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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name