Effect of Fimasartan on Extended RAS and Vascular Functions in Patients With Type 2 Diabetes and Hypertension (FAoRAS)
Primary Purpose
Hypertension, Atherosclerosis, Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fimasartan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- ≥ 30 years old
- Type 2 diabetes by American Diabetes Association criteria
- HbA1c: 6.5% ≤ - < 10.0%
- Systolic blood pressure: 140 ≤ - < 180 mmHg or Diastolic blood pressure: 85 ≤ - < 110 mmHg
- Statin (-) or no change in low to moderate intensity statin [14] dose in recent 3 months
Exclusion Criteria:
- Contraindication of fimasartan or amlodipine
- History of RAS inhibitors (ACE inhibitors or ARBs) or calcium channel blockers in the previous 3 months
- Pregnant women, women with potential of pregnancy not using adequate contraception method as evaluated by the investigator, lactating women
- Type 1 diabetes or diabetes secondary to chronic pancreatitis or to pancreatectomy
- Confirmed cardiovascular disease (acute coronary syndrome, stroke, or transient ischemic attack) within 3 months of screening
- Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)
- Chronic kidney disease (serum creatinine > 2.0 mg/dL)
- Hyperkalemia serum potassium >5.0 mEq/L
- Any previous cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fimasartan
Amlodipine
Arm Description
- Fimasartan group: Fimasartan, 60 mg once a day, oral administration
- Comparator group: Amlodipine, 5 mg once a day, oral administration
Outcomes
Primary Outcome Measures
Angiotensin(1-7)
Changes of serum angiotensin(1-7) at week 12 from baseline
Secondary Outcome Measures
Blood pressure
Change in blood pressure from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
ACE-2
Change in ACE-2 from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
ACE
Change in ACE from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Renin
Change in renin from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
angiotensin
Change in angiotensin from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
atherosclerosis
Change in atherosclerosis from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Muscle mass
Change in muscle mass from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Fat mass
Change in fat mass from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
HbA1c
Change in HbA1c from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Full Information
NCT ID
NCT05173025
First Posted
December 27, 2021
Last Updated
August 10, 2023
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05173025
Brief Title
Effect of Fimasartan on Extended RAS and Vascular Functions in Patients With Type 2 Diabetes and Hypertension
Acronym
FAoRAS
Official Title
Effect of Fimasartan or Amlodipine on Extended Renin-angiotensin System in Patients With Type 2 Diabetes and Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, we will assess the change of extended renin-angiotensin system including serum ACE-2 and angiotensin(1-7) levels and subclinical atherosclerosis after using fimasartan (an ARB), compared to amlodipine in hypertensive patients with T2DM.
Detailed Description
Several clinical trials aimed at studying the benefits of RAS blockade in the diabetic complications. HOPE, RENAAL, IRMA2, IDNT, ONTARGET studies proved that ACE inhibitors or ARBs reduced the risk of diabetic complications.
Recent studies proved that fimasartan, one of the ARBs, stabilizes the activity of renin-angiotensin system. However, understanding the change in concentration of serum ACE, ACE-2, angiotensin(1-7), and angiotensin-II should help clinicians select more appropriate drug between ACE inhibitors and ARBs with clear evidence. Moreover, since RAS antagonists are the first-line drugs for antihypertensive therapy in patients with T2DM, it is meaningful to understand the change of RAS-related factors in serum after using the drugs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Atherosclerosis, Diabetes Mellitus, Type 2, Renin Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fimasartan
Arm Type
Experimental
Arm Description
- Fimasartan group: Fimasartan, 60 mg once a day, oral administration
Arm Title
Amlodipine
Arm Type
Active Comparator
Arm Description
- Comparator group: Amlodipine, 5 mg once a day, oral administration
Intervention Type
Drug
Intervention Name(s)
Fimasartan
Other Intervention Name(s)
Kanarb
Intervention Description
- Fimasartan group: fimasartan, 60 mg once a day, oral administration
Primary Outcome Measure Information:
Title
Angiotensin(1-7)
Description
Changes of serum angiotensin(1-7) at week 12 from baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Change in blood pressure from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Time Frame
12 weeks
Title
ACE-2
Description
Change in ACE-2 from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Time Frame
12 weeks
Title
ACE
Description
Change in ACE from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Time Frame
12 weeks
Title
Renin
Description
Change in renin from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Time Frame
12 weeks
Title
angiotensin
Description
Change in angiotensin from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Time Frame
12 weeks
Title
atherosclerosis
Description
Change in atherosclerosis from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Time Frame
12 weeks
Title
Muscle mass
Description
Change in muscle mass from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Time Frame
12 weeks
Title
Fat mass
Description
Change in fat mass from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Time Frame
12 weeks
Title
HbA1c
Description
Change in HbA1c from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 30 years old
Type 2 diabetes by American Diabetes Association criteria
HbA1c: 6.5% ≤ - < 10.0%
Systolic blood pressure: 140 ≤ - < 180 mmHg or Diastolic blood pressure: 85 ≤ - < 110 mmHg
Statin (-) or no change in low to moderate intensity statin [14] dose in recent 3 months
Exclusion Criteria:
Contraindication of fimasartan or amlodipine
History of RAS inhibitors (ACE inhibitors or ARBs) or calcium channel blockers in the previous 3 months
Pregnant women, women with potential of pregnancy not using adequate contraception method as evaluated by the investigator, lactating women
Type 1 diabetes or diabetes secondary to chronic pancreatitis or to pancreatectomy
Confirmed cardiovascular disease (acute coronary syndrome, stroke, or transient ischemic attack) within 3 months of screening
Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)
Chronic kidney disease (serum creatinine > 2.0 mg/dL)
Hyperkalemia serum potassium >5.0 mEq/L
Any previous cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soo Lim, MD, PhD
Phone
01097662706
Email
limsoo@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Lim, MD, PHD
Phone
82-31-787-7035
Email
limsoo@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Soo Lim, MD, PHD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Fimasartan on Extended RAS and Vascular Functions in Patients With Type 2 Diabetes and Hypertension
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