UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009687 |
|---|---|
| Receipt number | 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 13:17:36 |
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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
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
Sponsor or person
Institute
Department of Cardiology, Tokushima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011360
