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 |
The Effect of AST-120, Absorbent of Uremic Toxins on The Severity of Cardiac Failure in Patient with Chronic Heart Failure
The Effect of AST-120, Absorbent of Uremic Toxins on The Severity of Cardiac Failure in Patient with Chronic Heart Failure (AST-HF study)
The Effect of AST-120, Absorbent of Uremic Toxins on The Severity of Cardiac Failure in Patient with Chronic Heart Failure
The Effect of AST-120, Absorbent of Uremic Toxins on The Severity of Cardiac Failure in Patient with Chronic Heart Failure (AST-HF study)
Japan |
Chronic heart failure with chronic renal failure
Cardiology | Nephrology |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Changes of plasma B-type natriuretic peptide concentration for 6 months from the baseline
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
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.
Standard treatment of chronic kidney disease without AST-120
20 | years-old | <= |
Not applicable |
Male and Female
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
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
50
1st name | Masafumi |
Middle name | |
Last name | Kitakaze |
National Cerebral and Cardiovascular Center
Department of Clinical Medicine and Development
564-8565
6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, JAPAN
06-6170-1070
kitakaze@ncvc.go.jp
1st name | Miki |
Middle name | |
Last name | Imazu |
National Cerebral and Cardiovascular Center
Department of Clinical Medicine and Development
564-8565
6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, JAPAN
06-6170-1070
http://ast-hf.research-assistance.net/
asthf-office@ml.ncvc.go.jp
AST-HF study office
Japan Agency for Medical Research and Development
Japanese Governmental office
Japan
National Cerebral and Cardiovascular Center
6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, JAPAN
06-6170-1070
plandiv@ml.ncvc.go.jp
NO
2018 | Year | 09 | Month | 01 | Day |
Unpublished
No longer recruiting
2018 | Year | 08 | Month | 23 | Day |
2017 | Year | 11 | Month | 24 | Day |
2018 | Year | 09 | Month | 01 | Day |
2022 | Year | 02 | Month | 15 | Day |
2018 | Year | 08 | Month | 23 | Day |
2022 | Year | 09 | Month | 03 | Day |
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 |