Trials / Recruiting
RecruitingNCT06660524
Calcium-Phosphorus Regulation Therapy on Heart Valve Disease
Clinical Study on the Influence of Calcium and Phosphorus Regulation Therapy on Valvular Heart Disease.
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 196 (estimated)
- Sponsor
- China National Center for Cardiovascular Diseases · Other Government
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Degenerative Heart Valve Disease
- Heart Valve Calcification
- Chronic Kidney Disease(CKD)
- Calcium-Phosphorus Metabolism Disorders
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
| DRUG | 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. |
Timeline
- Start date
- 2024-03-01
- Primary completion
- 2025-06-01
- Completion
- 2025-12-01
- First posted
- 2024-10-28
- Last updated
- 2024-10-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06660524. Inclusion in this directory is not an endorsement.