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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010762
Receipt No. R000012554
Scientific Title Effects of erythropoiesis stimulating agentin on heart failure patients with reduced left ventricular function and the cardiorenal anemia syndrome
Date of disclosure of the study information 2013/05/20
Last modified on 2016/02/10

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Basic information
Public title Effects of erythropoiesis stimulating agentin on heart failure patients with reduced left ventricular function and the cardiorenal anemia syndrome
Acronym Effects of erythropoiesis stimulating agent on heart failure patients
Scientific Title Effects of erythropoiesis stimulating agentin on heart failure patients with reduced left ventricular function and the cardiorenal anemia syndrome
Scientific Title:Acronym Effects of erythropoiesis stimulating agent on heart failure patients
Region
Japan

Condition
Condition Chronic heart failure patients with reduced left ventricular function
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate the effect of erythropoiesis stimulating agent on chronic heart failure patients with the cardiorenal anemia syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sudden cardiac death, death and hospitalization due to worsening heart failure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 with anemia
Interventions/Control_2 without anemia
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Hb<12g/dl and eGFR<60ml/min/1.73m2 for atleast 3 months
2. Optimal pharmacologic therapy including ACEI, ARB and beta-blockers
3. TSAT>15.0%, Vit B12, folate concentration in the normal range
Key exclusion criteria 1. uncontrolled hypertension (>160/100 mmHg)
2. previous history of cardiovascular disease within 3 months
3. new-onset of atrial fibrillation and atrial flutter within one month
4. Cr>3mg/dl
5. renal transplantation within 6 months, or chemo and radiation therapy within 12 months. Previous history of malignant disease, hematological disorder.
6. allergy of ESA
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidekazu Tanaka
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kobe University Graduate School of Medicine
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address
TEL
Homepage URL
Email tanakah@med.kobe-u.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 20 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 Terminated
Date of protocol fixation
2013 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 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 05 Month 20 Day
Last modified on
2016 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=R000012554

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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