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

Primary Purpose

Nonalcoholic Fatty Liver Disease (NAFLD)

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Perindopril
Telmisartan
Amlodipine
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease (NAFLD) focused on measuring Perindopril,Telmisartan, Efficacy, NAFLD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Perindopril

Telmisartan

Amlodipine

Arm Description

Perindopril 4mg qd taken in the morning;

Telmisartan 80mg qd taken in the morning;

Amlodipine；5mg qd taken in the morning.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Angiotensin II
IL-18，IL-1β
aminotransferase
lipids
HOMA-IR
homeostasis model assessment of insulin resistance (HOMA-IR)
computed tomography value of liver

Full Information

First Posted
August 6, 2014
Last Updated
August 8, 2014
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02213224
Brief Title
Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease
Acronym
NF-NAFLD
Official Title
Evaluation of Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease (NAFLD)
Keywords
Perindopril,Telmisartan, Efficacy, NAFLD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perindopril
Arm Type
Experimental
Arm Description
Perindopril 4mg qd taken in the morning;
Arm Title
Telmisartan
Arm Type
Experimental
Arm Description
Telmisartan 80mg qd taken in the morning;
Arm Title
Amlodipine
Arm Type
Placebo Comparator
Arm Description
Amlodipine；5mg qd taken in the morning.
Intervention Type
Drug
Intervention Name(s)
Perindopril
Other Intervention Name(s)
Perindopril; brand name: Acertil, serial number:H20034053
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Telmisartan
Other Intervention Name(s)
Telmisartan; brand name: Micardis, serial number:J20090089
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Other Intervention Name(s)
Amlodipine；5mg qd taken in the morning.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cap value of FibroScan （dB/m）
Description
FibroScan examination would be performed in all patients 48 weeks after administration of the drugs, and Cap value of FirbroScan will be recorded.
Time Frame
48 weeks after the treatment
Secondary Outcome Measure Information:
Title
Angiotensin II
Time Frame
12, 24, 48 weeks after the treatment
Title
IL-18，IL-1β
Time Frame
12, 24, 48 weeks after the treatment
Title
aminotransferase
Time Frame
12, 24, 48 weeks after the treatment
Title
lipids
Time Frame
12, 24, 48 weeks after the treatment
Title
HOMA-IR
Description
homeostasis model assessment of insulin resistance (HOMA-IR)
Time Frame
12, 24, 48 weeks after the treatment
Title
computed tomography value of liver
Time Frame
48 weeks after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Side Liu, MD,PhD
Phone
+86 020 61641537
Email
liuside2011@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Side Liu, MD,PhD
Organizational Affiliation
Department of Gastroenterology, Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yue Li, MD
Phone
+86-15975537291
Email
liyue_1989919@126.com
First Name & Middle Initial & Last Name & Degree
Side Liu, MD.PhD
First Name & Middle Initial & Last Name & Degree
Yue Li, MD
First Name & Middle Initial & Last Name & Degree
Xu Li, MD
First Name & Middle Initial & Last Name & Degree
Zelong Han, MD
First Name & Middle Initial & Last Name & Degree
Wen Xu, MM
First Name & Middle Initial & Last Name & Degree
Yubin Guo, MM
First Name & Middle Initial & Last Name & Degree
Feng Xiong, MD

12. IPD Sharing Statement

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Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease

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