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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033876
Receipt No. R000036696
Scientific Title The Effect of AST-120, Absorbent of Uremic Toxins on The Severity of Cardiac Failure in Patient with Chronic Heart Failure
Date of disclosure of the study information 2018/09/01
Last modified on 2019/02/26

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Basic information
Public title The Effect of AST-120, Absorbent of Uremic Toxins on The Severity of Cardiac Failure in Patient with Chronic Heart Failure
Acronym The Effect of AST-120, Absorbent of Uremic Toxins on The Severity of Cardiac Failure in Patient with Chronic Heart Failure (AST-HF study)
Scientific Title The Effect of AST-120, Absorbent of Uremic Toxins on The Severity of Cardiac Failure in Patient with Chronic Heart Failure
Scientific Title:Acronym The Effect of AST-120, Absorbent of Uremic Toxins on The Severity of Cardiac Failure in Patient with Chronic Heart Failure (AST-HF study)
Region
Japan

Condition
Condition Chronic heart failure with chronic renal failure
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether oral adsorbent (AST-120) improve heart failure in chronic heart failure patients with chronic renal failure compared with patients without AST-120-treatment in multicenter, randomized, open clinical trial.
At the same time, to investigate the optimal dose of oral adsorbent for heart failure treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Changes of plasma B-type natriuretic peptide concentration for 6 months from the baseline
Key secondary outcomes 1) Changes in the plasma B-type natriuretic peptide concentration for 6 and 12 months from the baseline
2) Change in the ratio of peak velocity of early transmitral diastolic filling by echocardiography (E) to early diastolic mitral annular velocity by tissue Doppler echocardiography (E/e') for 6 and 12 months from the baseline
3) Change in left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs) and left ventricular ejection fraction (LVEF) assessed by echocardiography for 6 and 12 months from the baseline
4) Change in the ratio of peak velocity of early transmitral diastolic filling (E) to late diastolic filling due to atrial contraction (E/A) and the deceleration time (DcT) assessed by echocardiography for 6 and 12 months from baseline
5) Changes in estimated glomerular filtration rate (eGFR) for 6 months and one year from baseline
6) Total number of hospitalization by progression of heart failure and deaths by cardiovascular events for 6 and 12 months from baseline

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 AST-120 is initiated at the dose of 3g per day for 6 months, and thereafter increased to 6g per day. If AST-120 is difficult to increase to 6g per day, AST-120 is continued at the dose of 3g per day.
Interventions/Control_2 Standard treatment of chronic kidney disease without AST-120
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) Patients with heart failure diagnosed by Framingham criteria in each participating hospital
2) Asian aged from 20 old
3) Patients with chronic renal failure in conservative therapy; in chronic kidney disease (CKD) stages 3 and 4
4) Agreement of written informed consent

CKD grade:
G1 90 ml/min/1.73m2 <= eGFR
G2 60 ml/min/1.73m2 <= eGFR <90 ml/min/1.73m2
G3 30 ml/min/1.73m2 <= eGFR <6
0 ml/min/1.73m2
G4 15 ml/min/1.73m2 <= eGFR <30 ml/min/1.73m2
G5 eGFR <= 15 ml/min/1.73m2
Key exclusion criteria 1) Patients with an allergic history of AST-120
2) Patients already treated with AST-120
3) Patients with stage 5 CKD
4) Patients suspected or diagnosed with Nephrotic syndrome
5) Patients using mechanical circulatory support devices
6) Patients waiting for heart transplant
7) Patients waiting for cardiac surgery
8) Patients with New York Heart Association (NYHA) Functional Classification, class III or IV at baseline
9) Patients with any past histories of acute coronary syndrome or coronary intervention or cardiac surgery developed within 6 months
10) Patients who start cardiac resynchronization therapy within 6 months
11) Patients who start beta blocker treatment within 6 months
12) Patients who start or change some drugs for heart failure or diabetes within 3 months
13) Patients expected to live less than 3 years
14) Patients with possible alcohol or drug abuse
15) Patients who are pregnant or possibly pregnant
16) Patients with breast feeding
17) Patients with disorder of gastrointestinal transit
18) Patients with gastrointestinal ulcer or esophageal varix
19) Patients who are prone to constipation
20) Patients who have been enrolled in other clinical studies at the same time with this study (excluding observational studies such as registry studies)
21) Patients who are judged by the investigator or subinvestigators to be not suitable for participation in the study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Kitakaze
Organization National Cerebral and Cardiovascular Center
Division name Department of Clinical Medicine and Development
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, JAPAN
TEL 06-6833-5012
Email kitakaze@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miki Imazu
Organization National Cerebral and Cardiovascular Center
Division name Department of Clinical Medicine and Development
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, JAPAN
TEL 06-6833-5012
Homepage URL http://ast-hf.research-assistance.net/
Email asthf-office@ml.ncvc.go.jp

Sponsor
Institute AST-HF study office
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
2018 Year 09 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 09 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
2018 Year 08 Month 23 Day
Last modified on
2019 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036696

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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