UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033876
Receipt number 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 2022/09/03 00:49:37

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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 Masafumi
Middle name
Last name Kitakaze

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Clinical Medicine and Development

Zip code

564-8565

Address

6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, JAPAN

TEL

06-6170-1070

Email

kitakaze@ncvc.go.jp


Public contact

Name of contact person

1st name Miki
Middle name
Last name Imazu

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Clinical Medicine and Development

Zip code

564-8565

Address

6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, JAPAN

TEL

06-6170-1070

Homepage URL

http://ast-hf.research-assistance.net/

Email

asthf-office@ml.ncvc.go.jp


Sponsor or person

Institute

AST-HF study office

Institute

Department

Personal name



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

National Cerebral and Cardiovascular Center

Address

6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, JAPAN

Tel

06-6170-1070

Email

plandiv@ml.ncvc.go.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

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

No longer recruiting

Date of protocol fixation

2018 Year 08 Month 23 Day

Date of IRB

2017 Year 11 Month 24 Day

Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2022 Year 02 Month 15 Day

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

2022 Year 09 Month 03 Day



Link to view the page

Value
https://center6.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