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ACE Inhibitor
Lisinopril for Liver Cancer
Phase 2
Recruiting
Led By Mazen Noureddin
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights
Study Summary
This trial is testing if lisinopril can help prevent the progression of non-alcoholic fatty liver disease, which can lead to liver cancer.
Who is the study for?
Adults diagnosed with nonalcoholic steatohepatitis (NASH) and liver fibrosis, who have not used certain blood pressure medications recently, can join this trial. They must have a stable blood count, kidney function, and be willing to use contraception if of childbearing potential. Exclusions include pregnant or breastfeeding women, those with severe liver disease or recent weight reduction surgery, heavy drinkers, and individuals on unstable doses of certain supplements or diabetes medication.Check my eligibility
What is being tested?
The RELIEF-NAFLD study is testing whether the blood pressure medication Lisinopril can prevent worsening of non-alcoholic fatty liver disease (NAFLD) and reduce the risk of developing liver cancer. Participants will undergo various assessments including questionnaires, imaging tests like MRI and ultrasonography for fat in the liver as well as biospecimen collection to monitor effects.See study design
What are the potential side effects?
Lisinopril may cause side effects such as coughing, dizziness due to low blood pressure especially after standing up quickly (orthostatic hypotension), headaches, fatigue and possibly allergic reactions in some people.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in PRO-C3 values
Secondary outcome measures
Change in Fibrosis-4 score
Change in PC3X (cross-linked multimeric PRO-C3)
Change in inflammatory markers (caspase cleaved cytokeratin 18, NF-kappaB, TGF-beta, TNF-alpha, IL6 and IL8)
+2 moreOther outcome measures
Change in homeostatic assessment of glycosylated hemoglobin
Change in markers of liver injury and function: alanine aminotransferase, aspartate aminotransferase, bilirubin, and alkaline phosphatase
Change in serum lipid profiles
+3 moreSide effects data
From 2009 Phase 4 trial • 252 Patients • NCT003918469%
Cardiac Failure
4%
Myocardial Infarction
2%
Ventricular Tachycardia
2%
Anaemia
2%
Chronic Obstructive Pulmonary Disease
2%
Syncope
2%
Angina Pectoris
2%
Artial Fibrillation
2%
Dyspnoea
2%
Hyperkalaemia
2%
Pneumonia
1%
Cerebral Infarction
1%
Dyspepsia
1%
Duodenal Ulcer Haemorrhage
1%
Confusional State
1%
Polymyalgia Rheumatica
1%
Cerebrovascular Accident
1%
Concussion
1%
Endocarditis
1%
Right Ventricular Failure
1%
Hepatic Failure
1%
Diverticulitis
1%
Multi-Organ Failure
1%
Aortic Stenosis
1%
Intestinal Ischaemia
1%
Spinal Fracture
1%
Back Pain
1%
Bladder Neoplasm
1%
Blood Electrolytes Abnormal
1%
Bradycardia
1%
Muscular Weakness
1%
Osteoarthritis
1%
Angina Unstable
1%
B-Cell Lymphoma
1%
Bleeding Varicose Vein
1%
Bronchitis
1%
Carotid Artery Stenosis
1%
Intervertebral Disc Compression
1%
Pulmonary Odema
1%
Respiratory Tract Infection Viral
1%
Septic Shock
1%
Peripheral Ischaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Guided by NT-proBNP
Not Guided by NT-proBNP
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prevention (lisinopril)Experimental Treatment7 Interventions
Patients receive lisinopril PO QD for 24 weeks in absence of unacceptable toxicity. Patients undergo transient elastography during screening and on study. Patients also undergo blood sample collection on study and may undergo a PDFF MRI and MRE on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1730
Lisinopril
2012
Completed Phase 4
~39510
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,662 Previous Clinical Trials
40,926,028 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Mazen NoureddinPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
Ju Dong YangPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions to drugs that are similar to lisinopril.You have a history of serious liver problems, such as fluid buildup in the abdomen (ascites), confusion caused by liver damage (hepatic encephalopathy), or bleeding from swollen blood vessels in the esophagus (variceal bleeding).You are currently taking lithium medication.You have had liver diseases in the past, like hepatitis or liver damage from alcohol or certain medications.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (lisinopril)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are actively involved in this research endeavor?
"Affirmative. According to the clinicaltrials.gov entry, this experiment was initially published on April 1st 2021 and recently updated as of November 8th 2022. It is presently seeking 45 participants at 6 separate sites."
Answered by AI
Are there still vacancies for individuals to join this examination?
"As corroborated by data on clinicaltrials.gov, the recruitment phase of this experiment is ongoing. This trial was first published to the site on April 1st 2021 and updated just recently on November 8th 2022."
Answered by AI
In what medical applications is Lisinopril commonly employed?
"Lisinopril is regularly prescribed to mitigate diabetic nephropathy, but it can also successfully address myocardial infarction, migraine prophylaxis and hypertensive disease."
Answered by AI
Are there any additional investigations related to the use of Lisinopril?
"Lisinopril was initially researched in 2016 at the Royal Glamorgan Hospital, with 303 trials now having been completed. Eight clinical studies are currently underway across a variety of locations, including Los Angeles, California."
Answered by AI
To what degree is Lisinopril a risk to patients' health?
"With Phase 2 trials indicating some promising safety data but no efficacy, our team rated Lisinopril with a score of 2."
Answered by AI
At how many venues is the clinical trial being administered?
"Participants are being sought out from the Cedars Sinai Medical Center in Los Angeles, California, Cedars-Sinai Cancer - Tarzana in Tarzana, Illinois and Northwestern University in Chicago, North carolina. Additionally 6 more clinical trial sites have been opened for patient enrolment."
Answered by AI
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