UnknownPhase 4

Randomized, Open-label Trial of Inhibitory Effect of Evogliptin on Progression of CAVD

South Korea218 participantsStarted 2020-09

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. Subjects who decided to take part in this study on his/her own volition after listening to the details of this study

Exclusion criteria

✕. 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:
✕. Subjects whose aortic valve stenosis is not caused by degenerative or bicuspid valve disease (e.g. rheumatic valve disease)

What they're measuring

Change in aortic valve calcium volume at week 96 from baseline

Timeframe: 96 weeks

Trial details

NCT IDNCT04521452

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09

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