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

Seoul National University Bundang Hospital42 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypertension Atherosclerosis Diabetes Mellitus, Type 2 Renin Hypertension

Interventions

FimasartanDRUG

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

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

Angiotensin(1-7)

Changes of serum angiotensin(1-7) at week 12 from baseline

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 12 weeks

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

Time frame: 12 weeks

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

Time frame: 12 weeks

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

Time frame: 12 weeks

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

Time frame: 12 weeks

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

Time frame: 12 weeks

Muscle mass

Central Contacts

Soo Lim, MD, PhD

CONTACT

01097662706 limsoo@snu.ac.kr

Data from ClinicalTrials.gov

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