Calcium-Phosphorus Regulation Therapy on Heart Valve Disease

NCT06660524 | Recruiting Phase 4

• 1 other identifier: 2023-GSP-GG-38
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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

Degenerative Heart Valve Disease; Heart Valve Calcification; Chronic Kidney Disease(CKD); Calcium-Phosphorus Metabolism Disorders

Keywords

Heart Valve Calcification; Degenerative Valve Disease; Chronic Kidney Disease; Calcium-Phosphorus Regulation; Sevelamer

Outcome Measures

Primary Outcomes (1)

• The change of valve calcification score on CT scan 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 Outcomes (1)

• major cardiovascular events

  from baseline to 1 year of treatment

Study Arms (2)

Sevelamer Treatment

EXPERIMENTAL

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

Calcium Carbonate Treatment

ACTIVE COMPARATOR

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

Interventions

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.

Sevelamer Treatment

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.

Calcium Carbonate Treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (13)

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  PMID: 33020228 BACKGROUND

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  PMID: 33306104 BACKGROUND

• Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.

  PMID: 34453165 BACKGROUND

• Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.

  PMID: 19414839 BACKGROUND

• Meng Z, Li Z, Zhang E, Zhang L, Liu Q, Wu Y. Sevelamer Attenuates Bioprosthetic Heart Valve Calcification. Front Cardiovasc Med. 2021 Sep 29;8:740038. doi: 10.3389/fcvm.2021.740038. eCollection 2021.

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• Hoevelmann J, Mahfoud F, Lauder L, Scheller B, Bohm M, Ewen S. Valvular heart disease in patients with chronic kidney disease. Herz. 2021 Jun;46(3):228-233. doi: 10.1007/s00059-020-05011-0. Epub 2021 Jan 4.

  PMID: 33394059 BACKGROUND

• Urena-Torres P, D'Marco L, Raggi P, Garcia-Moll X, Brandenburg V, Mazzaferro S, Lieber A, Guirado L, Bover J. Valvular heart disease and calcification in CKD: more common than appreciated. Nephrol Dial Transplant. 2020 Dec 4;35(12):2046-2053. doi: 10.1093/ndt/gfz133.

  PMID: 31326992 BACKGROUND

• Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl (2011). 2017 Jul;7(1):1-59. doi: 10.1016/j.kisu.2017.04.001. Epub 2017 Jun 21. No abstract available.

  PMID: 30675420 BACKGROUND

• Blaser MC, Kraler S, Luscher TF, Aikawa E. Multi-Omics Approaches to Define Calcific Aortic Valve Disease Pathogenesis. Circ Res. 2021 Apr 30;128(9):1371-1397. doi: 10.1161/CIRCRESAHA.120.317979. Epub 2021 Apr 29.

  PMID: 33914608 BACKGROUND

• Rossebo AB, Pedersen TR, Boman K, Brudi P, Chambers JB, Egstrup K, Gerdts E, Gohlke-Barwolf C, Holme I, Kesaniemi YA, Malbecq W, Nienaber CA, Ray S, Skjaerpe T, Wachtell K, Willenheimer R; SEAS Investigators. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med. 2008 Sep 25;359(13):1343-56. doi: 10.1056/NEJMoa0804602. Epub 2008 Sep 2.

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• Moura LM, Ramos SF, Zamorano JL, Barros IM, Azevedo LF, Rocha-Goncalves F, Rajamannan NM. Rosuvastatin affecting aortic valve endothelium to slow the progression of aortic stenosis. J Am Coll Cardiol. 2007 Feb 6;49(5):554-61. doi: 10.1016/j.jacc.2006.07.072. Epub 2007 Jan 22.

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  PMID: 32223336 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Sevelamer; Calcium Carbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Central Study Contacts

Zhe Li

CONTACT

00-86-010-88398866; ada521521@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized grouping is generated by applying the data entry platform. According to the randomization results, the experimental group is given a sevelamer prescription, and the control group is given a calcium carbonate prescription.

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

CN (1)