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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043293
Receipt No. R000049430
Scientific Title Effect of PHARMacological treatment in hospitalized patients with Heart Failure
Date of disclosure of the study information 2021/02/12
Last modified on 2021/02/10

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Basic information
Public title Effect of PHARMacological treatment in hospitalized patients with Heart Failure
Acronym PHARM-HF
Scientific Title Effect of PHARMacological treatment in hospitalized patients with Heart Failure
Scientific Title:Acronym PHARM-HF
Region
Japan

Condition
Condition Heart failure
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To ascertain the cardiovascular agonists used, blood pressure, and renal function of patients admitted for exacerbation of heart failure during the first 10 days of hospitalization (consecutive days), at discharge, and at the first outpatient visit. In addition, changes in blood pressure and renal function and subjective symptoms, cardiac function, biomarkers, and activity level will be ascertained.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Systolic and diastolic blood pressure during hospitalization
Key secondary outcomes Clinical outcome (death and rehospitalization due to heart failure) on 1 and 2 years after discharge

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 Hospitalized patients with a diagnosis of worsening heart failure defined by the Framingham criteria.
Key exclusion criteria Use of mechanical circulatory support, mechanical ventilation, hemodialysis, and inotropes(dobutamine, noradrenaline, dopamine, epinephrine).
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Masaaki
Middle name
Last name Konishi
Organization Yokohama City University Hospital
Division name Department of Medical Science and Cardiorenal Medicine
Zip code 2360004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 0457872800
Email m_koni@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Masaaki
Middle name
Last name Konishi
Organization Yokohama City University
Division name Department of Medical Science and Cardiorenal Medicine
Zip code 2360004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 0457872800
Homepage URL
Email m_koni@yokohama-cu.ac.jp

Sponsor
Institute Department of Medical Science and Cardiorenal Medicine, Yokohama City University
Institute
Department

Funding Source
Organization Yokohama City 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 Yokohama City University Certified Institutional Review Board
Address 3-9 Fukuura, Kanazawa-ku
Tel 0457872800
Email ycu_crb@yokohama-cu.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

Other administrative information
Date of disclosure of the study information
2021 Year 02 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 12 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Preinitiation

Management information
Registered date
2021 Year 02 Month 10 Day
Last modified on
2021 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049430

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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