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Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment

RecruitingPhase 4Ages 18 Years - anyAllVA Office of Research and Development
NCT07210606 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Central sleep apnea (CSA) is common in patients with heart failure and those using opioid analgesics. Unfortunately, effective treatment of central apnea remains elusive, pressure therapy given the modest efficiency of positive airway pressure therapy. The focus of this proposal is to identify mechanistic pathways to guide future therapeutic interventions for central sleep apnea based on the strong premise that multi-modality therapy will normalize respiration and hence mitigate adverse long-term consequences of CSA. The investigators' proposed studies will test combination therapies, including positive airway pressure (PAP) plus a pharmacological agent who have heart failure or are using opioid analgesics. The investigators anticipate that findings will inform future clinical trials to improve care and quality of life among Veterans suffering from central sleep apnea, which remains diff

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📋 Eligibility rules (as published)
Inclusion Criteria: * Men and women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)\>15/hour with CAHI\>5/hour, will be included with the experiments * Those with chronic, stable heart failure with reduced ejection fraction, receiving stable optimized guideline-based therapy and no hospitalizations or change in the medical regimen for the past 90 days before enrollment Exclusion Criteria: * Pregnant or breastfeeding females * Moderate or severe obstructive or restrictive lung disease, including supplemental oxygen (O2) use * Current treatment for central sleep apnea (CSA), including any form of positive airway pressure (PAP) in the past three months, or phrenic nerve situation * Too ill to engage in the study procedures, inability to provide consent for participation * A history of cardiac arrhythmia * Alcohol or substance abuse (less than 90 days sobriety) or current participation in a treatment program * Depression or a history of suicidality * Severe insomnia (ISI\>21) or reported short sleep duration (\<6 hours) * Positive airway pressure (PAP)-emergent central sleep apnea * Lack of positive airway pressure (PAP) acceptance/adherence after a one-week home PAP trial after enrollment Additional Trazodone Exclusions: * Prolonged QT on baseline electrocardiogram (ECG), using medications that inhibit CYP3A4 * Patients with severe renal impairment (glomerular filtration rate (GFR) \< 20 milliliters per minute/1.73 square meters) or end-stage renal disease
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What it tests

  • Trazodone + positive airway pressure (PAP) therapy
  • Oxygen + positive airway pressure (PAP) therapy
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Where

1 site
John D. Dingell VA Medical Center, Detroit, MI
Detroit, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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