Central Sleep Apnea, Heart Failure
Conditions
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).
Interventions
None listed
Sponsors
Zoll Medical Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Poland
Outcome results
None listed