Effect of Tolvaptan on Cognitive Function in Cirrhosis

Effects of Tolvaptan on Cognitive Function, Brain Metabolism and Quality of Life in Hyponatremic Cirrhotics With Hepatic Encephalopathy: A Prospective Clinical Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01556646

Enrollment

Registered

2012-03-16

Start date

2011-04-30

Completion date

2013-06-30

Last updated

2014-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Hepatic Encephalopathy, Hyponatremia

Keywords

Cirrhosis, Hepatic Encephalopathy, Hyponatremia, Brain MRI, Health-related quality of life, cognitive function

Brief summary

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

Detailed description

Baseline assessment will include a 1. battery of eight cognitive tests 2. Health related quality of life 3. MRI head evaluating MR spectroscopy and diffusion tensor imaging Patients will then be given tolvaptan 15-30mg qd for 14 days after which the tests will be repeated. During the first 3 days of tolvaptan administration, patients will be admitted and serum sodium will be drawn every 8 hours. 24 hr urine collection will also be performed. Between the initiation and end of tolvaptan, patients will be seen at least every 3-5 days in between. Participation will be terminated in case patients get transplanted or develop overt HE in between.

Interventions

DRUGTolvaptan

15 to 30mg qd titrated to sodium concentration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Cognitive performance	14 days

Secondary

Measure	Time frame
Brain MR Spectroscopy	14 days
Brain Diffusion Tensor Imaging	14 days
Health-related Quality of Life	14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026