Please select the eligibility criteria that correspond to the clinical trial below.
Title: Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver
Brief Summary: Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver.

Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).


Options:
A: 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
B: Inclusion Criteria:

* Patients with cirrhosis of the liver.
* Patients resistant to the effects of diuretics, intolerant of diuretics or otherwise unsuitable for treatment with diuretics according to the judgement of the investigator.
* Patients with recurrent ascites having undergone both of the following:

  * therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of = or \> 4 litres of fluid.
  * at least one other therapeutic paracentesis in the previous 3 months.

Exclusion Criteria:

* Patients with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt.
* Known hepatocellular carcinoma.
* Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
* Patients previously exposed to satavaptan in the past 12 months.
C: Inclusion Criteria:

* Participants with cirrhosis of the liver
* Participants with clinically evident ascites primarily managed by diet and/or diuretics
* Stable treatment of ascites for at least the previous 2 weeks without paracentesis
* Participants having undergone no more than one therapeutic paracentesis in the previous 6 months.

Exclusion Criteria:

* Participants with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt
* Known hepatocellular carcinoma
* Participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
* Participants previously exposed to satavaptan in the past 12 months
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: C