congestive heart failure and chronic kidney disease
Conditions
Interventions
1. acute-phase trial Start treatment with 15 mg tolvaptan with concomitant use of diuretics prescribed for the initial assessment period of 15 days. 2. long-term follow-up study Patients who tole
Sponsors
Fujita Health University School of Medicine
Chita City Hospital, Okazaki City Hospital, TOYOTA Memorial Hospital, Tono Kosei Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Irrespective of the route of administration, the patients are prescribed diuretics equivalent to a dose of furosemide between 20-240 mg/day, and the diuretic dose was not changed between day 1 and day 2 2. Patients satisfying the criteria of GFR <60 ml/min/1.73m2 or urine protein of >=0.50 g/gCr (g/day) or urine protein >=2+ assessed by using test tape 3. Patients satisfying the Framingham criteria for CHF
Exclusion criteria
Exclusion criteria: 1. Patients who recently started undergoing hemodialysis 2. Patients treated with the following drugs during the initial eligibility assessment period (a) Phosphodiesterase III inhibitors (amrinone, milinone, or loprinone) (b) Catecholamines (c) Colforsins 3. Acute renal failure 4. Hypernatremia, Na levels &#8805;147 mEq/dL 5. Patients unable to sense thirst or those with difficulty drinking water 6. Anuria 7. Patients with malignancy, including multiple myeloma or primary amyloidosis 8. Patients suspected of having loss of circulating plasma volume or patients with hypotension 9. Severe aortic stenosis or severe dilated cardiomyopathy 10. Acute coronary syndrome 11. Recent myocardial infarction, percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) within the past 3 months 12. Patients scheduled for PCI or CABG 13. Stroke within the past 3 months 14. Severe neuropsychological deficit 15. Severe liver damage or hepatic coma 16. Severe obstructive and/or restrictive lung disease 17. Severe pulmonary hypertension 18. Patients with other life-threatening illnesses 19. Pregnant women 20. Allergy to tolvaptan 21. Others deemed ineligible for this trial by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.acute-phase trial Absolute change of body weight, rate of increase/decrease of body weight. Development of acute kidney injury on CKD Bioelectrical impedance analysis: Extracellular water, intracellular water, and total body water 2.long term follow up study Delta estimated glomerular filtration rate (eGFR), 50% decrease in eGFR Composite outcome: 50% decrease in eGFR+induction of renal replacement therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.acute-phase trial Renal function tests:serum creatinine, eGFR, urine osmolality, and urine 24-hour Na excretion Neurohumoral factors:plasma renin activity, serum aldosterone, and plasma catecholamine fraction, plasma midkine level, urine angiotensinogen level, urine midkine level, N-terminal prohormone of brain natriuretic peptide, arginine vasopressin, and urine aquaporin-2 Dose of diuretics converted for furosemide Other concomitant drugs for treating CHF: atrial natriuretic peptides, phosphodiesterase III inhibitors, catecholamines, and colforsins Health related QOL indicators (SF-36) Induction of renal replacement therapy Length of initial hospitalization 2.long-term follow-up study Absolute change in body weight and rate of change Health-related QOL indicator measured by using the SF-36 Cardiac echocardiography imaging Re-hospitalization for CHF Direct cost of medical expenditure from claim data Cardiovascular events Total mortality | — |
Countries
Japan
Contacts
Public ContactHiroki Hayashi
Fujita Health University School of Medicine Department of Nephrology
Outcome results
None listed