UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011769 |
|---|---|
| Receipt number | R000013758 |
| Scientific Title | Effects of daytime ASV therapy on heart failure |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2013/09/14 16:30:43 |
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Basic information
Public title
Effects of daytime ASV therapy on heart failure
Acronym
Daytime ASV therapy in patients with heart failure
Scientific Title
Effects of daytime ASV therapy on heart failure
Scientific Title:Acronym
Daytime ASV therapy in patients with heart failure
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of daytime ASV therapy on heart failure patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiovascular events
Key secondary outcomes
Plasma norepinephrine, serum creatinine, microalbuminurea, eGFR, hs-CRP, Hb, BGA, LVEF, Dd, Ds, LVEDV, LVESV, E/A, E/e', LA volume, BNP, administration changes due to HF worsening, polysomnography, respiratory function data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Adaptive servo-ventilation
Interventions/Control_2
without 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic heart failure
1) NYHA II or III
2) LVEF<45%
3) stable HF patients whose prescriptions are not changed more than 1 month
4) conventional medical therapy is performed
Key exclusion criteria
1) patients undergoing positive airway pressure
2) patients undergoing hemodialysis
3) chronic and acute inflammation disease or malignant disease
4) phyaryngial disease
5) patients who could not have conventional medical therapy
6) uncontrolled diabetes and hypertension
7) hepatitis, liver cirrhosis, liver cancer, joundice
8) acute coronary syndrome
9) patients who will have heart surgery
10) pregnant
11) patients who will have pacing therapy
12) patients who have serious cerebrovascular disease
13) patients who have intravenous administration for heart failure
14) chronic renal failure (Cre>=3.0)
15) serious respiratory disease
16) subjects whose doctor in charge do not
agree to join the trial
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ito |
Organization
Akita University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Hondoh 1-1-1, Akita
TEL
018-884-6110
tkoyama-tym@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Koyama |
Organization
Akita University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Hondoh 1-1-1, Akita
TEL
018-884-6110
Homepage URL
takashixkoyama@gmail.com
Sponsor or person
Institute
Department of Cardiovascular and Medicine, Akita University Graduate School of Medicine,
Institute
Department
Personal name
Funding Source
Organization
none
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 | 10 | 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
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | 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 | 09 | Month | 14 | Day |
Last modified on
| 2013 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013758
