UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036604 |
|---|---|
| Receipt number | 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 00:15:29 |
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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
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
juken1123@mac.com
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
Ethical review board of Tokyo Women's Medical University
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo
Tel
03-3353-8111
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041576
