Status:
NOT_YET_RECRUITING
Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment
Lead Sponsor:
VA Office of Research and Development
Conditions:
Sleep Disordered Breathing
Able Bodied
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 mo...
Detailed Description
The objective in this project is to test mechanistic pathways to inform future clinical studies investigating the potential treatment of central sleep apnea (CSA) in Veterans with heart failure and re...
Eligibility Criteria
Inclusion
- 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
- less than 18 years old
- pregnant or breastfeeding females
- moderate or severe obstructive or restrictive lung disease, including supplemental o2 use
- current treatment for CSA, including any form of 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)
- PAP-emergent central sleep apnea
- Lack of PAP acceptance/adherence after a one-week home PAP trial after enrollment.
- Additional Trazodone Exclusions:
- Prolonged QT on baseline ECG, using medications that inhibit CYP3A4
- Patients with severe renal impairment (GFR \< 20ml/min/1.73m2) or end-stage renal disease
Key Trial Info
Start Date :
October 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07210606
Start Date
October 1 2026
End Date
December 31 2030
Last Update
January 7 2026
Active Locations (1)
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1
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, United States, 48201-1916