UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041669 |
|---|---|
| Receipt number | R000047552 |
| Scientific Title | Effectiveness and safety of morphine therapy as palliative care in advanced heart failure patients -multicenter prospective observational study- |
| Date of disclosure of the study information | 2020/09/04 |
| Last modified on | 2023/09/06 10:59:03 |
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Basic information
Public title
Effectiveness and safety of morphine therapy as palliative care in advanced heart failure patients -multicenter prospective observational study-
Acronym
Morphine-HF
Scientific Title
Effectiveness and safety of morphine therapy as palliative care in advanced heart failure patients -multicenter prospective observational study-
Scientific Title:Acronym
Morphine-HF
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effectiveness and safety of morphine therapy for dyspnea in heart failure patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in dyspnea after treatment of morphine therapy
Key secondary outcomes
Change in vital signs after treatment of morphine therapy
Adverse events after treatment of morphine therapy
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
1) Hospitalized heart failure patients diagnosed by Framingham criteria
2) Stage D heart failure patients with dyspnea (New York Heart Association functional class III or IV) despite optimal medical therapy
3) Patients who agree to participate the study with written informed consent by patients and/or their proxies
4) Patients aged 20 years-old or older at the time of obtaining informed consent
Key exclusion criteria
1) Patients with consciousness disturbance (more than or equal to Japan Coma Scale III-100)
2) Patients with ventilation
3) Patients who are judged to be inappropriate for the study by the physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Hamatani |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Cardiology
Zip code
612-8555
Address
1-1, Mukaihata-cho, fukakusa, fushimi-ku, kyoto, Japan
TEL
0756419161
y.hamatani1114@gmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Hamatani |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Cardiology
Zip code
612-8555
Address
1-1, Mukaihata-cho, fukakusa, fushimi-ku, kyoto, Japan
TEL
0756419161
Homepage URL
y.hamatani1114@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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 committee of National Hospital Organization Kyoto Medical Center
Address
1-1, Mukaihata-cho, fukakusa, fushimi-ku, kyoto, Japan
Tel
0756419161
yamaji.hirofumi.bg@mail.hosp.go.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
京都医療センター、京都大学医学部附属病院、国立循環器病研究センター、倉敷中央病院、小倉記念病院、神戸市立医療センター中央市民病院、兵庫県立尼崎総合医療センター、天理よろづ相談所病院、静岡県立総合病院、滋賀県立総合病院、三菱京都病院、大阪赤十字病院、北野病院、関西電力病院、枚方公済病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
28
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
| 2020 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the feasibility of morphine therapy for heart failure patients
Management information
Registered date
| 2020 | Year | 09 | Month | 03 | Day |
Last modified on
| 2023 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047552
