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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 : Terminated (Philips Global Field Safety Notice for PAP Devices & Ventilators)
First Posted : May 24, 2010
Last Update Posted : July 15, 2021
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Philips Respironics
Information provided by (Responsible Party):
Douglas Bradley, Toronto Rehabilitation Institute

Tracking Information
First Submitted Date  ICMJE April 26, 2010
First Posted Date  ICMJE May 24, 2010
Last Update Posted Date July 15, 2021
Study Start Date  ICMJE May 2010
Actual Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2010)
The time to the composite outcome of death or first hospital admission for a cardiovascular cause. [ Time Frame: The expected timeline is five years ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2010)
  • Time to death from any cause [ Time Frame: The expected timeline 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 is expected to be 5 years ]
  • Number of days alive not hospitalized [ Time Frame: Time until death or 540 primary endpoints achieved ]
    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 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 ]
  • 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: Changes from baseline will be assessed at each visit ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Apnea
  • Heart Failure
Intervention  ICMJE Device: Adaptive Servo Ventilation
BiPAP autoSV ADVANCED device worn nightly during sleep
Other Names:
  • BiPAP autoSV ADVANCED
  • ASV
  • Respironics
Study Arms  ICMJE
  • 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
    Intervention: Device: Adaptive Servo Ventilation
Publications * Perger E, Inami T, Lyons OD, Alshaer H, Smith S, Floras JS, Logan AG, Arzt M, Duran Cantolla J, Delgado D, Fitzpatrick M, Fleetham J, Kasai T, Kimoff RJ, Leung RST, Lorenzi Filho G, Mayer P, Mielniczuk L, Morrison DL, Parati G, Parthasarathy S, Redolfi S, Ryan CM, Series F, Tomlinson GA, Woo A, Bradley TD; ADVENT-HF Investigators. Distinct Patterns of Hyperpnea During Cheyne-Stokes Respiration: Implication for Cardiac Function in Patients With Heart Failure. J Clin Sleep Med. 2017 Nov 15;13(11):1235-1241. doi: 10.5664/jcsm.6788. Erratum in: J Clin Sleep Med. 2018 Apr 15;14(4):703.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 9, 2021)
732
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2010)
860
Actual Study Completion Date  ICMJE June 15, 2021
Actual Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American Heart Association Stage B-D Heart failure due to ischemic, idiopathic or hypertensive causes, present for at least 3 months
  • Left Ventricular Ejection Fraction ≤ 45 %
  • Optimal medical therapy for heart failure
  • No change in active cardiac medications for 2 weeks prior to randomization, beta-blockers must be started 3 months prior to randomization
  • Sleep apnea with an AHI ≥ 15. Subjects with obstructive sleep apnea must also have an Epworth Sleepiness Scale score of ≤ 10 and no or mild daytime sleepiness
  • Written informed consent

Exclusion Criteria:

  • Heart failure due to primary valvular heart disease
  • Presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease
  • Hypertrophic obstructive or restrictive or post partum cardiomyopathy
  • Exercise capacity limited by class IV angina pectoris
  • Acute MI, cardiac surgery, PCI, AICD, or CRT within 3 months of randomization
  • Active myocarditis
  • Planned AICD or CRT
  • Presence of a left-ventricular assist device
  • Transplanted heart or expected to receive a transplanted heart within the next 6 months
  • Pregnancy
  • Current use of ASV or CPAP or mandibular advancement device for treatment of sleep apnea or treated with any investigational therapy during the last 4 weeks (including approved therapies being used in unapproved indications)
  • A clinical history that would interfere with the objectives of this study or that would in the investigator's opinion preclude safe conclusion of the study
  • Any other medical, social, or geographical factor, which would make it unlikely that the patient will comply with the study procedures (e.g. alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or history of non-compliance)
  • Any contraindication to ASV therapy as detailed in the device provider manual
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Canada,   France,   Germany,   Italy,   Japan,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01128816
Other Study ID Numbers  ICMJE ADVENT-HF trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Douglas Bradley, Toronto Rehabilitation Institute
Study Sponsor  ICMJE Toronto Rehabilitation Institute
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Philips Respironics
Investigators  ICMJE
Study Chair: Douglas Bradley, M.D. Toronto Rehabilitation Institute
PRS Account Toronto Rehabilitation Institute
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP