ADVENT-HF
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Objectives

  • The main objective of this study is to evaluate the effects of ASV on mortality, CV hospitalizations, new onset atrial fibrillation/flutter requiring anticoagulation but not hospitalization, or delivery of an appropriate shock from an ICD, not resulting in hospitalization. Secondary objectives include the evaluation of ASV on mortality alone, left-ventricular (LV) remodeling, changes in plasma levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP), exercise capacity and quality of life.

Study Type and Phase

  • Interventional
  • Phase 4​

Trial design

  • Multi-centre, randomized, parallel-group, open label

Indication

  • Heart failure patients with obstructive sleep apnea (OSA) or central sleep apnea (CSA)

Target population

  • Patients with American Heart Association Stages B, C, and D heart failure, left-venticular ejection fraction (LVEF) ≤ 45%, on optimal medical therapy for heart failure; OSA or CSA with an apnea hypopnea index (AHI) ≥ 15.

Study Arms

  • No Intervention: Standard HF therapy Subjects will receive optimal standard therapy for heart failure conforming to national guidelines as determined by the referring cardiologist
  • Active Comparator: Standard therapy for HF + ASV Subjects will receive treatment with ASV in addition to optimal standard therapy for heart failure conforming to national guidelines, as determined by the referring cardiologist
    Intervention: Device: ASV

Intervention

​Device: Philips Respironics Adaptive Servo Ventilation BiPAP autoSV ADVANCED device worn nightly during sleep
Other Names:
  • Philips Respironics BiPAP autoSV ADVANCED
  • Philips Respironics ASV

Primary Outcome Measures 

  • The time to the composite outcome of death or first CV hospital admission or new onset atrial fibrillation/flutter requiring anti-coagulation but not hospitalization or delivery of an appropriate shock from an ICD not resulting in hospitalization. 
  • The study is designed to capture 540 primary endpoints. 

Secondary Outcome Measures

  • Time to death from any cause 
  • Number of cardiovascular hospitalizations per follow-up
  • Number of days alive not hospitalized.  The number of days the patient is hospitalized are subtracted from the total number of days in the study from randomization
  • Changes in LV function will be assessed by echocardiography at 6 months post randomization
  • Changes in plasma NT-proBNP levels will be assessed at baseline and at 6 months post randomization
  • Cardiac resynchronization therapy or defibrillator implantations.  The average number of days from randomization to the first occurrence of CRT or defibrillator implantation
  • Changes in the 6-minute walk distance between baseline and 6 month visit
  • Changes in the New York Heart Association classification and American Heart Association Stages of Heart Failure
  • Changes in apnea/hypopnea index
  • Changes in quality of life Minnesota living with Heart Failure Questionnaire and Epworth Sleepiness Scale

Email

info@ADVENT-HF.com

Contact

​Toronto Rehabilitation Institute, University Health Network
550 University Ave, Toronto, ON, M5G 2A2
​Canada

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  • Home
  • About
  • Study details
  • Locations
  • Contact
  • Publications