Effect of Fimasartan on Extended RAS and Vascular Functions in Patients With Type 2 Diabetes and Hypertension (FAoRAS)

Seoul National University

Status and phase: Enrolling; Phase 4

Conditions: Hypertension; Renin Hypertension; Diabetes Mellitus, Type 2; Atherosclerosis

Treatments: Drug: Fimasartan

Study type: Interventional

Funder types: Other

Identifiers

NCT05173025

B-1606-351-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups

Fimasartan

Experimental group

Description:

- Fimasartan group: Fimasartan, 60 mg once a day, oral administration

Treatment:

Drug: Fimasartan

Amlodipine

Active Comparator group

Description:

- Comparator group: Amlodipine, 5 mg once a day, oral administration

Treatment:

Drug: Fimasartan