Efficacy of Sildenafil in the Improvement of Cognition and Quality of Life in Patients With Cirrhosis of Liver. A Proof of Concept Study.

NCT02028429 | Unknown Phase 1 DMC

• 1 other identifier: Hepatology PGIMER 2012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the efficacy of Sildenafil (a 5-phosphodiesterase inhibitor) as a means to improve the cognitive impairment encountered in patients of minimal hepatic encephalopathy (MHE) as proposed in different studies. This study would also assess the role of improvement of cognition as a means of improvement in quality of life.The patients will receive Sildenafil or no treatment for 4 weeks. This study may prove and provide important therapeutic strategy for cognition impairment in patients with MHE.

Conditions

Hepatic Encephalopathy.

Keywords

Minimal Hepatic Encephalopathy (MHE); Psychometric Hepatic Encephalopathy Score (PHES); Sickness Impact Profile (SIP); Model for End-stage Liver Disease (MELD); Child-Turcotte-Pugh score (CTP)

Outcome Measures

Primary Outcomes (2)

• Cognition( PHES)

  Improvement of impairment in cognition as assessed by PHES (Psychometric Hepatic Encephalopathy Score) in patients of MHE (Minimal hepatic Encephalopathy) by means of pharmacological intervention by sildenafil (a PDE-5 inhibitor) before and after treatment.

  4 weeks

• QOL(SIP)

  To study the impact of treatment with sildenafil administration on the improvement in health-related quality-of-life of patients as assessed by sickness impact profile (SIP) before and after treatment.

  4 weeks

Secondary Outcomes (2)

• CTP and MELD score before and after treatment with Sildenafil.

  4 weeks

• Blood Ammonia and Interleukin-6 levels before and after treatment with Sildenafil.

  4 weeks

Study Arms (2)

Intervention 'Sildenafil'.

EXPERIMENTAL

MHE patient receiving Sildenafil. Intervention: Sildenafil Drug Dosage: 25 mg once a day for one week followed by 25 mg twice daily for two weeks then 25 mg thrice daily for one week.

Drug: Sildenafil.

'No sildenafil'

NO INTERVENTION

Control Arm: MHE patients not receiving SIldenafil Intervention.Followed up for 4 weeks.

Interventions

Sildenafil. DRUG

Arm 1 :Sildenafil Drug Dosage: 25 mg once a day for one week followed by 25 mg twice daily for two weeks then 25 mg thrice daily for one week.

Also known as: Suhagra.

Intervention 'Sildenafil'.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MHE will be defined by PHES ≤-5 and normal MMSE score of ≥24.

You may not qualify if:

• Patients unable to give informed consent.
• H/O alcohol intake during last 12 weeks.
• Significant comorbid illness such as heart disease, respiratory disease, or renal failure.
• Any neurological disease such as Alzheimer disease, Parkinson's disease, stroke, non- hepatic metabolic encephalopathy's.
• Any anatomical deformities or disease of the penis such as Peyronie's disease.
• Patients having psychiatric illness and taking treatment with antidepressant, sedative or neuroleptics.
• Patients who start taking alcohol during the study period will be excluded.
• Patients taking vasodilators such as nitrates.
• Hepatocellular carcinoma.
• Recent history of upper GI bleed in last 6 weeks.
• Active ongoing infection.
• Electrolyte abnormality precipitating MHE.
• Color vision abnormalities.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education & Research Chandigarh

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Radha K Dhiman, MD, DM, FACG

  PGIMER Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2013
• First Posted: January 7, 2014
• Study Start: July 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

IN (1)