UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044220 |
|---|---|
| Receipt number | R000050499 |
| Scientific Title | Optimized settings for adaptive servo ventilation in patients with severe heart failure based on the echocardiogram |
| Date of disclosure of the study information | 2021/05/15 |
| Last modified on | 2021/12/22 12:01:25 |
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Basic information
Public title
Optimized settings for adaptive servo ventilation in patients with severe heart failure based on the echocardiogram
Acronym
Optimized settings for adaptive servo ventilation in patients with severe heart failure based on the echocardiogram
Scientific Title
Optimized settings for adaptive servo ventilation in patients with severe heart failure based on the echocardiogram
Scientific Title:Acronym
Optimized settings for adaptive servo ventilation in patients with severe heart failure based on the echocardiogram
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 reveal that the optimized ASV settings could be determined by evaluating outflow on the echocardiogram, thereby ensuring benefits for severe heart failure patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary study end point in the time-to-event analysis was the first event of the composite of death from any cause, or an unplanned hospitalization for worsening chronic heart failure or ventricular tachycardia.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
The patients who started ASV during hospitalization which with severe HF treated with catecholamine or who were candidates for heart transplantation.
Key exclusion criteria
The patients who had a respiratory failure, severe pulmonary disease, pure right-sided HF including pulmonary arterial hypertension, neurological or muscular disease, stenotic valvular disease, constrictive pericarditis or pericardial effusion, any intracardiac shunt, and/or intolerance of ASV.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | HARUKI |
| Middle name | |
| Last name | SEKIGUCHI |
Organization
Tokyo Women's Medical University
Division name
Division of Cardiology
Zip code
162-8666
Address
8-1 Kawadacho, Shinjyuku Ward, Tokyo
TEL
+81-33538111
sekiguchi.haruki@twmu.ac.jp
Public contact
Name of contact person
| 1st name | HARUKI |
| Middle name | |
| Last name | SEKIGUCHI |
Organization
Tokyo Women's Medical University
Division name
Division of Cardiology
Zip code
162-8666
Address
8-1 Kawadacho, Shinjyuku Ward, Tokyo
TEL
+81-33538111
Homepage URL
guccu_0418@yahoo.co.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
Tokyo Women's Medical University
Address
8-1 Kawadacho, Shinjyuku Ward, Tokyo
Tel
+81-33538111
sekiguchi.haruki@twmu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
4806
Org. issuing International ID_1
4806
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 15 | 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
160
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
Patients' characteristics, echocardiogram data, laboratory data, polysomnography data, and primary endpoint.
Management information
Registered date
| 2021 | Year | 05 | Month | 15 | Day |
Last modified on
| 2021 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050499
