Subjects hospitalized with worsening congestive heart failure (CHF).
Conditions
Interventions
Product Name: Tolvaptan
Product Code: OPC-41061
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharm
Sponsors
Otsuka Maryland Research Institute, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 years. 2. Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to randomization. Chronic heart failure is defined as requiring treatment for a minimum of 30 days prior to hospitalization. 3. The subject must have signs of extracellular volume expansion, defined as two or more of the following: a) jugular venous distention; b) pitting edema (>1+); or c) dyspnea at the time of randomization. 4. NYHA Class III or IV at the time of hospitalization. 5. Most recent LVEF =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women who will not adhere to the reproductive precautions as outlined in the Informed Consent form. 2. Positive urine pregnancy test. 3. Inability to provide written informed consent. 4. Cardiac surgery within 60 days of potential study enrollment, excluding percutaneous coronary interventions. 5. Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study enrollment. 6. Subjects who are on cardiac mechanical support. 7. History of bi-ventricular pacer placement within the last 60 days. 8. Co-morbid condition with an expected survival less than six months. 9. Subjects with acute ST segment elevation myocardial infarction at the time of hospitalization. 10. History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator. 11. History of a cerebrovascular accident within the last 30 days. 12. Hemodynamically significant uncorrected primary cardiac valvular disease. 13. Hypertrophic cardiomyopathy (obstructive or non-obstructive). 14. CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy. 16. History of primary significant liver disease or acute hepatic failure, as defined by the investigator. 17. Chronic uncontrolled diabetes mellitus as determined by the investigator. 18. Morbid obesity, defined as > 159 kg (or 350 lbs) or BMI > 42. 19. Supine systolic arterial blood pressure 3.5 mg/dL or > 309.4 µmol/L. 21. Serum potassium > 5.5 mEq/L or > 5.5 mmol/L. 22. Hemoglobin < 9 g/dL or < 90 g/L or 5.586 mmol/L. 23. History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazapril). 24. History of drug or medication abuse within the past year, or current alcohol abuse. 25. Inability to take oral medications. 26. Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted. 27. Previous participation in this or any other tolvaptan clinical trial. 28. Subjects with refractory, end-stage, heart failure defined as subjects who are appropriate candidates for specialized treatment strategies, such as ventricular assist devices, continuous positive IV inotropic therapy, or hospice care. 29. Subjects currently treated with hemofiltration or dialysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of tolvaptan or placebo in conjunction with optimal (as determined by the investigator) current therapy on the time to all-cause mortality in subjects hospitalized with worsening CHF. To compare the efficacy of tolvaptan or placebo in conjunction with optimal (as determined by the investigator) current therapy on the time to first occurrence of CV mortality or hospitalization for heart failure. Embedded Trials (Trial A and Trial B): To compare the efficacy of tolvaptan or placebo in conjunction with optimal (as determined by the investigator) current therapy on the change from baseline in patient-assessed global clinical status at Inpatient Day 7 or discharge, if earlier.;Secondary Objective: To compare the efficacy of tolvaptan or placebo in conjunction with optimal (as determined by the investigator) current therapy. To assess the safety of tolvaptan or placebo in conjunction with optimal (as determined by the investigator) current therapy by comparing: Embedded Trials (Trial A and Trial B): To compare the efficacy of tolvaptan or placebo in conjunction with optimal current therapy;Primary end point(s): The primary efficacy endpoint in the primary outcome study is the time to all-cause mortality or the time to first occurrence of CV mortality or heart failure hospitalization. The primary efficacy endpoint in the embedded trials is the change from baseline in patient-assessed global clinical status at Inpatient Day 7 or discharge, if earlier. | — |
Countries
Lithuania
Outcome results
None listed