Effect of Tolvaptan on Cognitive Function in Cirrhosis

Completed · Phase 3

Conditions studied: Cirrhosis, Hepatic Encephalopathy, Hyponatremia

In brief

Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related quality of life in cirrhotic patients with hyponatremia

Key facts

Study ID

NCT01556646

Run by

Hunter Holmes Mcguire Veteran Affairs Medical Center

People needed

25

Starts

2011-04-01

Expected to finish

2013-06-01

Last updated by the study team

2014-02-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cirrhosis diagnosed by liver biopsy or radiological evidence of nodular cirrhotic liver or varices on endoscopy or laboratory features (platelet count <150,000 with an AST/ALT ratio >1).
• History of HE controlled on lactulose and/or rifaximin
• Last HE episode >2 months prior to enrollment and <2 episodes within 6 months
• Mini-mental status exam score ≥25
• Serum sodium <130mg/dl within the last 14 days and the day of enrollment
• Availability of a caregiver
• Able to undergo MR of the head

You may not qualify if…

• Uncontrolled HE manifested by MMSE <25
• Alcohol abuse within 3 months
• Illicit drug use within 3 months
• Psychoactive drug use other than regularly scheduled anti-depressants or methadone.
• Contraindication to MR examination (see attached MRI Safety Form)
• Placement of a transjugular intra-hepatic portosystemic shunt (TIPS)
• Creatinine Clearance less than 10 ml/min or undergoing hemodialysis
• HIV infection
• Use of azole medications
• Pregnancy
• Current use of tolvaptan, hypertonic saline or other medical therapies for hyponatremia

Where it is running

• Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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