[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647814":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":32,"responsibleParty":43,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":32,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":79,"whyStopped":32,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":32},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vericiguat","ACTIVE_COMPARATOR","Vericiguat orally once daily.",[13],"Drug: Vericiguat (BAY1021189)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Matching placebo tablets orally once daily",[19],"Drug: Placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Vericiguat (BAY1021189)","Vericiguat 2.5 mg orally once daily, titrated every 2 weeks (2.5 mg → 5 mg → 10 mg) to a target maintenance dose of 10 mg once daily. Total treatment duration: 24 months",[9],[27,28],"MK-1242","BAY 1021189",{"type":22,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"Matching placebo tablets orally once daily, with a dose-titration schedule synchronized to the vericiguat arm to maintain blinding. Placebo tablets are identical to vericiguat tablets (2.5 mg, 5 mg, and 10 mg dose strengths) in size, shape, color, and texture. The same SBP-based dose-adjustment rules are applied. Total treatment duration: 24 months.",[15],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Fangyang Huang, MD","CONTACT","+86-18980607283","fyhuang1989@wchscu.cn",{"name":40,"role":36,"phone":41,"phoneExt":32,"email":42},"Yan Wang, MD","+86-15319969201","gloriawang_98@163.com",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Mao Chen","Director of Department of Cardiology",[48],{"name":49,"class":50},"Bayer","INDUSTRY","100647814","phase-2-vericiguat-for-the-inhibition-of-calcific-aortic-valve-stenosis-progression-100647814",false,"NCT07715279","Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression","Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (VERIFICATION Study)","VERIFICATION","Inclusion Criteria:\n\n1. The participant agrees to enter this clinical trial and consents to long-term follow-up;\n2. 35 ≤ age \\\u003C 80 years;\n3. Echocardiographically confirmed mild-to-moderate (peak aortic jet velocity ≥ 2.5 m\u002Fs and \\\u003C 4.0 m\u002Fs, aortic valve area \\> 1.0 cm², and mean aortic valve pressure gradient \\\u003C 40 mmHg) non-rheumatic aortic valve stenosis;\n4. Baseline aortic valve calcium score (Agatston score) ≥ 200 AU as measured by cardiac CT;\n5. Male participants, or female participants who are not of childbearing potential, or female participants who commit to avoiding pregnancy through 4 weeks after the end of the trial.\n\nExclusion Criteria:\n\n1. Severe aortic stenosis (AS peak velocity ≥ 4.0 m\u002Fs, or mean transvalvular aortic pressure gradient ≥ 40 mmHg, or aortic valve area ≤ 1.0 cm², or indexed effective aortic valve area \\\u003C 0.6 cm²\u002Fm²), or very mild stenosis (AS peak velocity \\\u003C 2.5 m\u002Fs), or a planned aortic valvuloplasty\u002Freplacement procedure;\n2. Concomitant severe mitral or tricuspid valve disease (moderate or greater mitral or tricuspid regurgitation, or prior mitral or tricuspid valve repair\u002Fvalvuloplasty\u002Freplacement);\n3. Concomitant moderate or greater aortic regurgitation;\n4. Use, within 1 month prior to the screening visit, of medications affecting the NO-sGC-cGMP pathway (e.g., sildenafil, nitrates, etc.), or known hypersensitivity to vericiguat or its components;\n5. Left ventricular ejection fraction (LVEF) \\\u003C 50%, or NYHA class III-IV (see Appendix 4 for NYHA classification criteria);\n6. Presence of a malignancy (except those with an expected cure) or other serious non-cardiac disease with a life expectancy of less than 3 years;\n7. Rheumatic valvular heart disease;\n8. Systolic blood pressure (SBP) \\\u003C 120 mmHg, or a history of symptomatic hypotension, or a history of hemodynamic instability or hypovolemia within the 4 weeks prior to screening;\n9. Presence of hypertrophic obstructive cardiomyopathy (outflow tract obstruction defined as a peak left ventricular outflow tract pressure gradient ≥ 30 mmHg at rest or after provocative testing);\n10. Infective endocarditis or complex congenital heart disease;\n11. Estimated glomerular filtration rate \\\u003C 15 mL\u002Fmin\u002F1.73 m², or on dialysis;\n12. Severe pulmonary disease requiring continuous home oxygen therapy;\n13. Interstitial lung disease;\n14. Concomitant disorder of calcium-phosphate metabolism;\n15. Current use of warfarin;\n16. ALT and AST ≥ 3 times the upper limit of normal, or severe hepatic insufficiency (e.g., cirrhosis, chronic active liver disease);\n17. Inability to undergo contrast-enhanced CT, or contrast media allergy;\n18. Concomitant acute myocarditis, cardiac amyloidosis, cardiac sarcoidosis, or stress (takotsubo) cardiomyopathy;\n19. Presence of acute coronary syndrome (including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction) within 60 days prior to randomization, or an indication for coronary revascularization (percutaneous intervention\u002Fbypass surgery); or a need for coronary revascularization identified at the time of randomization;\n20. History of cerebrovascular accident (including TIA or stroke) within 60 days prior to randomization;\n21. Psychiatric disorder or legal incapacity precluding the ability to provide informed consent;\n22. Any medical condition, circumstance, or history that, in the investigator's judgment, would compromise the participant's ability to participate in or complete the study.","ALL","35 Years","80 Years",{"count":63,"type":64},238,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","Calcific aortic valve stenosis (CAVS) is a condition in which the aortic valve progressively narrows and stiffens due to calcium deposition, eventually impairing blood flow from the heart to the body. No drug therapy has been proven to slow CAVS progression. Individuals with mild-to-moderate CAVS are managed with periodic monitoring until the stenosis becomes severe, at which point surgical or transcatheter valve replacement is the only treatment option. The goal of this clinical trial is to determine whether vericiguat, an oral soluble guanylate cyclase (sGC) stimulator, can slow the progression of mild-to-moderate CAVS.\n\nThe primary questions this study aims to answer are:\n\nDoes vericiguat slow the progression of aortic valve calcium accumulation, as measured by the change in aortic valve calcium score from baseline to 24 months, compared to placebo?\n\nThe study will compare vericiguat against a placebo (an inactive pill that is identical in appearance but contains no active drug). Both participants and the research team will not know which treatment each participant is receiving throughout the study.\n\nParticipants will:\n\nTake vericiguat or placebo orally once daily for 24 months; Begin treatment at 2.5 mg\u002Fday and undergo a stepwise dose increase every two weeks to a target dose of 10 mg\u002Fday, provided the drug is tolerated; Attend approximately 8 scheduled study visits over two years, during which they will undergo cardiac imaging examinations (transthoracic echocardiography and non-contrast cardiac CT), blood sample collection, physical assessment, and completion of standardized questionnaires on quality of life and heart failure symptoms; Undergo cardiac magnetic resonance imaging (MRI) at the beginning and end of the study, if there are no contraindications.\n\nApproximately 238 participants will be enrolled across roughly 19 hospitals in China.",[70,71,72],"Calcific Aortic Valve Disease","AORTIC VALVE DISEASES","Aortic Valve Stenosis",[9,74,75,76,77,78],"BAY1021189","Soluble Guanylyl Cyclase","sGC stimulator","sGC activator","Cyclic GMP","NOT_YET_RECRUITING","2026-07-18",{"date":82,"type":83},"2026-07-21","ACTUAL",{"date":85,"type":64},"2026-08-20",{"date":87,"type":64},"2029-11-30",{"name":5,"class":6}]