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Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure (ADVENT-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Toronto Rehabilitation Institute
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Philips Respironics
Information provided by (Responsible Party):
Douglas Bradley, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT01128816
First received: April 26, 2010
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Sleep Apnea
Heart Failure
Device: Adaptive Servo Ventilation
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Toronto Rehabilitation Institute:

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. [ 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 860
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)
Arms Assigned Interventions
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
Other Names:
  • BiPAP autoSV ADVANCED
  • ASV
  • Respironics

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128816

Contacts
Contact: Janis A Andrews 416-597-3422 ext 7805 janis.andrews@uhn.ca

  Show 36 Study Locations
Sponsors and Collaborators
Toronto Rehabilitation Institute
Canadian Institutes of Health Research (CIHR)
Philips Respironics
Investigators
Study Chair: Douglas Bradley, M.D. Toronto Rehabilitation Institute
  More Information

No publications provided

Responsible Party: Douglas Bradley, Study Chairman, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT01128816     History of Changes
Other Study ID Numbers: ADVENT-HF trial
Study First Received: April 26, 2010
Last Updated: October 6, 2014
Health Authority: Canada: Ethics Review Committee
Spain: Comité Ético de Investigación Clínica
United Kingdom: Research Ethics Committee
Germany: Ethics Commission
United States: Institutional Review Board
Italy: Ethics Committee

Keywords provided by Toronto Rehabilitation Institute:
obstructive sleep apnea
central sleep apnea
heart failure
congestive heart failure
adaptive servo ventilation
ASV

Additional relevant MeSH terms:
Apnea
Heart Failure
Sleep Apnea Syndromes
Cardiovascular Diseases
Dyssomnias
Heart Diseases
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 27, 2014