RecruitingPhase 4NCT06660524

Calcium-Phosphorus Regulation Therapy on Heart Valve Disease

Clinical Study on the Influence of Calcium and Phosphorus Regulation Therapy on Valvular Heart Disease.

Sponsor

China National Center for Cardiovascular Diseases

Enrollment

196 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease(CKD)Degenerative Heart Valve Disease Heart Valve Calcification Calcium-Phosphorus Metabolism Disorders

Summary

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.

Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether treating high phosphorus levels in the blood — a problem tied to kidney disease — can slow the calcification (hardening) of heart valves and reduce disease progression in people with both kidney disease and degenerative heart valve disease. **You may be eligible if...** - You are 50 years or older - You have degenerative heart valve disease confirmed by ultrasound, with calcification - Your kidney function is reduced (filtration rate below 60 mL/min) - Your blood phosphorus level is elevated (above 4.5 mg/dL or 1.45 mmol/L) **You may NOT be eligible if...** - Your valve disease is caused by rheumatic fever or a birth defect (not degenerative) - Your valve disease requires surgery or an interventional procedure soon - You have a life expectancy of less than 1 year - You have abnormal parathyroid function - You are expected to start dialysis within 6 months - You have cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSevelamer

Sevelamer is administered orally, and the administration strategy is implemented in accordance with the 2017 KDIGO Guideline and the 2019 Chinese Guidelines for the Diagnosis and Treatment of Mineral and Bone Disorders in Chronic Kidney Disease.

DRUGCalcium carbonate

Calcium carbonate is administered orally, and the administration strategy is implemented in accordance with the 2017 KDIGO Guideline and the 2019 Chinese Guideline for the Diagnosis and Treatment of Mineral and Bone Disorders in Chronic Kidney Disease.

Locations(1)

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

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NCT06660524

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