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 : Active, not recruiting
First Posted : May 24, 2010
Last Update Posted : April 1, 2021
|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 :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2021|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128816
|Study Chair:||Douglas Bradley, M.D.||Toronto Rehabilitation Institute|