Actively Recruiting

Phase 4
Age: 50Years +
All Genders
NCT06660524

Calcium-Phosphorus Regulation Therapy on Heart Valve Disease

Led by China National Center for Cardiovascular Diseases · Updated on 2024-10-28

196

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Calcium-Phosphorus Regulation Therapy on Heart Valve Disease

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older
  • Diagnosed degenerative valvular heart disease with calcification shown by ultrasound or clinical history
  • Glomerular filtration rate below 60 mL/min (CKD-EPI formula)
  • Serum phosphorus level greater than 1.45 mmol/L (4.5 mg/dL)
Not Eligible

You will not qualify if you...

  • Refusal to sign informed consent
  • Non-degenerative valvular heart disease such as rheumatic or congenital valve disease
  • Valve lesions requiring surgical or interventional treatment without contraindications
  • Life expectancy less than one year
  • Abnormal parathyroid function
  • Planned dialysis treatment within six months
  • Presence of malignant tumor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Science

Beijing, Beijing Municipality, China, 100037

Actively Recruiting

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Research Team

Z

Zhe Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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