[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615662":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":35,"responsibleParty":144,"collaborators":148,"id":152,"slug":153,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":154,"sex":159,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":12,"studyType":165,"phases":166,"briefSummary":168,"conditions":169,"keywords":175,"overallStatus":185,"whyStopped":12,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"fullName":5,"class":6},"IRCCS Policlinico S. Donato","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual care","NO_INTERVENTION","Participants in the usual care arm will receive sequential introduction and adjustment of guideline-directed medical therapy (GDMT) according to the treating cardiologist or general physician's clinical judgment, following routine practice. Follow-up will occur at weeks 6, 12, 24, 36, and 52 after randomization, with clinical visits and intermediate phone contacts as per standard care.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"High-intensity care","EXPERIMENTAL","Participants assigned to the high-intensity arm will begin rapid initiation and optimization of guideline-directed medical therapy (GDMT) according to the STRONG-HF protocol. During hospitalization, eligible therapies (beta-blockers (BB), Angiotensin converting enzyme inhibitor(ACEi) \u002FAngiotensin II receptor blocker (ARB)\u002FAngiotensin Receptor-Neprilysin Inhibitors(ARNI), Mineralocorticoid Receptor Antagonists (MRA), and Sodium-Glucose Co-Transporter inhibitor 2 (SGLT2i) for HFrEF\u002FHFmrEF; MRA and SGLT2i for HFpEF will be prescribed at least at half of the recommended target dose. Further titration toward full optimal doses will be performed within the first 6 weeks if clinically appropriate. Participants will undergo clinical assessments at weeks 2, 4, 6, 12, 24, 36, and 52, with safety monitoring including vital signs, physical examination, and laboratory evaluation (NT-proBNP, electrolytes, kidney function). Additional visits may occur after any up-titration if needed for safety.",[18],"Drug: Guideline-Directed Medical Therapy (GDMT)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","Guideline-Directed Medical Therapy (GDMT)","Guideline-directed medical therapy (GDMT) including beta-blockers, ACE inhibitors or ARBs or ARNIs, mineralocorticoid receptor antagonists, and SGLT2 inhibitors, all approved and commercially available, used according to current ESC guidelines.\n\nParticipants in the high-intensity care arm are assigned to a strategy of rapid initiation and optimization of GDMT based on the STRONG-HF protocol. Eligible therapies (beta-blockers, ACEi\u002FARB\u002FARNI, mineralocorticoid receptor antagonists, and SGLT2 inhibitors for HFrEF\u002FHFmrEF; MRA and SGLT2 inhibitors for HFpEF) are started during hospitalization at least at half of the recommended target dose, followed by frequent clinical assessments and dose titration, when clinically appropriate, within 6 weeks. Safety monitoring includes clinical examination, vital signs, laboratory tests (NT-proBNP, electrolytes, kidney function), and additional visits after each titration if needed.",[14],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Massimo Piepoli, MD","CONTACT","0252774966","MASSIMO.PIEPOLI@GRUPPOSANDONATO.IT",{"name":32,"role":28,"phone":33,"phoneExt":12,"email":34},"Giovanna Landi, PharmD","0252774885","GIOVANNA.LANDI@GRUPPOSANDONATO.IT",[36,54,62,70,78,86,94,102,107,115,123,131,139],{"facility":37,"status":12,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"IRCCS Policlinico San Donato","San Donato Milanese","MILANO","20097","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],9.26838,45.41047,{"lat":47,"lon":46},[50,52],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":51},"massimo.piepoli@grupposandonato.it",{"name":32,"role":28,"phone":33,"phoneExt":12,"email":53},"giovanna.landi@grupposandonato.it",{"facility":55,"status":12,"city":56,"state":12,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":12},"Azienda Ospedaliero Universitaria Delle Marche","Ancona",{"type":44,"coordinates":58},[59,60],13.5103,43.60717,{"lat":60,"lon":59},{"facility":63,"status":12,"city":64,"state":12,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":65,"geoPoint":69,"contacts":12},"Azienda Sanitaria Locale Bari","Bari",{"type":44,"coordinates":66},[67,68],16.86982,41.12066,{"lat":68,"lon":67},{"facility":71,"status":12,"city":72,"state":12,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":12},"Azienda USL Toscana Nord Ovest - Cecina","Cecina",{"type":44,"coordinates":74},[75,76],10.51729,43.30621,{"lat":76,"lon":75},{"facility":79,"status":12,"city":80,"state":12,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":81,"geoPoint":85,"contacts":12},"Ospedale Universitario di Ferrara","Ferrara",{"type":44,"coordinates":82},[83,84],11.62057,44.83804,{"lat":84,"lon":83},{"facility":87,"status":12,"city":88,"state":12,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":89,"geoPoint":93,"contacts":12},"Azienda USL Toscana Centro","Florence",{"type":44,"coordinates":90},[91,92],11.24626,43.77925,{"lat":92,"lon":91},{"facility":95,"status":12,"city":96,"state":12,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":97,"geoPoint":101,"contacts":12},"Centro Cardiologico Monzino","Milan",{"type":44,"coordinates":98},[99,100],12.59836,42.78235,{"lat":100,"lon":99},{"facility":103,"status":12,"city":96,"state":12,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":104,"geoPoint":106,"contacts":12},"Istituto Auxologico Italiano",{"type":44,"coordinates":105},[99,100],{"lat":100,"lon":99},{"facility":108,"status":12,"city":109,"state":12,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":110,"geoPoint":114,"contacts":12},"Fondazione Toscana Gabriele Monasterio","Pisa",{"type":44,"coordinates":111},[112,113],10.4036,43.70853,{"lat":113,"lon":112},{"facility":116,"status":12,"city":117,"state":12,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":118,"geoPoint":122,"contacts":12},"Ospedale S. Maria delle Croci","Ravenna",{"type":44,"coordinates":119},[120,121],12.20121,44.41344,{"lat":121,"lon":120},{"facility":124,"status":12,"city":125,"state":12,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":126,"geoPoint":130,"contacts":12},"Azienda USL IRCCS Di Reggio Emilia","Reggio Emilia",{"type":44,"coordinates":127},[128,129],10.63125,44.69825,{"lat":129,"lon":128},{"facility":132,"status":12,"city":133,"state":12,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":134,"geoPoint":138,"contacts":12},"Fondazione Policlinico Universitario Campus Bio-medico","Roma",{"type":44,"coordinates":135},[136,137],11.10642,44.99364,{"lat":137,"lon":136},{"facility":140,"status":12,"city":133,"state":12,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":141,"geoPoint":143,"contacts":12},"Ospedale San Camillo Forlanini",{"type":44,"coordinates":142},[136,137],{"lat":137,"lon":136},{"type":145,"investigatorFullName":146,"investigatorTitle":147,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Massimo Piepoli","Professor",[149],{"name":150,"class":151},"Agenzia Italiana del Farmaco","OTHER_GOV","100615662","phase-4-pharmacological-optimization-in-prevention-in-heart-failure-a-sex-gap-100615662",false,"NCT07295522","Pharmacological Optimization in Prevention in Heart Failure: A Sex-gap?","PopS-HF","Inclusion Criteria:\n\n1. Female patients \\>18 \\\u003C85 years.\n2. Hospital admission within the 72 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and\u002For symptoms of heart failure such as edema and\u002For positive rales on auscultation.\n3. All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.\n4. All measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mEq\u002FL (mmol\u002FL).\n5. Biomarker criteria for persistent congestion:\n\n   5.1. At Screening, NT-proBNP \\>1,800 pg\u002FmL (2,350 pg\u002FmL in case of atrial fibrillation) 5.2. At the time of Randomization (1-2 days prior to discharge), NT-proBNP \\>1,000 pg\u002FmL (1,300 pg\u002FmL in case of Atrial Fibrillation) to ensure the persistence of congestion and the acuity of the index episode).\n6. At 1 week prior to admission, at Screening, and at Visit 2 6.1. If EF\\\u003C50% (ie HFrEF or HFmrEF) either \\\u003C½ the optimal dose of ACEi\u002FARB\u002FARNi and MRA and BB or no SGLT2i (see Table) must have been prescribed 6.2. If EF\\>50% (ie HFpEF): \\\u003C½ the optimal dose of MRA (see Table) or no SGLT2i.\n7. Written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Male patients\n2. Age \\\u003C 18 or \\> 85 years.\n3. Mechanical ventilation (not including CPAP\u002FBIPAP) in the 24 hours prior to Screening.\n4. Significant pulmonary disease contributing substantially to the patients' dyspnoea such as FEV1 \\\u003C1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism.\n5. Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to Screening or during the index event.\n6. Index Event (admission for Acute Heart Failure) triggered primarily by a correctable aetiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation\u002Fflutter with sustained ventricular response \\>130 beats per minute, or bradycardia with sustained ventricular arrhythmia \\\u003C45 beats per minute), infection, severe anaemia, acute coronary syndrome, pulmonary embolism, exacerbation of Chronic Obstructive Pulmonary Disease (COPD), planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion.\n7. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.\n8. History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device.\n9. Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.\n10. Presence at Screening of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any hemodynamically significant obstructive lesion\n11. Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated WBC or need for intravenous antibiotics.\n12. Stroke or Transient Ischemic Attack (TIA) within the 3 months prior to Screening.\n13. Primary liver disease considered to be life threatening.\n14. Renal disease or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 (as estimated by the simplified MDRD formula) at Screening or history of dialysis.\n15. Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \\\u003C 6 months.\n16. Prior (defined as less than 30 days from screening) or current enrollment in a CHF trial or participation in an investigational drug or device study within the 30 days prior to screening or 5 half-lives of the study drug, whichever is longer.\n17. Discharge for the AHF hospitalization anticipated to be \\>14 days from admission, or to a long-term care facility. Randomization must occur within 12 days following admission and at 1-2 days prior to anticipated discharge.\n18. Inability to comply with all study requirements, due to major co-morbidities, social or financial issues or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and\u002For comply with the protocol instructions or follow-up procedures.\n19. Pregnant or nursing (lactating) women.\n20. Hypersensitivity to the active substance or to any of the excipients as indicated in Summary of Product Characteristics of Investigational Medicinal Product (IMPs).\n21. Angioedema.\n22. Severe heart failure (NYHA class IV).","FEMALE","18 Years","85 Years",{"count":163,"type":164},368,"ESTIMATED","INTERVENTIONAL",[167],"PHASE4","The goal of this clinical trial is to learn whether a rapid and intensive optimization of heart failure medications in women can improve outcomes after hospitalization for heart failure. It will also investigate the safety and the tolerance of these treatments when given at full guideline-recommended doses.\n\nThe main questions it aims to answer are:\n\n1. Does intensive medication optimization reduce death or hospital readmissions for heart failure within one year?\n2. Do women benefit as much as men from intensive and full-dose heart failure therapy?\n3. Is this treatment protocol safe and feasible also in women?\n\nResearchers will compare two groups of women hospitalized for heart failure:\n\n* High-intensity care: starting and increasing all recommended heart-failure medications as quickly as possible and monitoring patients closely during the first weeks after discharge.\n* Usual care: medications are started and adjusted gradually, according to the judgment of the treating cardiologist and the patient's usual care team.\n\nThe study will follow participants for 12 months to see whether the high-intensity strategy reduces death, hospital readmission for heart failure, or worsening symptoms. It will also evaluate side effects, medication tolerance, and quality of life.\n\nParticipants will be randomly assigned to one of the two groups, attend regular follow-up visits for one year, complete a short quality-of-life questionnaire (EQ-5D).\n\nThis study will include about 360 women from 13 hospitals in Italy. It is sponsored by IRCCS Policlinico San Donato and funded by the Italian Medicines Agency (AIFA).",[170,171,172,173,174],"Heart Failure","Acute Heart Failure","Heart Failure With Reduced Ejection Fraction (HFrEF)","Heart Failure With Preserved Ejection Fraction (HFPEF)","Heart Failure With Mildly Reduced Ejection Fraction",[176,177,178,179,180,181,182,183,184],"heart failure","women","GDMT","Pharmacological Optimization","phase IV","High intensity up-titration","Secondary prevention","Sex differences","Real world data","NOT_YET_RECRUITING","2026-03-25",{"date":188,"type":189},"2026-03-30","ACTUAL",{"date":191,"type":164},"2026-04-08",{"date":193,"type":164},"2028-06-08",{"name":5,"class":6},13]