Degenerative Heart Valve DiseasePhase 4NCT06660524
Calcium-Phosphorus Regulation Therapy on Heart Valve Disease
A Phase 4 study testing Sevelamer and Calcium carbonate in people with Degenerative Heart Valve Disease and Heart Valve Calcification, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Degenerative Heart Valve Disease, Heart Valve Calcification, Chronic Kidney Disease(CKD)
- What is being tested?
- Sevelamer and Calcium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100037
Zhe Li, 00-86-010-88398866, ada521521@126.com
Zhe Li
About this study
Official title: 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.
Read more
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
- Being tested
- Sevelamer, Calcium carbonate
- Keywords
- Heart Valve Calcification, Degenerative Valve Disease, Chronic Kidney Disease, Calcium-Phosphorus Regulation, Sevelamer
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevelamerDrug
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 carbonateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to 1 year of treatment
Secondary outcomes (1)
major cardiovascular events
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.
Measured: from baseline to 1 year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Mar 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Degenerative Heart Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660524
- Sponsor's protocol ID
- 2023-GSP-GG-38
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Doris MK, Jenkins W, Robson P, Pawade T, Andrews JP, Bing R, Cartlidge T, Shah A, Pickering A, Williams MC, Fayad ZA, White A, van Beek EJ, Newby DE, Dweck MR. Computed tomography aortic valve calcium scoring for the assessment of aortic stenosis progression. Heart. 2020 Dec;106(24):1906-1913. doi: 10.1136/heartjnl-2020-317125. Epub 2020 Oct 5.
PubMed 33020228Williams MC, Massera D, Moss AJ, Bing R, Bularga A, Adamson PD, Hunter A, Alam S, Shah ASV, Pawade T, Roditi G, van Beek EJR, Nicol ED, Newby DE, Dweck MR. Prevalence and clinical implications of valvular calcification on coronary computed tomography angiography. Eur Heart J Cardiovasc Imaging. 2021 Feb 22;22(3):262-270. doi: 10.1093/ehjci/jeaa263.
PubMed 33306104Vahanian 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.
PubMed 34453165Levey 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.
PubMed 19414839Meng 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.
PubMed 34660741Hoevelmann 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.
PubMed 33394059Urena-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.
PubMed 31326992Kidney 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.
PubMed 30675420Blaser 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.
PubMed 33914608Rossebo 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.
PubMed 18765433Moura 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.
PubMed 17276178Chan KL, Teo K, Dumesnil JG, Ni A, Tam J; ASTRONOMER Investigators. Effect of Lipid lowering with rosuvastatin on progression of aortic stenosis: results of the aortic stenosis progression observation: measuring effects of rosuvastatin (ASTRONOMER) trial. Circulation. 2010 Jan 19;121(2):306-14. doi: 10.1161/CIRCULATIONAHA.109.900027. Epub 2010 Jan 4.
PubMed 20048204Yadgir S, Johnson CO, Aboyans V, Adebayo OM, Adedoyin RA, Afarideh M, Alahdab F, Alashi A, Alipour V, Arabloo J, Azari S, Barthelemy CM, Benziger CP, Berman AE, Bijani A, Carrero JJ, Carvalho F, Daryani A, Duraes AR, Esteghamati A, Farid TA, Farzadfar F, Fernandes E, Filip I, Gad MM, Hamidi S, Hay SI, Ilesanmi OS, Naghibi Irvani SS, Jurisson M, Kasaeian A, Kengne AP, Khan AR, Kisa A, Kisa S, Kolte D, Manafi N, Manafi A, Mensah GA, Mirrakhimov EM, Mohammad Y, Mokdad AH, Negoi RI, Thi Nguyen HL, Nguyen TH, Nixon MR, Otto CM, Patel S, Pilgrim T, Radfar A, Rawaf DL, Rawaf S, Rawasia WF, Rezapour A, Roever L, Saad AM, Saadatagah S, Senthilkumaran S, Sliwa K, Tesfay BE, Tran BX, Ullah I, Vaduganathan M, Vasankari TJ, Wolfe CDA, Yonemoto N, Roth GA; Global Burden of Disease Study 2017 Nonrheumatic Valve Disease Collaborators. Global, Regional, and National Burden of Calcific Aortic Valve and Degenerative Mitral Valve Diseases, 1990-2017. Circulation. 2020 May 26;141(21):1670-1680. doi: 10.1161/CIRCULATIONAHA.119.043391. Epub 2020 Mar 29.
PubMed 32223336
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Influence of Calcium and Phosphorus Regulation Therapy on Valvular Heart Disease.
- ClinicalTrials.gov ID
- NCT06660524
- Acronym / sponsor ID
- 2023-GSP-GG-38
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sevelamer Treatment | Experimental | Drug: SevelamerSevelamer 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 | Active comparator | Drug: Calcium carbonateCalcium 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 50 years old.
Key exclusion criteria (6 listed)
- Patients refuse to sign the informed consent form for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevelamerSevelamer 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. | Drug | Sevelamer Treatment |
| Calcium carbonateCalcium 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 Treatment |
Primary outcome
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.
1 secondary outcome
major cardiovascular events
Time frame: from baseline to 1 year of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Results publication: PubMed 33020228Doris MK, Jenkins W, Robson P, Pawade T, Andrews JP, Bing R, Cartlidge T, Shah A, Pickering A, Williams MC, Fayad ZA, White A, van Beek EJ, Newby DE, Dweck MR. Computed tomography aortic valve calcium scoring for the assessment of aortic stenosis progression. Heart. 2020 Dec;106(24):1906-1913. doi: 10.1136/heartjnl-2020-317125. Epub 2020 Oct 5.
- Results publication: PubMed 33306104Williams MC, Massera D, Moss AJ, Bing R, Bularga A, Adamson PD, Hunter A, Alam S, Shah ASV, Pawade T, Roditi G, van Beek EJR, Nicol ED, Newby DE, Dweck MR. Prevalence and clinical implications of valvular calcification on coronary computed tomography angiography. Eur Heart J Cardiovasc Imaging. 2021 Feb 22;22(3):262-270. doi: 10.1093/ehjci/jeaa263.
- Results publication: PubMed 34453165Vahanian 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.
- Results publication: PubMed 19414839Levey 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.
- Results publication: PubMed 34660741Meng 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.
- Results publication: PubMed 33394059Hoevelmann 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.
- Results publication: PubMed 31326992Urena-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.
- Results publication: PubMed 30675420Kidney 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.
- Results publication: PubMed 33914608Blaser 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.
- Results publication: PubMed 18765433Rossebo 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.
- Results publication: PubMed 17276178Moura 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.
- Results publication: PubMed 20048204Chan KL, Teo K, Dumesnil JG, Ni A, Tam J; ASTRONOMER Investigators. Effect of Lipid lowering with rosuvastatin on progression of aortic stenosis: results of the aortic stenosis progression observation: measuring effects of rosuvastatin (ASTRONOMER) trial. Circulation. 2010 Jan 19;121(2):306-14. doi: 10.1161/CIRCULATIONAHA.109.900027. Epub 2010 Jan 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevelamer and Calcium carbonate in people with Degenerative Heart Valve Disease and Heart Valve Calcification, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhe Li (00-86-010-88398866, ada521521@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06660524, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.