Computed tomography aortic valve calcium scoring for the assessment of aortic stenosis progression.
Mhairi Katrina Doris, William Jenkins, Philip Robson...
https://pubmed.ncbi.nlm.nih.gov/33020228Actively Recruiting
Phase 4
Age: 50Years +
All Genders
ID06660524
Clinical Study on the Influence of Calcium and Phosphorus Regulation Therapy on Valvular Heart Disease
Led by China National Center for Cardiovascular Diseases · Updated on 2024-10-28
196
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether calcium-phosphorus regulation therapy can slow the progression of heart valve calcification in people with degenerative heart valve disease and chronic kidney disease (CKD). The study aims to compare the effects of Sevelamer and calcium carbonate over 12 months to see which treatment better reduces heart valve calcification and impacts major cardiovascular events like heart failure, cardiovascular death, and the need for valve surgery. Participants will take either Sevelamer or calcium carbonate orally according to established guidelines for managing mineral and bone disorders in CKD. The treatment lasts for 12 months, with dosing strategies based on the 2017 KDIGO Guideline and the 2019 Chinese Guideline. The study includes follow-up visits at 3, 6, 9, and 12 months to monitor blood tests and adjust treatment as needed. During the study, participants undergo echocardiography and CT scans at the start and after 12 months to assess heart valve calcification. Researchers will monitor blood phosphorus levels and kidney function regularly. The main outcome measured is the change in valve calcification score on CT scans from baseline to one year. Secondary outcomes include major cardiovascular events during the same period. The trial is randomized and open-label, with total participation lasting one year.
CONDITIONS
Brief Title
Calcium-Phosphorus Regulation Therapy on Heart Valve Disease
Who Can Participate
Age: 50Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Diagnosed degenerative valvular heart disease with calcification shown by ultrasound or clinical history
- Chronic kidney disease with glomerular filtration rate less than 60 mL/min (CKD-EPI formula)
- Serum phosphorus level greater than 1.45 mmol/L (4.5 mg/dl)
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 needing surgical or interventional treatment without contraindications
- Life expectancy less than 1 year
- Abnormal parathyroid function
- Planned dialysis treatment within 6 months
- Presence of malignant tumor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 year of treatment
Participants receive oral calcium-phosphorus regulation therapy with either Sevelamer or Calcium carbonate as per clinical guidelines.
Regular visits for monitoring throughout treatment
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
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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Published Research Related To This Trial
Prevalence and clinical implications of valvular calcification on coronary computed tomography angiography.
Michelle C Williams, Daniele Massera, Alastair J Moss...
https://pubmed.ncbi.nlm.nih.gov/333061042021 ESC/EACTS Guidelines for the management of valvular heart disease.
Alec Vahanian, Friedhelm Beyersdorf, Fabien Praz...
https://pubmed.ncbi.nlm.nih.gov/34453165A new equation to estimate glomerular filtration rate.
Andrew S Levey, Lesley A Stevens, Christopher H Schmid...
https://pubmed.ncbi.nlm.nih.gov/19414839Sevelamer Attenuates Bioprosthetic Heart Valve Calcification.
Zhen Meng, Zhe Li, Erli Zhang...
https://pubmed.ncbi.nlm.nih.gov/34660741Valvular heart disease in patients with chronic kidney disease.
Julian Hoevelmann, Felix Mahfoud, Lucas Lauder...
https://pubmed.ncbi.nlm.nih.gov/33394059Valvular heart disease and calcification in CKD: more common than appreciated.
Pablo Ureña-Torres, Luis D'Marco, Paolo Raggi...
https://pubmed.ncbi.nlm.nih.gov/31326992KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD).
Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group
https://pubmed.ncbi.nlm.nih.gov/30675420Multi-Omics Approaches to Define Calcific Aortic Valve Disease Pathogenesis.
Mark C Blaser, Simon Kraler, Thomas F Lüscher...
https://pubmed.ncbi.nlm.nih.gov/33914608Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis.
Anne B Rossebø, Terje R Pedersen, Kurt Boman...
https://pubmed.ncbi.nlm.nih.gov/18765433