Actively Recruiting
Calcium-Phosphorus Regulation Therapy on Heart Valve Disease
Led by China National Center for Cardiovascular Diseases · Updated on 2024-10-28
196
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Calcium-Phosphorus Regulation Therapy on Heart Valve Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Diagnosed degenerative valvular heart disease with calcification shown by ultrasound or clinical history
- Glomerular filtration rate below 60 mL/min (CKD-EPI formula)
- Serum phosphorus level greater than 1.45 mmol/L (4.5 mg/dL)
You will not qualify if you...
- Refusal to sign informed consent
- Non-degenerative valvular heart disease such as rheumatic or congenital valve disease
- Valve lesions requiring surgical or interventional treatment without contraindications
- Life expectancy less than one year
- Abnormal parathyroid function
- Planned dialysis treatment within six months
- Presence of malignant tumor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
Z
Zhe Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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