory Unit, Hospital Taiping | Diagnostic test | Chronic Heart Failure Patients |
Primary outcome
Presence of Sleep Disordered Breathing
Time frame: through study completion, an average of 2 years
Present or Absent
Type of Sleep Disordered Breathing
Time frame: through study completion, an average of 2 years
Obstructive or Central Sleep Apnoea
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 16983049Arzt M, Young T, Finn L, Skatrud JB, Ryan CM, Newton GE, Mak S, Parker JD, Floras JS, Bradley TD. Sleepiness and sleep in patients with both systolic heart failure and obstructive sleep apnea. Arch Intern Med. 2006 Sep 18;166(16):1716-22. doi: 10.1001/archinte.166.16.1716.
- Background: PubMed 26682790Arzt M, Woehrle H, Oldenburg O, Graml A, Suling A, Erdmann E, Teschler H, Wegscheider K; SchlaHF Investigators. Prevalence and Predictors of Sleep-Disordered Breathing in Patients With Stable Chronic Heart Failure: The SchlaHF Registry. JACC Heart Fail. 2016 Feb;4(2):116-125. doi: 10.1016/j.jchf.2015.09.014. Epub 2015 Dec 9.
- Background: PubMed 18198809Collop NA, Anderson WM, Boehlecke B, Claman D, Goldberg R, Gottlieb DJ, Hudgel D, Sateia M, Schwab R; Portable Monitoring Task Force of the American Academy of Sleep Medicine. Clinical guidelines for the use of unattended portable monitors in the diagnosis of obstructive sleep apnea in adult patients. Portable Monitoring Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2007 Dec 15;3(7):737-47.
- Background: PubMed 9187161Chan J, Sanderson J, Chan W, Lai C, Choy D, Ho A, Leung R. Prevalence of sleep-disordered breathing in diastolic heart failure. Chest. 1997 Jun;111(6):1488-93. doi: 10.1378/chest.111.6.1488.
- Results publication: PubMed 21156879Joynt KE, Jha AK. Who has higher readmission rates for heart failure, and why? Implications for efforts to improve care using financial incentives. Circ Cardiovasc Qual Outcomes. 2011 Jan 1;4(1):53-9. doi: 10.1161/CIRCOUTCOMES.110.950964. Epub 2010 Dec 14.
- Derived from this study: PubMed 38509698Lourdesamy Anthony AI, Abdul Rani R. The epidemiological characteristics of sleep disordered breathing in congestive heart failure: A prospective, single centre study in Southeast Asia. J R Coll Physicians Edinb. 2024 Mar;54(1):18-25. doi: 10.1177/14782715241239704. Epub 2024 Mar 20.
- Individual participant dataSharing planned: No
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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.
ALBERT IRUTHIARAJ L. ANTHONY, MBBS principal investigator
HOSPITAL TAIPING
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 Chronic Heart Failure and Sleep Disorder, run by Ministry of Health, Malaysia at 1 site in Malaysia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Feb 2024. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Sleep Disordered Breathing (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05332223, which also lists 6 linked publications.
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 15 Feb 2024.