UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034669 |
|---|---|
| Receipt number | R000039524 |
| Scientific Title | The Adequacy of New Definition of Pulmonary Hypertension in Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction |
| Date of disclosure of the study information | 2018/11/02 |
| Last modified on | 2020/04/28 14:59:49 |
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Basic information
Public title
The Adequacy of New Definition of Pulmonary Hypertension in Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction
Acronym
Pulmonary Hypertension in HFpEF
Scientific Title
The Adequacy of New Definition of Pulmonary Hypertension in Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction
Scientific Title:Acronym
Pulmonary Hypertension in HFpEF
Region
| Japan |
Condition
Condition
Heart failure with preserved ejection fraction (HFpEF)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the relationship between pulmonary arterial pressure (PAP) levels and other biomarker of HF in patient with HFpEF and to investigate the prognostic involvement of PAP levels in the future cardiovascular events in patients with HFpEF.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite endopoint of cardiovascular death, non-fatal myocardial infarction, unstable anginapectoris, non-fatal stroke, or re-hospitalization for 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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with HF who were hospitalized in Kumamoto University Hospital
Key exclusion criteria
Do not meet diagnostic criteria for HFpEF
Severe valvular disease
Systemic inflammatory disease
End stage of chronic kidney disease
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tsujita |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
TEL
81-96-373-5175
cvmhisho@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Nishihara |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
TEL
81-96-373-5175
Homepage URL
t-nishi@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto 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
Graduate School of Medical Sciences, Kumamoto University
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
Tel
81-96-373-5657
ski-shien@jimu.kumamoto-u.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
熊本大学病院(熊本県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.atsjournals.org/doi/10.1164/rccm.201901-0148LE
Number of participants that the trial has enrolled
183
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
Main results already published
Date of protocol fixation
| 2007 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2007 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients were followed at the outpatient clinic until December 2016 or until an endpoint occured.
Management information
Registered date
| 2018 | Year | 10 | Month | 27 | Day |
Last modified on
| 2020 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039524
