UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011456 |
|---|---|
| Receipt number | R000013412 |
| Scientific Title | Acute Effect of Adaptive Servo Ventilation for Cardiac Rehabilitation |
| Date of disclosure of the study information | 2013/08/12 |
| Last modified on | 2018/02/20 16:32:22 |
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Basic information
Public title
Acute Effect of Adaptive Servo Ventilation for Cardiac Rehabilitation
Acronym
ASV with Cardiac Rehabilitation
Scientific Title
Acute Effect of Adaptive Servo Ventilation for Cardiac Rehabilitation
Scientific Title:Acronym
ASV with Cardiac Rehabilitation
Region
| Japan |
Condition
Condition
heart failure with reduced ejection fraction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of adaptive servo-ventilation therapy for cardiac function in heart failure with reduced ejection fraction who enforces cardiac rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Left ventricular ejection fraction, peak oxygen uptake
Key secondary outcomes
NYHA class, Change in plasma BNP level, Cardiac death, Cardiovascular event, Admission due to heart failure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
application of adaptive servo-ventilation
Interventions/Control_2
non-application of adaptive servo-ventilation
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with cardiac rehabilitation during hospitalization for heart failure
2)EF < 40%
3)NYHA class >= 2
4)written consent
Key exclusion criteria
1)Patients who are hospitalized for ACS within 14 days of onset
2)Patients with CABG operation within 3 months
3)scheduled invasive procedure
4)ASV using difficulty by a physical factor
5)using home respiratory device already
6)Patients considered not eligible for the study by the attending doctor due to other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Yoshiyama |
Organization
Osaka city university graduate school of medicine
Division name
Department of cardiovascular medicine
Zip code
Address
1-4-3, Asahimachi Abeno-ku, Osaka
TEL
06-6645-3801
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Shibata |
Organization
Osaka city university graduate school of medicine
Division name
Department of cardiovascular medicine
Zip code
Address
TEL
06-6645-3801
Homepage URL
Sponsor or person
Institute
Department of cardiovascular medicine
Osaka city university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of cardiovascular medicine
Osaka city university graduate school of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 11 | Day |
Last modified on
| 2018 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013412
