Clinical trial NCT05173025: Effect of Fimasartan on Extended RAS and Vascular Functions in Patients With Type 2 Diabetes and Hypertension
Official title: Effect of Fimasartan or Amlodipine on Extended Renin-angiotensin System in Patients With Type 2 Diabetes and Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypertension
Atherosclerosis
Diabetes Mellitus, Type 2
Renin Hypertension
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Angiotensin(1-7)
timeFrame: 12 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 12 weeks
measure: ACE-2
timeFrame: 12 weeks
measure: ACE
timeFrame: 12 weeks
measure: Renin
timeFrame: 12 weeks
measure: angiotensin
timeFrame: 12 weeks
measure: atherosclerosis
timeFrame: 12 weeks
measure: Muscle mass
timeFrame: 12 weeks
measure: Fat mass
timeFrame: 12 weeks
measure: HbA1c
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References: