UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021859 |
|---|---|
| Receipt number | R000025204 |
| Scientific Title | analysis of biomarkers in patients with acute heart failure |
| Date of disclosure of the study information | 2016/04/11 |
| Last modified on | 2021/11/15 13:58:37 |
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Basic information
Public title
analysis of biomarkers in patients with acute heart failure
Acronym
analysis of biomarkers in patients with acute heart failure
Scientific Title
analysis of biomarkers in patients with acute heart failure
Scientific Title:Acronym
analysis of biomarkers in patients with acute heart failure
Region
| Japan |
Condition
Condition
patients with acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
analyzing the change and utility of biomarkers in acute heart failure
Basic objectives2
Others
Basic objectives -Others
analyzing the relationships between biomarkers and other clinical parameters in acute heart failure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiac death, admission for heart failure
(90 days, 180days, 1year)
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 admitted for acute heart failure
Key exclusion criteria
acute coronary syndrome
infection
require left ventricular assist device
severe comorbidities (end-stage malignancy, liver cirrhosis, severe lung disease, severe collagen and autoimmune disease)
patients who are perceived to be difficult for follow-up
*patients with renal dysfunction will be analyzed separately
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka red cross hospital
Division name
cardiovascular center
Zip code
543-8555
Address
5-30 Fudegasaki, Tennouji-ku, Osaka
TEL
06-6774-5111
nagao@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Nagao |
Organization
Osaka red cross hospital
Division name
cardiovascular center
Zip code
543-8555
Address
5-30 Fudegasaki, Tennouji-ku, Osaka
TEL
06-6774-5111
Homepage URL
nagao@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Osaka red cross hospital
cardiovascular center
Institute
Department
Personal name
Funding Source
Organization
Osaka red cross hospital
cardiovascular center
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
Osaka Red Cross Hospital
Address
5-30 Fudegasaki, Tennouji-ku, Osaka, Japan
Tel
06-6774-5111
soumudaiichi@osaka-med.jrc.or.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
| 2016 | Year | 04 | Month | 11 | Day |
Related information
URL releasing protocol
Open Heart . 2020 Apr 5;7(1):e001041. doi: 10.1136/openhrt-2019-001041. eCollection 2020
Publication of results
Published
Result
URL related to results and publications
Open Heart . 2020 Apr 5;7(1):e001041. doi: 10.1136/openhrt-2019-001041. eCollection 2020
Number of participants that the trial has enrolled
390
Results
The cumulative 90-day and 365-day incidence of the primary outcome measure was 19.9% vs 13.0% (p=0.04) and 32.3% vs 29.0% (p=0.34) in the patients with high and low P4NP 7S, respectively. High P4NP 7S correlated with significant excess risk relative to low P4NP 7S for both 90-day and 365-day primary outcome measure (adjusted HR, 1.50; 95% CI, 1.02 to 2.21; p=0.04 and adjusted HR, 1.89; 95% CI, 1.11 to 3.26; p=0.02, respectively).
Results date posted
| 2021 | Year | 11 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age (years) 76.2
Male 207 (53)
Hypertension 301 (77)
Diabetes mellitus 138 (35)
Ischaemic heart disease 112 (29)
EF<40% 154 (39)
BNP (pg/mL) 266 (121-480)
Participant flow
eligible patients=403
death during hospitalization n=13
study patients=390
Adverse events
none
Outcome measures
The prespecified primary outcome measure in this study was a composite of 365-day cardiac death and HF hospitalisation. The secondary outcome measures were individual components of the primary outcome measure and all-cause death. In addition, our prior exploratory analysis and the previous study by others suggested that the prognostic effect of LFTs and collagen markers might be time-dependent and that the impact of these markers on short-term and long-term outcomes might be different.7 8 Hence, as prespecified analyses, we also investigated the time-dependent prognostic utility of each collagen marker separately within and beyond 90 days.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 02 | Month | 15 | Day |
Other
Other related information
objective
relationships between the biomarker and cardiac death, heart failure hospitalization
relationships between change of the biomarker and prognosis
relationships between the biomarker and other signs and parameters
Management information
Registered date
| 2016 | Year | 04 | Month | 10 | Day |
Last modified on
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025204
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