UMIN-CTR Clinical Trial

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
Last 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
1st 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