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

NCT06313840 | Completed

• 1 other identifier: CIP3125
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure; Central Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Prevalence of CSA in tested HFrEF/HFmrEF patients

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• 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

Study Arms (3)

Case group - subjects with central sleep apnea

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

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

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

Patients that do not meet criteria for CSA or no SDB

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients 50 years or older with HFrEF/HFmrEF and no history of sleep disordered breathing (SDB) and not tested for SDB within the prior year will be tested for sleep apnea using a home sleep apnea test (WatchPAT device).

You may qualify if:

• Diagnosed with heart failure with reduced or mildly reduced left ventricular ejection fraction (LVEF \<50%) at least 3 months prior to enrollment
• New York Heart Association (NYHA) functional class II-IV
• 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
• Age 50 years or older
• Signed Institutional Review Board (IRB) or Ethics Committee (EC) approved informed consent
• In the opinion of the investigator, subject is willing and able to comply with the protocol, including the cognitive function assessment

You may not qualify if:

• Hospitalized for heart failure-related complications in the last 4 weeks
• History of SDB and/or prior or ongoing treatment for SDB or tested for SDB within the prior year
• 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
• Per the patient and investigator, willing and able to postpone CSA treatment until completion of the study assessment visit (Visit 3)
• Color blindness
• Currently taking opioids
• Has taken medications for memory/cognition within the last 3 months (including but not limited to cholinesterase inhibitors and/or glutamate regulators)
• Cerebrovascular accident (stroke or transient ischemic attack) in the last 12 months
• 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.

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (1)

Szpital Uniwersytecki we Wrocławiu

Wroclaw, Poland

Location

MeSH Terms

Conditions

Heart Failure; Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kathy McPherson

  ZOLL Respciardia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 15, 2024
• Study Start: August 21, 2023
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

PL (1)