Status:
UNKNOWN
Randomized, Open-label Trial of Inhibitory Effect of Evogliptin on Progression of CAVD
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
REDNVIA Co., Ltd.
Conditions:
CAVD
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess an inhibitory effect of Evogliptin on the progression of mild-to-moderate aortic stenosis in patients with T2DM and calcific aortic stenosis.
Detailed Description
Despite a lot of clinician's efforts to develop an effective medical treatment of calcific aortic valve disease (CAVD) for decades, there is no scientifically-proved medical treatment yet. Since the p...
Eligibility Criteria
Inclusion
- Male and female aged 19 years or older
- Subjects who were diagnosed with type 2 diabetes mellitus and being treated with oral hypoglycemic drugs
- Subjects whose Doppler echocardiography or Heart CT performed within 8 weeks prior to or during Screening Visit (Visit 1) is satisfying any of the followings:
- Doppler echocardiogrphy (aortic valve calcification and/or hypertrophy with aortic peak velocity≥2.0 m/s); or
- Heart CT (aortic valve calcium score≥300 AU)
- Subjects who decided to take part in this study on his/her own volition after listening to the details of this study
Exclusion
- Subjects with severe aortic valve stenosis (aortic peak velocity\>4.0 m/s, mean pressure gradient \>40 mmHg, or aortic valve area≤0.75 cm2)
- Subjects with left ventricular ejection fraction \< 40%
- Heart failure patients: Subjects with heart failure of NYHA functional class II-IV
- Subjects with an estimated glomerular filtration rate (eGFR) of \<30ml
- Subjects with type 1 diabetes or diabetic ketoacidosis
- Subjects with serious hypersensitivity to DPP-4 inhibitors
- Subjects who have received/are receiving any of the following medication therapies:
- Vitamin K
- Calcium supplement (or osteoporosis medication)
- Subjects whose aortic valve stenosis is not caused by degenerative or bicuspid valve disease (e.g. rheumatic valve disease)
- Subjects who have received or are expected to receive (as of Visit 1) aortic valve surgery during the study.
- Subjects for whom a two-year clinical course investigation is not possible due to malignant tumor or cerebrovascular disease
- Pregnant or lactating women
- Women of childbearing potential who are sexually active and do not agree to use proper contraception during the study
- Proper contraception means physical barrier method including condom, contraceptive diaphragm or cervix cap. The use of contraceptive or oral contraceptive containing hormones that may induce drug-drug interaction with the investigational product is not allowed during the study (with the exception of an oral contraceptive administered to cure menopausal symptoms, only if the dosage has been consistent for the past 8 weeks)
- Any other subjects deemed not eligible for this study by an investigator
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT04521452
Start Date
September 1 2020
End Date
September 1 2024
Last Update
August 20 2020
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea