Central Sleep Apnea Prevalence and Impact on Cognitive Function in Patients with Heart Failure with Reduced or Mildly Reduced Left Ventricular Ejection Fraction (COG01)

ZOLL Medical

Status: Completed

Conditions: Central Sleep Apnea; Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT06313840

CIP3125

Details and patient eligibility

About

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

Full 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).

Enrollment: 200 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Prevalence Phase 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.

Trial design

200 participants in 3 patient groups

Case group - subjects with central sleep apnea

Description:

Patients with moderate to severe CSA defined by an apnea hypopnea index (AHI) ≥ 15 events per hour and a central apnea hypopnea index (CAHI) ≥ 50% of total AHI.

Control group - subjects with no sleep disordered breathing

Description:

Patients with no SDB defined by an AHI \< 5 events per hour.

Other SDB group - subjects with other forms of sleep disordered breathing

Description:

Patients that do not meet criteria for CSA or no SDB