Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Efficacy and Safety Study to Evaluate the Effects of Oral Administration of Lixivaptan in Patients With Congestive Heart Failure
Brief Summary: The purpose of this study is to evaluate the effects of oral lixivaptan capsules in patients with congestive heart failure.


Options:
A: Inclusion Criteria:

* Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
* Patients having undergone therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of ≥4 L of fluid
* Patients having undergone at least 1 other therapeutic paracentesis in the previous 3 months

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

* Ability to understand the purpose and risks of the study and to provide signed and dated informed consent.
* Men and women aged 18 years or older.
* History of chronic CHF defined as requiring standard HF treatment (including diuretics) for a minimum of 30 days.
* Documented LVEF by any method within 12 months prior to screening.
* The patient has clinical evidence of volume overload at the time of inclusion with at least one of the following:

  * Dyspnea
  * Pulmonary congestion (rales)
  * Peripheral edema
  * Increased jugular venous pressure and/or hepatic congestion with ascites
  * Chest x-ray consistent with CHF
  * Plasma brain natriuretic peptide (BNP) ≥150 pg/mL or N-terminal prohormone brain natriuretic peptide (NT pro-BNP) ≥450 pg/mL

Exclusion Criteria:

* Women who are pregnant (positive pregnancy test), breastfeeding, or who will not adhere to the reproductive precautions as outlined in this protocol and in the informed consent form (ICF).
* Sustained (three blood pressure measurements over 1 hour) systolic blood pressure \<90 mmHg at Screening or Day 0.
* ST segment elevation myocardial infarction or stroke within 30 days prior to Screening.
* Hemodynamically destabilizing cardiac arrhythmia within 30 days prior to Day 0.
* Clinically significant valvular disease.
* Known clinically significant obstructive, restrictive, or hypertrophic cardiomyopathy.
* Cardiac surgery or percutaneous coronary intervention within 30 days prior to Day 0.
* Major surgical procedure within 7 days prior to Day 0.
* Likely to undergo cardiac transplantation, left ventricular assist device (LVAD) or other device implantation, or other cardiac surgery within 3 months after Screening.
* Placement of implantable cardioverter defibrillator or cardiac resynchronization therapy device within 60 days prior to Day 0.
* CHF due to uncorrected thyroid disease, active myocarditis, or known amyloid cardiomyopathy.
* Presence of any clinically significant (as determined by the Investigator) endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, oncologic, and/or other major disease that might interfere with safe and compliant participation in this study.
* Screening laboratory findings as follows:

  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the upper limit of normal
  * Total bilirubin \>2.0 mg/dL
  * Serum creatinine \>3.0 mg/dL
  * Hemoglobin \<9.0 g/dL
* Uncontrolled diabetes mellitus as defined by the Investigator (e.g., glycosylated hemoglobin \[HbA1c\] \>9%).
* History of chronic drug/medication abuse within the past 6 months; or current alcohol abuse.
* Co-morbid condition with an expected survival of less than 3 months.
* Known allergy to any vasopressin antagonist or any condition for which treatment with a vasopressin antagonist may present undue risk to the patient.
* Current or recent administration (within 7 days of Day 0) of prohibited medications as listed in Section 8.6.4 .
* Participation in any other investigational study of drugs or devices within 30 days prior to Screening.
C: Inclusion Criteria:

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

Exclusion Criteria:

1. Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
2. Hyponatremia in hypovolemic states.
3. Acute and transient hyponatremia associated with head trauma or post-operative state.
4. Hyponatremia due to uncontrolled hypothyroidism or uncontrolled adrenal insufficiency.
5. Cardiac surgery within 30 days of potential study enrollment, excluding percutaneous coronary interventions.
6. History of a myocardial infarction within 30 days of potential study enrollment.
7. History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator.
8. Severe angina including angina at rest or at slight exertion and/or unstable angina.
9. 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.
11. Systolic arterial blood pressure \<90 mmHg.
12. History of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril.).
13. History of drug or medication abuse within the past year,or current alcohol abuse.
14. Uncontrolled diabetes mellitus defined as fasting glucose \>300mg/dL.
15. Urinary tract obstruction except BPH if non-obstructive.
16. Previous participation in another clinical drug trial within the past 30 days.
17. Previous participation in this or any other tolvaptan clinical trial.
18. Terminally ill or moribund condition with little chance of short term survival.
19. Serum creatinine \>3.5 mg/dL.
20. Serum sodium \<120 mEq/L with associated neurologic impairment, i.e. symptoms such as apathy, confusion, seizures.
21. Patients with progressive or episodic neurologic disease such as multiple sclerosis or history of multiple strokes.
22. Child-Pugh score greater than 10 (unless approved)
23. Patients receiving intravenous fluids at a rate greater than KVO (Keep Vein Open).
24. Hyponatremia due to lab artifacts
25. Patients receiving AVP or its analogs for treatment of any condition.
26. Patients receiving within 7 days of randomization, other medications for treatment of hyponatremia specifically: demeclocycline, lithium carbonate or urea
27. Patients likely requiring IV saline for correction of symptomatic or asymptomatic severe hyponatremia during the course of the study.
28. Severe pulmonary artery hypertension
29. Hyponatremia should not be the result of any medication that can safely be withdrawn
D: Inclusion Criteria:

* ≥ 18 years of age
* Daily oral dose of furosemide between ≥ 40 mg(or equivalent)
* Identified within 24 hours of presentation, defined for purposes of this study as the time of initial dose of intravenous loop diuretic
* Prior clinical HF diagnosis that was treated with oral loop diuretics for at least 1 month
* Admission for acute decompensated Heart Failure (HF) as determined by

  * dyspnea at rest or with minimal exertion
  * Brain Natriuretic Peptide (BNP) \> 400 or NTproBNP \> 2000 pg/mL

AND at least one of the following additional signs and symptoms:

* Orthopnea
* Peripheral edema
* Elevated JVP (Jugular Venous Pressure)
* Pulmonary rales
* Congestion on Chest X-ray
* No plan for revascularization, cardiac transplant, of ventricular assist device implantation, or other cardiac surgery within 60 days of randomization
* Signed informed consent

Exclusion Criteria:

* Serum Na \> 140 meq/L
* Received IV vasoactive treatment or ultra-filtration therapy for HF since initial presentation
* Treatment plan during current hospitalization includes IV vasoactive treatment or ultra-filtration for HF
* Systolic Blood Pressure (SBP)\<90mmHg
* Serum-Cr\>3.5mg/dl or currently undergoing renal replacement therapy

  . Known underlying liver disease
* Hemodynamically significant arrhythmias
* ACS(Acute coronary syndrome) within 4 weeks prior to study entry
* Active myocarditis
* Hypertrophic obstructive, restrictive, constrictive cardiomyopathy
* Severe stenotic valvular disease
* Complex congenital heart disease
* Constrictive pericarditis
* Clinical evidence of digoxin toxicity
* Need for mechanical hemodynamic support
* Terminal illness (other than heart failure) with expected survival time of less than 1 year
* History of adverse reaction to Tolvaptan
* Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
* Pregnant or breast-feeding
* Inability to comply with planned study procedures

Answer: B