Calcium-phosphorus therapy for heart valve disease
Clinical Study on the Influence of Calcium and Phosphorus Regulation Therapy on Valvular Heart Disease.
This study is testing if a new treatment with Sevelamer can help slow down heart valve problems in people with heart valve disease and chronic kidney disease compared to a standard treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06660524 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether calcium-phosphorus regulation therapy can slow the progression of heart valve calcification in patients with degenerative heart valve disease and chronic kidney disease (CKD). Participants will be randomly assigned to receive either Sevelamer or calcium carbonate daily for 12 months. The study will assess the effectiveness of Sevelamer in reducing heart valve calcification compared to calcium carbonate, as well as its impact on major cardiovascular events. Participants will undergo echocardiography and CT scans at the beginning and end of the study, along with regular follow-up visits to monitor their health.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with degenerative valvular heart disease and chronic kidney disease.
Not a fit: Patients with non-degenerative valvular heart disease or those who are not eligible due to severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly slow the progression of heart valve calcification, improving patient outcomes and reducing the need for surgical interventions.
How similar studies have performed: Other studies have explored calcium-phosphorus regulation in related conditions, but this specific approach is novel in the context of heart valve disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Science — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhe Li
- Email: ada521521@126.com
- Phone: 00-86-010-88398866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.