Clinical Study on the Influence of Calcium and Phosphorus Regulation Therapy on Valvular Heart Disease.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Science
RECRUITING
Beijing
Contact Information
Primary
Zhe Li
ada521521@126.com
00-86-010-88398866
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 196
Treatments
Experimental: Sevelamer Treatment
Sevelamer 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.
Active_comparator: Calcium Carbonate Treatment
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.
Related Therapeutic Areas
Sponsors
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov