Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease (NF-NAFLD)

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 4

Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)

Treatments: Drug: Telmisartan; Drug: Perindopril; Drug: Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT02213224

NAFLD20140805

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups, including a placebo group

Perindopril

Experimental group

Description:

Perindopril 4mg qd taken in the morning;

Treatment:

Drug: Perindopril

Telmisartan

Experimental group

Description:

Telmisartan 80mg qd taken in the morning;

Treatment:

Drug: Telmisartan

Amlodipine

Placebo Comparator group

Description:

Amlodipine；5mg qd taken in the morning.

Treatment:

Drug: Amlodipine