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Calcium-Phosphorus Regulation Therapy on Heart Valve Disease

StatusRecruiting
PhasePhase 4
Started2024-03-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 28, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
The goal of this clinical trial is to learn if calcium-phosphorus regulation therapy can slow the progression of heart valve calcification in patients with degenerative heart valve disease and chronic kidney disease (CKD). The main questions it aims to answer are: * Does Sevelamer lower the progression of heart valve calcification compared to calcium carbonate over 12 months? * What are the impacts of calcium-phosphorus regulation therapy on major cardiovascular events such as heart failure, cardiovascular death, and the need for valve surgery? Researchers will compare Sevelamer to calcium carbonate to see if Sevelamer is more effective in reducing heart valve calcification. Participants will: * Take Sevelamer or calcium carbonate daily for 12 months. * Undergo echocardiography and CT scans at baseline and after 12 months to assess heart valve calcification. * Attend follow-up visits at 3, 6, 9, and 12 months to monitor blood tests and adjust treatment as needed.
Trial Details
NCT Number NCT06660524
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions Degenerative Heart Valve Disease, Heart Valve Calcification, Chronic Kidney Disease(CKD), Calcium-Phosphorus Metabolism Disorders
Enrollment 196 participants
Start Date 2024-03-01
Primary Completion 2025-06 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-10-28