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Calcium-Phosphorus Regulation Therapy on Heart Valve Disease

NCT06660524 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2024-10-28

No results posted yet for this 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.

Conditions

  • Degenerative Heart Valve Disease
  • Heart Valve Calcification
  • Chronic Kidney Disease(CKD)
  • Calcium-Phosphorus Metabolism Disorders

Interventions

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.

Sponsors & Collaborators

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06660524 on ClinicalTrials.gov