FAoRAS: Effect of Fimasartan on Extended RAS and Vascular Functions in Patients With Type 2 Diabetes and Hypertension
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fimasartan - Fimasartan group: Fimasartan, 60 mg once a day, oral administration |
Drug: Fimasartan
- Fimasartan group: fimasartan, 60 mg once a day, oral administration
Other Names:
|
| Active Comparator: Amlodipine - Comparator group: Amlodipine, 5 mg once a day, oral administration |
Drug: Fimasartan
- Fimasartan group: fimasartan, 60 mg once a day, oral administration
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Angiotensin(1-7) [12 weeks]
Changes of serum angiotensin(1-7) at week 12 from baseline
Secondary Outcome Measures
- Blood pressure [12 weeks]
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 [12 weeks]
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 [12 weeks]
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 [12 weeks]
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 [12 weeks]
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 [12 weeks]
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 [12 weeks]
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 [12 weeks]
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 [12 weeks]
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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Bundang Hospital | Seongnam | Gyeonggi | Korea, Republic of | 463-707 |
Sponsors and Collaborators
- Seoul National University Bundang Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B-1606-351-003