Calcium-Phosphorus Regulation Therapy on Heart Valve Disease

NCT06660524 · tracked via the Priya Life Science China tracker

Sponsor

China National Center for Cardiovascular Diseases

Phase

Phase 4

Started

2024-03-01

Last updated

2024-10-28

Condition(s) studied

Degenerative Heart Valve DiseaseHeart Valve CalcificationChronic Kidney Disease(CKD)Calcium-Phosphorus Metabolism Disorders

Investigational drug(s) / intervention(s)

SevelamerCalcium carbonate

Sevelamer: 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.

Calcium 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.

Study 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

Sex

ALL

Min age

50 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Science	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06660524 on ClinicalTrials.gov ↗ ← All trials in China