Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management
Brief Summary: The purpose of this study is to evaluate the short term efficacy and safety of tolvaptan in subjects hospitalized for worsening heart failure who have volume overload and one of the following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy. The primary variable for assessing efficacy will be self-assessed 7-point dyspnea score at 8 and 16 hours.


Options:
A: Inclusion Criteria:

1. Informed consent.
2. Age:18～75 (when informed consent is obtained)，male or female.
3. Non-hypovolemic and non acute hyponatremia with a Serum sodium \< 135mEq/L before randomization. (main underlying diseases include CHF, hepatic cirrhosis with edema, SIADH and others)
4. In-patient subjects.
B: Inclusion Criteria:

1. Subjects hospitalized for worsening heart failure and randomized within 36 hours of initial presentation.
2. Males and females 18 years of age or older.
3. NYHA Class III or IV on admission to the hospital.
4. Able to understand content of and willing to provide written informed consent
5. Dyspnea, measured by the 5-point current dyspnea scale (moderately short of breath or worse), within 2 hours of randomization and dosing.

   The following must be met within 12 hours of randomization.
6. The subject must have signs of extracellular volume expansion, defined as two or more of the following five: Signs of RHF ( jugular venous distention, pitting edema (≥1+), ascites) and/or Signs of LHF (pulmonary congestion on chest x-ray, pulmonary rales)
7. Have at least one of the following:

   * eGFR \< 60ml/min/1.73m2, OR
   * serum sodium ≤ 134 mEq/L, OR
   * urine output ≤ 125 ml/hr over anytime frame of at least 2 hours, following administration of IV furosemide of at least 40mg. See table below.

Time Period (hr) Cumulative UO (mL) 2 \<250 3 \<375 4 \<500 5 \<625 6 \<750 7 \<875 8 \<1000

Exclusion Criteria:

1. Positive urine pregnancy test for women of child bearing potential.
2. Inability to provide written informed consent.
3. Cardiac surgery within 60 days prior to study randomization.
4. Acute Coronary Syndrome (ACS) or percutaneous coronary intervention within 30 days prior to study randomization.
5. Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization.
6. Planned electrophysiologic (EP) device implantation within 7 days following study randomization.
7. Subjects who are on cardiac mechanical support.
8. Co-morbid condition with an expected survival less than six months.
9. History of a cerebrovascular accident within the last 30 days.
10. Hemodynamically significant uncorrected primary cardiac valvular disease.
11. Hypertrophic cardiomyopathy (obstructive or non-obstructive).
12. Uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy.
13. History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
14. Chronic uncontrolled diabetes mellitus as determined by the investigator.
15. Supine systolic arterial blood pressure \< 90 mmHg.
16. Serum creatinine \> 3.5 mg/dL or undergoing dialysis.
17. Hemoglobin \< 9 g/dL
18. History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazepril).
19. Inability to take oral medications.
20. 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.
21. Previous exposure to tolvaptan within 7 days prior to randomization.
22. 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.
23. Ultrafiltration within 7 days prior to randomization or planned.
24. Active gout
25. Serum sodium \>144 mEq/L
C: Inclusion Criteria

* Hyponatremia in euvolemic or hypervolemic states, defined as serum sodium \<135 mEq/L prior to randomization.
* Able to give Informed Consent

Exclusion Criteria

* Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
* Hyponatremia in hypovolemic states.
* Acute and transient hyponatremia associated with head trauma or post-operative state.
* Hyponatremia due to uncontrolled hypothyroidism or uncontrolled adrenal insufficiency.
* Cardiac surgery within 30 days of potential study enrollment, excluding percutaneous coronary interventions.
* History of a myocardial infarction within 30 days of potential study enrollment.
* History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator.
* Severe angina including angina at rest or at slight exertion and/or unstable angina.
* History of a cerebrovascular accident within the last 30 days. 10) Subjects with psychogenic polydipsia may not be included, however subjects with other psychiatric illness may be included.
* Systolic arterial blood pressure \<90 mmHg.
* History of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril).
* History of drug or medication abuse within the past year,or current alcohol abuse.
* Uncontrolled diabetes mellitus defined as fasting glucose \>300mg/dL.
* Urinary tract obstruction except BPH if non-obstructive.
* Previous participation in another clinical drug trial within the past 30 days.
* Previous participation in this or any other tolvaptan clinical trial.
* Terminally ill or moribund condition with little chance of short term survival.
* Serum creatinine \>3.5 mg/dL.
* Serum sodium \<120 mEq/L with associated neurologic impairment, i.e. symptoms such as apathy, confusion, seizures.
* Patients with progressive or episodic neurologic disease such as multiple sclerosis or history of multiple strokes.
* Child-Pugh score greater than 10 (unless approved)
* Patients receiving intravenous fluids at a rate greater than KVO (Keep Vein Open).
* Hyponatremia due to lab artifacts
* Patients receiving AVP or its analogs for treatment of any condition.
* Patients receiving within 7 days of randomization, other medications for treatment of hyponatremia specifically: demeclocycline, lithium carbonate or urea
* Patients likely requiring IV saline for correction of symptomatic or asymptomatic severe hyponatremia during the course of the study.
* Severe pulmonary artery hypertension
* Hyponatremia should not be the result of any medication that can safely be withdrawn
D: Inclusion Criteria:

* Cirrhosis of the liver confirmed by ultrasound, endoscopic examination, or biochemical evidence
* Moderate or tense ascites
* Patients with hyponatremia, defined as a serum sodium concentration of ≤130 mmol/L

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Answer: B