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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036604
Receipt No. R000041576
Scientific Title Pulmonary Hypertension affects the Prognostic Impact of Right Ventricular Function in Acute Heart Failure Patients with Left Ventricular Systolic Dysfunction
Date of disclosure of the study information 2019/04/30
Last modified on 2019/04/24

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Basic information
Public title Pulmonary Hypertension affects the Prognostic Impact of Right Ventricular Function in Acute Heart Failure Patients with Left Ventricular Systolic Dysfunction
Acronym Pulmonary Hypertension affects the Prognostic Impact of Right Ventricular Function in patients with HFrEF
Scientific Title Pulmonary Hypertension affects the Prognostic Impact of Right Ventricular Function in Acute Heart Failure Patients with Left Ventricular Systolic Dysfunction
Scientific Title:Acronym Pulmonary Hypertension affects the Prognostic Impact of Right Ventricular Function in patients with HFrEF
Region
Japan

Condition
Condition Acute heart failure with left ventricular systolic dysfunction
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the impact of right ventricular function on prognosis in acute heart failure patients with and without pulmonary hypertension
Basic objectives2 Others
Basic objectives -Others Cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The composite of cardiovascular death and rehospitalization due to heart failure
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Urgently hospitalized patients due to acutely decompensated heart failure with reduced left ventricular ejection fraction (LVEF <50%; HFrEF) in a single cardiovascular center between July 2013 and November 2017.
Key exclusion criteria 1. Patients who died in hospital.
2. Patients without full echocardiography data
Target sample size 573

Research contact person
Name of lead principal investigator
1st name Nobuhisa
Middle name
Last name Hagiwara
Organization Tokyo Women's Medical University
Division name Cardiology
Zip code 1628666
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo
TEL +81333538111
Email hagiwara.nobuhisa@twmu.ac.jp

Public contact
Name of contact person
1st name Jujo
Middle name
Last name Kentaro
Organization Tokyo Women's Medical University
Division name Cardiology
Zip code 1628666
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo
TEL +81333538111
Homepage URL
Email juken1123@mac.com

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 Ethical review board of Tokyo Women's Medical University
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo
Tel 03-3353-8111
Email krinri.bm@twmu.ac.jp

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
2019 Year 04 Month 30 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 1349
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
2015 Year 11 Month 10 Day
Date of IRB
2015 Year 12 Month 10 Day
Anticipated trial start date
2015 Year 12 Month 11 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information RV dysfunction that was estimated by a simple index RV-TDI s' may predict clinical outcomes after the discharge with pulmonary hypertension, but not in those without pulmonary hypertension.

Management information
Registered date
2019 Year 04 Month 25 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041576

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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