Calcium-Phosphorus Regulation Therapy on Heart Valve Disease
Recruiting now · Phase 4
Conditions studied: Degenerative Heart Valve Disease, Heart Valve Calcification, Chronic Kidney Disease(CKD), Calcium-Phosphorus Metabolism Disorders
In brief
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.
Key facts
- Study ID
- NCT06660524
- Run by
- China National Center for Cardiovascular Diseases
- People needed
- 196
- Starts
- 2024-03-01
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-10-28
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 50 years old.
- Degenerative valvular heart disease clearly diagnosed by ultrasound or clinical history with calcification manifestation (including no stenosis or insufficiency due to calcification, mild, moderate and severe stenosis and insufficiency caused by calcification).
- Glomerular filtration rate < 60 mL/min (CKD-EPI formula).
- Serum phosphorus > 1.45 mmol/L (4.5 mg/dl).
You may not qualify if…
- Patients refuse to sign the informed consent form for the study.
- Non-degenerative valvular heart disease even if there is valvular calcification, such as rheumatic valvular heart disease, congenital valvular heart disease, etc.
- Valve lesions are evaluated by cardiac surgeons and have indications for surgical thoracotomy or interventional medical treatment and there are no surgical contraindications.
- Life expectancy less than 1 year. ⑤ Abnormal parathyroid function.
- Those with renal insufficiency who are planned to undergo dialysis treatment within half a year.
- Malignant tumor.
Where it is running
- Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Science — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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