Study of Calcium-Phosphorus Regulation Therapy Using Sevelamer or Calcium Carbonate to Slow Heart Valve Calcification in Patients with Degenerative Heart Valve Disease and Chronic Kidney Disease

What this Trial Is About

Researchers are evaluating whether calcium-phosphorus regulation therapy can slow the progression of heart valve calcification in people with degenerative heart valve disease and chronic kidney disease CKD. The study aims to compare the effects of Sevelamer and calcium carbonate over 12 months to see which treatment better reduces heart valve calcification and impacts major cardiovascular events like heart failure, cardiovascular death, and the need for valve surgery. Participants will take either Sevelamer or calcium carbonate orally according to established guidelines for managing mineral and bone disorders in CKD. The treatment lasts for 12 months, with dosing strategies based on the 2017 KDIGO Guideline and the 2019 Chinese Guideline. The study includes follow-up visits at 3, 6, 9, and 12 months to monitor blood tests and adjust treatment as needed. During the study, participants undergo echocardiography and CT scans at the start and after 12 months to assess heart valve calcification. Researchers will monitor blood phosphorus levels and kidney function regularly. The main outcome measured is the change in valve calcification score on CT scans from baseline to one year. Secondary outcomes include major cardiovascular events during the same period. The trial is randomized and open-label, with total participation lasting one year.

Calcium-Phosphorus Regulation Therapy on Heart Valve Disease