Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure (ADVENT-HF)
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|ClinicalTrials.gov Identifier: NCT01128816|
Recruitment Status : Recruiting
First Posted : May 24, 2010
Last Update Posted : December 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Heart Failure||Device: Adaptive Servo Ventilation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||860 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
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
- 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 study follow-up period is five years ]The study will end once 540 primary endpoints have occurred. The maximum follow-up period for all randomized subjects is 5 years.
- Time to death from any cause [ Time Frame: The expected study follow-up period is 5 years ]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 time of follow-up is expected to be 5 years ]
- Number of days alive not hospitalized [ Time Frame: Time from randomization to censoring (death, primary event or end of study) ]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 ]Changes in LV function will be assessed by echocardiography at baseline and at 6 months post randomization
- Changes in plasma BNP levels [ Time Frame: 6 months from randomization ]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 ]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 ]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 ]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 ]
- Changes in Quality of life assessments [ Time Frame: Assessments made at baseline, 1, 6, 12 and every 6 months thereafter ]Minnesota living with Heart Failure Questionnaire and Epworth Sleepiness Scale will be used. Scores will be compared between the 2 groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128816
|Contact: Maggie Szeto||416-597-3422 ext 7721||Maggie.Szeto@uhn.ca|
Show 55 Study Locations
|Study Chair:||Douglas Bradley, M.D.||Toronto Rehabilitation Institute|