Degenerative Heart Valve Disease, Heart Valve Calcification, Chronic Kidney Disease(CKD), Calcium-Phosphorus Metabolism Disorders
Conditions
Keywords
Heart Valve Calcification, Degenerative Valve Disease, Chronic Kidney Disease, Calcium-Phosphorus Regulation, Sevelamer
Brief 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.
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.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized grouping is generated by applying the data entry platform. According to the randomization results, the experimental group is given a sevelamer prescription, and the control group is given a calcium carbonate prescription.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of valve calcification score on CT scan from baseline to 1 year of treatment. | from baseline to 1 year of treatment | The change of valve calcification score on CT scan from baseline to 1 year of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| major cardiovascular events | from baseline to 1 year of treatment | The composite endpoint of major cardiovascular events includes hospitalization or outpatient/emergency department visits due to heart failure; cardiovascular death; undergoing interventional/surgical valve surgery; and non-fatal myocardial infarction. |
Countries
China
Contacts
Primary ContactZhe Li
Outcome results
None listed