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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026510
Receipt No. R000030189
Scientific Title A Multi-Centre, Randomized Study to Assess the Effects of Adaptive Servo Ventilation (ASV) on Survival and frequency of Cardiovascular (CV) Hospital Admissions in Patients with Heart failure (HF) and Sleep Apnea (SA)- The ADVENT-HF Trial.
Date of disclosure of the study information 2017/04/01
Last modified on 2018/03/13

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Basic information
Public title A Multi-Centre, Randomized Study to Assess the Effects of Adaptive Servo Ventilation (ASV) on Survival and frequency of Cardiovascular (CV) Hospital Admissions in Patients with Heart failure (HF) and Sleep Apnea (SA)- The ADVENT-HF Trial.
Acronym The ADVENT-HF Trial
Scientific Title A Multi-Centre, Randomized Study to Assess the Effects of Adaptive Servo Ventilation (ASV) on Survival and frequency of Cardiovascular (CV) Hospital Admissions in Patients with Heart failure (HF) and Sleep Apnea (SA)- The ADVENT-HF Trial.
Scientific Title:Acronym The ADVENT-HF Trial
Region
Japan North America South America
Europe

Condition
Condition Patients With Heart Failure and Sleep Apnea
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 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.
Key secondary outcomes Time to death from any cause
Number of cardiovascular hospitalizations per year of follow-up
Number of days alive not hospitalized
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 LV function will be assessed by echocardiography at 6 months post randomization
Changes in plasma BNP levels
Changes in plasma NT-proBNP levels will be assessed at baseline and at 6 months post randomization
Cardiac resynchronization therapy or defibrillator implantations
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
Percentage of patients with changes in stages of heart failure and functional class
Changes in apnea/hypopnea index
Changes in Quality of life assessments

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 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



Interventions/Control_2 No Intervention: Standard HF therapy
Subjects will receive optimal standard therapy for heart failure conforming to national guidelines as determined by the referring cardiologist
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria American Heart Association Stage B-D Heart failure due to ischemic, idiopathic or hypertensive causes, present for at least 3 months
1.Left Ventricular Ejection Fraction less than 45 percent
2.Optimal medical therapy for heart failure
3.No change in active cardiac medications for 2 weeks prior to randomization, beta-blockers must be started 3 months prior to randomization
4.Sleep apnea with an AHI more than 15. Subjects with obstructive sleep apnea must also have an Epworth Sleepiness Scale score of less than 10 and no or mild daytime sleepiness
5.Written informed consent
Key exclusion criteria Heart failure due to primary valvular heart disease
1.Presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease
2.Hypertrophic obstructive or restrictive or post partum cardiomyopathy
3.Exercise capacity limited by class IV angina pectoris
4.Acute MI, cardiac surgery, PCI, AICD, or CRT within 3 months of randomization
5.Active myocarditis
6.Planned AICD or CRT
7.Presence of a left-ventricular assist device
8.Transplanted heart or expected to receive a transplanted heart within the next 6 months
9.Pregnancy
10.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)
11.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
12.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)
13.Any contraindication to ASV therapy as detailed in the device provider manual
Target sample size 860

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Douglas Bradley, M.D.
Organization Toronto Rehabilitation Institute
Division name Toronto Rehabilitation Institute
Zip code
Address aa
TEL 416-597-3422
Email Novlette.Fraser@uhn.ca

Public contact
Name of contact person
1st name
Middle name
Last name Takatoshi Kasai
Organization Juntendo Univ
Division name Dep Cardiology
Zip code
Address Bunkyo-ku Hongo 2-1-1
TEL 03-3813-3111
Homepage URL https://www.juntendo.ac.jp/hospital/
Email takatoshi.kasai@gmail.com

Sponsor
Institute Toronto Rehabilitation Institute
Institute
Department

Funding Source
Organization Toronto Rehabilitation Institute
Canadian Institutes of Health Research (CIHR) Philips Respironics
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT01128816
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2010 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 11 Day
Last modified on
2018 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030189

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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