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

Hypertension Clinical Trial

— FAoRAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05173025
• Other study ID #: B-1606-351-003
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Seoul National University Bundang Hospital
• Contact: Soo Lim, MD, PhD
• Phone: 01097662706
• Email: limsoo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiotensin(1-7)	Changes of serum angiotensin(1-7) at week 12 from baseline	12 weeks
Secondary	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	12 weeks
Secondary	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	12 weeks
Secondary	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	12 weeks
Secondary	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	12 weeks
Secondary	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	12 weeks
Secondary	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	12 weeks
Secondary	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	12 weeks
Secondary	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	12 weeks
Secondary	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	12 weeks