UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044220
Receipt No. 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 2021/05/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email guccu_0418@yahoo.co.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
Email 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
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 Preinitiation
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
Date trial data considered complete
Date analysis concluded

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 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050499

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.