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NCT Number: NCT06660524

Calcium-Phosphorus Regulation Therapy on Heart Valve 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.

Recruiting

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Key information

Conditions

Degenerative Heart Valve Disease Calcium-Phosphorus Metabolism Disorders Chronic Disease Chronic Kidney Disease(CKD) Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Valve Calcification Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Cheng Yang

SUB_INVESTIGATOR

Dejing Feng

SUB_INVESTIGATOR

Guannan Niu

SUB_INVESTIGATOR

Haiyan Xu

SUB_INVESTIGATOR

Jianfang Cai

SUB_INVESTIGATOR

Lili Liu

SUB_INVESTIGATOR

Lili Niu

SUB_INVESTIGATOR

Qingrong Liu

SUB_INVESTIGATOR

Weiwei Wang

SUB_INVESTIGATOR

Xiangming Hu

SUB_INVESTIGATOR

Xinshuang Ren

SUB_INVESTIGATOR

Yongjian Wu

SUB_INVESTIGATOR

Zhe Li

CONTACT

[email protected]

00-86-010-88398866

Zhe Li

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sevelamer

Drug

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.

Calcium Carbonate

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhe Li

CONTACT

[email protected]

00-86-010-88398866

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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