Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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The aim of this current study was to assess the therapeutic effects of perindopril and telmisartan for hypertensive patients with NAFLD and make comparison between the therapeutic effects of these two kind of drugs. This study is a randomized parallel control clinical trial which would be carried out in Nanfang Hospital, Southern Medical University. About one hundred and eighty patients would be randomly assigned to perindopril,telmisartan and amlodipine three groups.

Detailed Description
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Inclusion criteria: 18-70 years old patients who were diagnosed with mild-moderate hypertension and NAFLD; The patients did not take ACEIs or ARBs drugs six weeks before the inclusion; Patients agreed to participate in the trial and signed the informed consent. Exclusion criteria: There are no coexisting causes for chronic liver disease, such as viral, alcoholic,drug-induced and autoimmune liver diseases; Patients with diabetes mellitus; Patients with serious primary diseases; Patients with mental disorder or can not take the medicine regularly; Pregnancy and nursing mothers; Allergic constitution or intolerance to ACEIs or ARBs drugs. Outcome measures include Cap value of FibroScan,angiotensin II,IL-18，IL-1β,aminotransferase,lipids and HOMA-IR.

Official Title
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Evaluation of Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial

Conditions
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Nonalcoholic Fatty Liver Disease (NAFLD)

Intervention / Treatment
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* Drug: Perindopril
* Drug: Telmisartan
* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years old patients who were diagnosed with mild-moderate hypertension and NAFLD; The patients did not take ACEIs or ARBs drugs six weeks before the inclusion; Patients agreed to participate in the trial and signed the informed consent. Exclusion Criteria: There are no coexisting causes for chronic liver disease, such as viral, alcoholic,drug-induced and autoimmune liver diseases; Patients with diabetes mellitus; Patients with serious primary diseases; Patients with mental disorder or can not take the medicine regularly; Pregnancy and nursing mothers; Allergic constitution or intolerance to ACEIs or ARBs drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perindopril<br>Perindopril 4mg qd taken in the morning; | Drug: Perindopril<br>* Perindopril is a kind of angiotensin converting enzyme inhibitors (ACEIs) which has been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.<br>* Other names: Perindopril; brand name: Acertil, serial number:H20034053;|
| Experimental: Telmisartan<br>Telmisartan 80mg qd taken in the morning; | Drug: Telmisartan<br>* Telmisartan is a kind of angiotensin receptor blockers (ARBs) which has also been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.<br>* Other names: Telmisartan; brand name: Micardis, serial number:J20090089;|
| Placebo Comparator: Amlodipine<br>Amlodipine；5mg qd taken in the morning. | Drug: Amlodipine<br>* Amlodipine is also a kind of widely used first-line drugs for the treatment of hypertension, and there is no evidence showing that it is effective for NAFLD.<br>* Other names: Amlodipine；5mg qd taken in the morning.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cap value of FibroScan （dB/m） | FibroScan examination would be performed in all patients 48 weeks after administration of the drugs, and Cap value of FirbroScan will be recorded. | 48 weeks after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiotensin II |  | 12, 24, 48 weeks after the treatment | 
| IL-18，IL-1β |  | 12, 24, 48 weeks after the treatment | 
| aminotransferase |  | 12, 24, 48 weeks after the treatment | 
| lipids |  | 12, 24, 48 weeks after the treatment | 
| HOMA-IR | homeostasis model assessment of insulin resistance (HOMA-IR) | 12, 24, 48 weeks after the treatment | 
| computed tomography value of liver |  | 48 weeks after the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perindopril,Telmisartan, Efficacy, NAFLD