The Epidemiology of Sleep Disordered Breathing in Patients With Congestive Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

The Epidemiological Characteristics of Sleep Disordered Breathing in Patients With Reduced or Preserved Ejection Fraction Congestive Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05332223
• Other study ID #: NMRR ID-22-00210-Y9W (IIR)
• Status: Completed
• Start date: April 15, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Ministry of Health, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Parasomnias
• Sleep Apnea Syndromes
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Diagnostic Test:
• Full Polysomnography
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

Locations

Country	Name	City	State
Malaysia	Hospital Taiping	Taiping	Perak

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (5)

Arzt 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. — View Citation

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. — View Citation

Chan 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. — View Citation

Collop 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. — View Citation

Joynt 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Sleep Disordered Breathing	Present or Absent	through study completion, an average of 2 years
Primary	Type of Sleep Disordered Breathing	Obstructive or Central Sleep Apnoea	through study completion, an average of 2 years