None listed
Conditions
Interventions
Drug : Case: Entresto (R) 50mg or 100mg, 1T, qd, 360 days, take it orally
Control : Amosartan (R) 5/50 mg or 5/100 mg, Novrasc 2.5mg+ Cosca Tab 2.5mg, 1T, qd, 360 days, take it orally
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who understands the research protocol and has written a written consent form 2) Men and women over the age of 20 and who are not hospitalized 3) Patients diagnosed with hypertension or SBP 125 mmHg or higher (if never diagnosed with hypertension) 4) Patients with chronic severe aortic valve regurgitation (AR, Stage C1) (Ref. Otto et al.) - Patients with no symptoms due to AR - Patients with a left ventricular ejection fraction of 55% or more - Patients need to stay stable for at least four weeks with existing drugs - Vena contracta > 0.6cm - Regurgitant volume = 60mL/beat or the Effective regurgitant orifice area (EROA) = 0.3 cm2 4) New York Heart Association (NYHA) Functional Class
Exclusion criteria
Exclusion criteria: 1) History of hypersensitivity or allergy to clinical trial drugs or similar compounds, ARB/NEP inhibitors 2) a history of angioedema 3) Patients with an ascending aorta dilated of 55 mm or more 4) Patients with aortic valve failure due to hereditary aortic disease (Marfan syndrome, Ehlers-Danlos syndrome) 5) Patients with moderate to severe aortic valve stenosis 6) Patients with metal implants not suitable for claustrophobic or magnetic resonance imaging 7) history of acute heart failure within 6 weeks and dyspnea above NYHA II 8) symptomatic hypotension or SBP 5 mmol/L) 11) Symptoms and signs of cirrhosis with blood AST or ALT level more than twice the upper limit of normal (a history of hepatic encephalopathy, a history of esophageal varicose veins, and a history of symptomatic ascites) 12) Acute coronary syndrome, stroke, thoracic surgery, percutaneous coronary angioplasty were performed within 3 months 13) If aortic valve surgery is scheduled within the next 6 months 14) Severe mitral valve disease occurs 15) Patients with primary hyperaldosteronism 16) Women with a probability of pregnancy and without double contraception 17) women who is currently pregnant or nursing 18) When it is judged that there is a clinically significant abnormality in physical examination, diagnostic examination, electrocardiogram, etc. at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the left ventricular end-diastolic volume index level difference between two groups performed at the beginning and end of the stud | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in the regurgitant volume level difference between two groups performed at the beginning and end of the study;The difference in the effective regurgitant orifice area level difference between two groups performed at the beginning and end of the study;The difference in the left ventricular end-systolic volume level difference between two groups performed at the beginning and end of the study;The difference in the holodiastolic flow reversal in the proximal abdominal aorta and descending thoracic aorta level difference between two groups performed at the beginning and end of the study;The difference in the NT-proBNP level difference between two groups performed at the beginning and end of the study;The difference in the case of aortic valve replacement or repair operationdifference between two groups performed at the beginning and end of the study | — |
Countries
Korea, Republic of
Contacts
Public ContactEun Kyoung Kim
Samsung Medical Center
Outcome results
None listed