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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011769
Receipt No. 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

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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
Email 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
Email takashixkoyama@gmail.com

Sponsor
Institute Department of Cardiovascular and Medicine, Akita University Graduate School of Medicine,
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013758

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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