Calcium-Phosphorus Regulation Therapy on Heart Valve Disease

October 24, 2024 updated by: China National Center for Cardiovascular Diseases

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

196

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Science
        • Contact:
          • Jianfang Cai
        • Contact:
          • Yongjian Wu
        • Contact:
          • Zhe Li
        • Contact:
          • Haiyan Xu
        • Contact:
        • Contact:
          • Lili Liu
        • Contact:
          • Weiwei Wang
        • Contact:
          • Guannan Niu
        • Contact:
          • Xinshuang Ren
        • Contact:
          • Lili Niu
        • Contact:
          • Qingrong Liu
        • Contact:
          • Dejing Feng
        • Contact:
          • Xiangming Hu
        • Contact:
          • Cheng Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of valve calcification score on CT scan from baseline to 1 year of treatment.
Time Frame: from baseline to 1 year of treatment
The change of valve calcification score on CT scan from baseline to 1 year of treatment.
from baseline to 1 year of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major cardiovascular events
Time Frame: from baseline to 1 year of treatment
The composite endpoint of major cardiovascular events includes hospitalization or outpatient/emergency department visits due to heart failure; cardiovascular death; undergoing interventional/surgical valve surgery; and non-fatal myocardial infarction.
from baseline to 1 year of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-GSP-GG-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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