UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026510 |
|---|---|
| Receipt number | 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 | 2022/04/08 18:35:34 |
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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 | Douglas |
| Middle name | |
| Last name | Bradley |
Organization
Toronto Rehabilitation Institute
Division name
Toronto Rehabilitation Institute
Zip code
M5G2C4
Address
aa
TEL
416-597-3422
Novlette.Fraser@uhn.ca
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo Univ
Division name
Dep Cardiology
Zip code
113-8421
Address
Bunkyo-ku Hongo 2-1-1
TEL
03-3813-3111
Homepage URL
https://www.juntendo.ac.jp/hospital/
takatoshi.kasai@gmail.com
Sponsor or person
Institute
Toronto Rehabilitation Institute
Institute
Department
Personal name
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
aa
Address
aa
Tel
aa
aa@juntendo.ac.jp
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
https://onlinelibrary.wiley.com/doi/epdf/10.1002/ejhf.790
Publication of results
Unpublished
Result
URL related to results and publications
Not released yet
Number of participants that the trial has enrolled
0
Results
Not released yet
Results date posted
| 2021 | Year | 10 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not released yet
Participant flow
Not released yet
Adverse events
Not released yet
Outcome measures
Not released yet
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2010 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 03 | Day |
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
A corrective (recall) action was issued for the Philips CPAP device, ASV device, and ventilator, and the scheduled observation end date was moved up.
Management information
Registered date
| 2017 | Year | 03 | Month | 11 | Day |
Last modified on
| 2022 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030189
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
