Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure (ADVENT-HF)
Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of hospitalizations and death. It is not known however whether treating SA reduces these risks. This study is looking at whether a respiratory device known as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations and death in subjects with HF and SA. Study subjects will randomly receive either their regular medications OR their regular medications plus ASV. They will be followed for approximately 5 years and information relevant to their health will be collected and compared.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-Centre, Randomized Study to Assess the Effects of Adaptive Servo Ventilation (ASV) on Survival and Frequency of Hospital Admissions in Patients With Heart Failure (HF) and Sleep Apnea (SA)-The ADVENT-HF Trial|
- 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. [ Time Frame: The expected timeline is five years ] [ Designated as safety issue: Yes ]The study will end once 540 primary endpoints have occurred. Enrollment is expected to take 3 years with a minimum follow-up of 2 years thus the last patient is expected to complete the study by April 2015.
- Time to death from any cause [ Time Frame: The expected timeline is 5 years ] [ Designated as safety issue: Yes ]The study will end once 540 primary endpoints have occurred.
- Number of cardiovascular hospitalizations per year of follow-up [ Time Frame: The minimum time of follow-up is expected to be 2 years. The maximum is expected to be 5 years ] [ Designated as safety issue: Yes ]
- Number of days alive not hospitalized [ Time Frame: Time from randomization to censoring (death, primary event or end of study) ] [ Designated as safety issue: Yes ]The number of days the patient is hospitalized are subtracted from the total number of days in the study from randomization. This number will be compared between the 2 groups.
- Changes in left ventricular function [ Time Frame: 6 months from randomization ] [ Designated as safety issue: No ]Changes in LV function will be assessed by echocardiography at 6 months post randomization
- Changes in plasma BNP levels [ Time Frame: 6 months from randomization ] [ Designated as safety issue: No ]Changes in plasma NT-proBNP levels will be assessed at baseline and at 6 months post randomization
- Cardiac resynchronization therapy or defibrillator implantations [ Time Frame: Average number of days until first cardiac resynchronization or first defibrillator implantation ] [ Designated as safety issue: No ]The average number of days from randomization to the first occurrence of CRT or defibrillator implantation will be calculated and compared between each treatment arm.
- Changes in 6 minute walk test distance [ Time Frame: 6 months from randomization ] [ Designated as safety issue: No ]Changes in the 6-minute walk distance between baseline and 6 months will be compared between the 2 groups
- Percentage of patients with changes in stages of heart failure and functional class [ Time Frame: Values obtained at study termination will be compared to those obtained at randomization ] [ Designated as safety issue: No ]New York Heart Association classification and AHA/ACC Stages of Heart Failure will be assessed at each visit.
- Changes in apnea/hypopnea index [ Time Frame: 1 month from randomization ] [ Designated as safety issue: No ]
- Changes in Quality of life assessments [ Time Frame: Assessments made at baseline, 1, 6, 12 and every 6 months thereafter ] [ Designated as safety issue: No ]Minnesota living with Heart Failure Questionnaire and Epworth Sleepiness Scale will be used. Scores will be compared between the 2 groups.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
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 Adaptive Servo Ventilation in addition to optimal standard therapy for heart failure conforming to national guidelines, as determined by the referring cardiologist
Device: Adaptive Servo Ventilation
BiPAP autoSV ADVANCED device worn nightly during sleep
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128816
|Contact: Janis A Andrews||416-597-3422 ext firstname.lastname@example.org|
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|Study Chair:||Douglas Bradley, M.D.||Toronto Rehabilitation Institute|