Central Sleep Apnea Prevalence and Impact on Cognitive Function in Patients with Heart Failure with Reduced or Mildly Reduced Left Ventricular Ejection Fraction

Completed

• Conditions: Central Sleep Apnea; Heart Failure

• Registration Number: NCT06313840
• Lead Sponsor: Zoll Medical Corporation

Brief Summary

Study to assess the prevalence of central sleep apnea in patients with heart failure with reduced or mildly reduced left ventricular ejection fraction (LVEF \<50%) followed by case-control study to assess the link between central sleep apnea and cognitive function

Detailed Description

The study will be conducted in two phases: prevalence phase and cognitive phase.

Adult patients with HFrEF/HFmrEF will perform a home sleep apnea test (HSAT). Patients will be assigned to one of the following groups based on their sleep study results: CSA, other SDB, or no SDB. This constitutes the prevalence phase of the study.

The cognitive phase of the study is a case-control study that will assess cognitive function in 20 patients in the CSA group (case) and 20 patients in the no SDB group (control).

Study Timeline

• Study Start: 2023-08-21
• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-15
• Primary Completion: 2025-01-20
• Study Completion: 2025-01-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Diagnosed with heart failure with reduced or mildly reduced left ventricular ejection fraction (LVEF <50%) at least 3 months prior to enrollment
2. New York Heart Association (NYHA) functional class II-IV
3. Treated and optimized on heart failure guideline directed medical therapy as indicated for at least 4 weeks, including angiotensin receptor-neprilysin inhibitors (ARNI) (or angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blocker (ARB)), aldosterone receptor antagonists, beta-blockers and/or sodium glucose co-transporter 2 (SGLT-2) antagonists
4. Age 50 years or older
5. Signed Institutional Review Board (IRB) or Ethics Committee (EC) approved informed consent
6. In the opinion of the investigator, subject is willing and able to comply with the protocol, including the cognitive function assessment

Prevalence Phase

Exclusion Criteria

1. Hospitalized for heart failure-related complications in the last 4 weeks
2. History of SDB and/or prior or ongoing treatment for SDB or tested for SDB within the prior year

Cognitive Phase Inclusion Criteria:

1. AHI ≥ 15 events per hour and CAHI ≥ 50% of total AHI (Case group) or AHI < 5 events per hour (Control group) based on the baseline HSAT
2. Per the patient and investigator, willing and able to postpone CSA treatment until completion of the study assessment visit (Visit 3)

Cognitive Phase Exclusion Criteria:

1. Color blindness
2. Currently taking opioids
3. Has taken medications for memory/cognition within the last 3 months (including but not limited to cholinesterase inhibitors and/or glutamate regulators)
4. Cerebrovascular accident (stroke or transient ischemic attack) in the last 12 months
5. Diagnosed with neurological disease including but not limited to history of seizures, meningitis, traumatic brain injury, amyotrophic lateral sclerosis, multiple sclerosis, attention-deficit/hyperactivity disorder (ADHD) or autism.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of CSA in tested HFrEF/HFmrEF patients	Through study completion, an average of 1 year	Determine the prevalence of CSA in a contemporary population of HFrEF/HFmrEF patients completing a Home Sleep Apnea Test (using a WatchPAT device) during the prevalence phase of the study.

Secondary Outcome Measures

Name	Time	Method
Difference in cognitive function scores between the HFrEF/HFmrEF CSA and no SDB groups using the CANTAB assessment.	Through study completion, an average of 1 year	Evaluate differences in cognitive function between adult patients with heart failure with reduced or mildly reduced left ventricular ejection fraction (HFrEF/HFmrEF) (LVEF \<50%) and central sleep apnea (CSA) versus patients with HFrEF/HFmrEF and no sleep disordered breathing (SDB) using a battery of assessments from the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Trial Locations

Locations (1)

Szpital Uniwersytecki we Wrocławiu; 🇵🇱 Wrocław, Poland