[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624154":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":46,"responsibleParty":82,"collaborators":85,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":50,"enrollmentInfo":98,"targetDuration":50,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":48,"whyStopped":50,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"University Medical Centre Ljubljana","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Vericiguat + GDMT","EXPERIMENTAL","Participants will receive vericiguat added to guideline-directed medical therapy (GDMT) for heart failure. Vericiguat will be initiated at 2.5 mg once daily and up-titrated in approximately 2-week intervals to 5 mg and then a target dose of 10 mg once daily, as tolerated, over the 12-month randomized phase.",[13,14],"Drug: Vericiguat","Drug: Guideline Directed Medical Therapy for Heart Failure (GDMT)",{"label":16,"type":17,"description":18,"interventionNames":19},"GDMT","ACTIVE_COMPARATOR","Participants will continue to receive guideline-directed medical therapy (GDMT) for heart failure without vericiguat during the 12-month randomized phase (vericiguat offered during exploratory extension).",[14],[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Vericiguat","Oral soluble guanylate cyclase stimulator administered once daily, initiated at 2.5 mg and up-titrated in approximately 2-week intervals to 5 mg and then 10 mg as tolerated, in addition to guideline-directed medical therapy for heart failure.",[9],[27,28],"Verquvo","MK-1242",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Guideline Directed Medical Therapy for Heart Failure (GDMT)","Standard combination heart failure therapy according to current guidelines (ARNI, beta-blocker, MRA, and SGLT2 inhibitor as tolerated).",[16,9],[16],[35],{"name":36,"affiliation":37,"role":38},"Gregor Poglajen, MD, PhD","Advanced Heart Failure and Transplantation Center, Department of Cardiology, University Medical Centre Ljubljana, Ljubljana, Slovenia","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Tine Bajec, MD","CONTACT","051727249","+386","tine.bajec@kclj.si",[47],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Ljubljana",null,"1000","Slovenia","SI",{"type":55,"coordinates":56},"Point",[57,58],14.50513,46.05108,{"lat":58,"lon":57},[61,62,63,65,66,68,70,72,74,76,78,80],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},{"name":50,"role":42,"phone":50,"phoneExt":50,"email":45},{"name":41,"role":64,"phone":50,"phoneExt":50,"email":50},"SUB_INVESTIGATOR",{"name":36,"role":38,"phone":50,"phoneExt":50,"email":50},{"name":67,"role":64,"phone":50,"phoneExt":50,"email":50},"Gregor Zemljič, MD, PhD",{"name":69,"role":64,"phone":50,"phoneExt":50,"email":50},"Andraž Cerar, MD, PhD",{"name":71,"role":64,"phone":50,"phoneExt":50,"email":50},"Miran Šebeštjen, MD, PhD",{"name":73,"role":64,"phone":50,"phoneExt":50,"email":50},"Neža Žorž, MD",{"name":75,"role":64,"phone":50,"phoneExt":50,"email":50},"Sabina Frljak, MD, PhD",{"name":77,"role":64,"phone":50,"phoneExt":50,"email":50},"Renata Okrajšek, MD, PhD",{"name":79,"role":64,"phone":50,"phoneExt":50,"email":50},"Sabina Ugovšek, MD",{"name":81,"role":64,"phone":50,"phoneExt":50,"email":50},"Petra Girandon Sušanj, MD",{"type":38,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Gregor Poglajen","Associate Professor",[86],{"name":87,"class":6},"Slovenian Research Agency","100624154","phase-4-vericiguat-and-reverse-remodeling-indices-in-heart-failure-100624154",false,"NCT07405944","Vericiguat and Reverse Remodeling Indices in Heart Failure","Vericiguat's Effects on Reverse Remodeling Indices: Pathophysiologic Approach to Treatment of Heart Failure With Reduced Ejection Fraction","VERI-PATH","Inclusion Criteria:\n\n* Written informed consent from an adult patient (≥ 18 years old) to participate in the clinical study,\n* Stable HFrEF defined as no heart failure worsening in the 6 months before randomization that required hospitalization or outpatient diuretic treatment,\n* Confirmed diagnosis of chronic heart failure with reduced ejection fraction (LVEF ≤ 40%, confirmed by echocardiography) within 12 months before randomization,\n* Stable GDMT for HFrEF for at least 3 months prior to randomisation.\n\nExclusion Criteria:\n\n* Systolic blood pressure \\\u003C 100 mmHg or symptomatic hypotension,\n* Current or planned use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type V inhibitors,\n* Known allergy\u002Fhypersensitivity to soluble guanylate cyclase stimulators,\n* Awaiting heart transplantation or dependence on continuous inotropic therapy\n* Cardiac amyloidosis, sarcoidosis, myocarditis, stress cardiomyopathy, or tachycardic cardiomyopathy,\n* Acute coronary syndrome, coronary artery bypass grafting, or percutaneous coronary intervention in the past three months before randomisation,\n* Long-term mechanical circulatory support of the left ventricle,\n* Active infection,\n* Chronic kidney disease stage 4 or 5, and\n* Advanced liver failure classified as Child-Pugh B or C.","ALL","18 Years",{"count":99,"type":100},60,"ESTIMATED","INTERVENTIONAL",[103],"PHASE4","The goal of this clinical trial is to investigate how vericiguat benefits adults with stable heart failure with reduced ejection fraction (HFrEF) who are already receiving guideline-directed medical therapy.\n\nThe main questions are:\n\n* Does vericiguat improve right ventricular systolic function, measured by tricuspid annular plane systolic excursion (TAPSE)?\n* Does vericiguat favourably influence myocardial remodeling, fibrosis, angiogenesis, inflammation, metabolism, renal function, and hematologic balance?\n* Do genetic and oxidative stress profiles modify treatment response? Researchers will compare a group receiving vericiguat plus usual care with a group receiving usual care alone to assess structural, functional, and biomarker changes over 12 months.\n\nParticipants will:\n\n* Have blood drawn at baseline and follow-up visits for biomarker, metabolomic, genetic, transcriptomic, and hematologic analyses, including platelet function testing\n* Perform oral glucose tolerance tests (OGTT) to assess insulin resistance\n* Undergo echocardiography, cardiac magnetic resonance imaging, and cardiac scintigraphy to evaluate heart structure, function, and perfusion\n* Attend follow-up visits at 1, 3, 6, and 12 months Open-label extension: After the 12-month randomized phase, participants originally assigned to usual care will be offered open-label vericiguat and followed for an additional 12 months. This exploratory extension will reassess study outcomes to evaluate the consistency and magnitude of response to vericiguat in the prior control cohort.",[106,107],"Heart Failure With Reduced Ejection Fraction (HFrEF)","Chronic Heart Failure",[23,109,110,111,112,113,114,115,116,117,118,119],"Soluble Guanylate Cyclase","Cyclic GMP","Reverse Remodeling","Cardiac Magnetic Resonance Imaging","Myocardial Perfusion Imaging","Fibrosis","Inflammation","Angiogenesis","Oxidative Stress","Immunomodulation","Insulin Resistance","2026-02-08",{"date":122,"type":123},"2026-02-12","ACTUAL",{"date":125,"type":123},"2025-11-01",{"date":127,"type":100},"2027-12-31",{"name":5,"class":6},1]