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

Heart Failure Clinical Trial

— COG01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313840
• Other study ID #: CIP3125
• Status: Recruiting
• Start date: August 21, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: Zoll Medical Corporation
• Contact: Tsiry Rabemahefa
• Phone: 218-329-7356
• Email: tsiry.rabemahefa[@]zoll.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Heart Failure
• Sleep Apnea Syndromes
• Sleep Apnea, Central

Locations

Country	Name	City	State
Poland	Przychodnia na Teczowej	Wroclaw
Poland	Szpital Uniwersytecki we Wroclawiu	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in cognitive function scores between the HFrEF/HFmrEF CSA and no SDB groups using the CANTAB assessment.	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).	Through study completion, an average of 1 year