Chronic heart failure with chronic renal failure
Conditions
Interventions
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.
Sponsors
AST-HF study office
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of plasma B-type natriuretic peptide concentration for 6 months from the baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMiki Imazu
National Cerebral and Cardiovascular Center Department of Clinical Medicine and Development
Outcome results
None listed