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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009687
Receipt No. R000011360
Scientific Title Usefulness of Low-dose Pimobendan for Patients with Chronic Heart Failure
Date of disclosure of the study information 2013/01/04
Last modified on 2013/01/04

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Basic information
Public title Usefulness of Low-dose Pimobendan for Patients with Chronic Heart Failure
Acronym LDP-CHF study
Scientific Title Usefulness of Low-dose Pimobendan for Patients with Chronic Heart Failure
Scientific Title:Acronym LDP-CHF study
Region
Japan

Condition
Condition Chronic heart failure patients receiving treatment in the hospital for heart failure hospitalization, transition to outpatient therapy
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine the effect of low dose pimobendan to the improvement of cardiac function and symptoms in patients with chronic heart failure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Symptoms due to chronic heart failure, exercise capacity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of low-dose Pimobendan (1.25 mg/day ~2.5mg/day)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with non-ischemic heart disease
2. Serum Creatinine less than 2.5 mg/dl
3. Patients or legal representatives who agree with the study and sign agreement in writing
Key exclusion criteria 1. Patients with hypertrophic obstructive cardiomyopathy and/or obstructive heart valve disease
2. Patients with acute myocardial infarction.
3. Patients with advanced atrioventricular block and/or and lethal arrhythmia.
4. Patients with severe cerebrovascular disease
5. Patients with severe hepatic and renal failure
6. Patients with a possibility of pregnancy, pregnant or lactating
7. Patients who are judeged not to eligible for partitipation to this study by attending physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masataka Sata
Organization Tokushima University Hospital
Division name Department of Cardiology
Zip code
Address Kuramoto-cho 2-50-1, Tokushima, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Iwase
Organization Tokushima University Hospital
Division name Department of Cardiology
Zip code
Address Kuramoto-cho 2-50-1, Tokushima, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Cardiology, Tokushima University Hospital
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine, Institute of Health Biosciences, The University of Tokushima Graduate School, Tokushima
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 徳島大学病院(徳島県)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 04 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 Enrolling by invitation
Date of protocol fixation
2013 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 04 Day
Last modified on
2013 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011360

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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