NCT05173025

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

Effect of Fimasartan or Amlodipine on Extended Renin-angiotensin System in Patients With Type 2 Diabetes and Hypertension

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Atherosclerosis
• Diabetes Mellitus, Type 2
• Renin Hypertension

Interventions

Type	Name	Description
DRUG	Fimasartan	\- Fimasartan group: fimasartan, 60 mg once a day, oral administration

Timeline

• Start date: 2018-01-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-12-29
• Last updated: 2023-08-14

Locations

1 site across 1 country: South Korea