UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027534 |
|---|---|
| Receipt number | R000031561 |
| Scientific Title | Characterization of monitoring factors indicating acute worsening of chronic heart failure |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/08/24 12:18:42 |
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Basic information
Public title
Characterization of monitoring factors indicating acute worsening of chronic heart failure
Acronym
Monitoring factors for acute worsening of chronic heart failure
Scientific Title
Characterization of monitoring factors indicating acute worsening of chronic heart failure
Scientific Title:Acronym
Monitoring factors for acute worsening of chronic heart failure
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to explore physical- and biochemical factors that indicate acute worsening of chronic heart failure.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, blood pressure, SpO2, biochemical data, echocardiograhical data at the onset and improved phase of acute worsening of chronic 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic heart failure who were administered in Hyogo Pref. Kaibara Hospital, Tanba City, Hyogo, Japan.
Key exclusion criteria
Patients with data missing. Patients who did not agree to participate in the study.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Tatsuro |
| Middle name | |
| Last name | Ishida |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Community Medicine and Medical Network
Zip code
6500017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5846
ishida@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Ishida |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Community Medicine and Medical Network
Zip code
6500017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5846
Homepage URL
ishida@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine
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
Kaibara Hospital
Address
5208-1 Kaibara, Hyogo, Japan
Tel
0795-72-0524
ahozu@hp.pref.hyogo.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
兵庫県立柏原病院（兵庫）、神戸大学大学院医学研究科（兵庫）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
in press
Publication of results
Published
Result
URL related to results and publications
in press
Number of participants that the trial has enrolled
207
Results
Body weight, blood pressure, pulse rate, and serum BNP level were higher at the onset of uncompensated heart failure and improved by medical treatment at the recovered status. The body weight was significantly associated with serum BNP level as well as echocardiographic indices such as %FS, IVS dimension, and TR-pressure gradient. There, daily monitoring of body weight was useful for the patients with heart failure to recognize the worsening of heart failure.
Results date posted
| 2020 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The early notice of worsening of chronic heart failure is very important for improving the prognosis. this study aimed to identify the marker or factor which can indicate the worsening of chronic heart failure in old outpatients in the local community.
Participant flow
Clinical markers or indicators for heart failure were retrospectively compared between the onset and recovered status of uncompensated heart failure.
Adverse events
None
Outcome measures
Body weight, blood pressure, SpO2, biochemical data,
echocardiographicl data at the onset and recovered status of uncompensated heart failure.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | 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
Observational study based on medical records.
Management information
Registered date
| 2017 | Year | 05 | Month | 29 | Day |
Last modified on
| 2020 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031561
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