[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-heart-failure-with-reduced-ejection-fraction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-heart-failure-with-reduced-ejection-fraction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100561832","vietnamese-rapid-acceleration-protocol-for-intensifying-drug-therapy-in-heart-failure-with-reduced-ejection-fraction-100561832",false,"NCT06595290","Vietnamese Rapid Acceleration Protocol for Intensifying Drug Therapy in Heart Failure With Reduced Ejection Fraction","VN-RAPID","Inclusion Criteria:\n\n1. Hospital admission with diagnosis of acute heart failure assessed by clinical signs and symptoms of congestion and radiographic, biological tests (if admitted with acute coronary syndrome, required at least Killip class II or clear evidence of congestion on admission assessed by chest x-ray or lung ultrasound and\u002For pulmonary congestion requiring intravenous treatment)\n2. Female or male patients ≥ 18 years old\n3. At randomization:\n\n   1. Systolic blood pressure \\> 90 mmHg (at least 2 measurements on 2 different occasions) and\n   2. Heart rate ≥ 60 bpm (at least 2 measurements on 2 different occasions) and\n   3. Serum potassium ≤ 5.0 mmol\u002FL\n4. Left ventricular ejection fraction (LVEF) ≤ 40% assessed locally by Simpson's Biplane method via echocardiography (if multiple LVEF measurements, the last one performed prior to randomization should be considered as the qualifying measurement)\n5. Persistent congestion at the time of randomization with pre-discharge NT-proBNP ≥ 1500 ng\u002FL\n6. HFrEF medications at randomization:\n\n   1. ≤ ¼ RASi\u002FARNi target dose and\n   2. ≤ ¼ beta-blocker target dose and\n   3. ≤ ½ MRA dose\n7. Obtained written informed consent form\n\nExclusion Criteria:\n\n1. Clearly documented intolerance to high doses of RASi\u002FARNi or beta-blockers\n2. Absolute contraindication to usage of RASi\u002FARNi or beta-blocker or MRA or SGLT2i as per ESC 2021\u002FACC 2022 Heart failure guideline\n3. LVEF \\>40% assessed by echocardiography on the latest measurement prior to discharge\n4. Renal disease or eGFR \\< 30 mL\u002Fmin\u002F1.73m2 (as estimated by the CKD-EPI 2021 or the simplified MDRD) at Screening or history of dialysis.\n5. Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1\\< 1 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.\n6. Implantation of cardiac resynchronization device or underwent coronary artery bypass graft surgery within 3 months\n7. Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous coronary intervention (PCI), within 1 month prior to Screening.\n8. AHF triggered primarily by a correctable etiology 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 \\<45 beats per minute), infection, severe anemia, pulmonary embolism, exacerbation of 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.\n9. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.\n10. History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.\n11. Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.\n12. 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 of the left ventricular outflow tract.\n13. Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated WBC or need for intravenous antibiotics.\n14. Stroke or TIA within the 3 months prior to Screening.\n15. Primary liver disease considered to be life threatening.\n16. Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \\< 6 months.\n17. 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\n18. 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 within 2 days prior to anticipated discharge.\n19. Inability to comply with all study requirements, due to major comorbidities, 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\n20. Pregnant or nursing (lactating) women.","ALL","18 Years","75 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"NA","VN-RAPID is an open-label, multicenter, randomized controlled trial evaluating the safety and efficacy of in-hospital initiation and rapid up-titration of four-pillar therapy for hospitalized Asian patients with acute heart failure (AHF) and reduced ejection fraction (HFrEF). The study compares a standardized protocol of intensified treatment (high-intensity care arm) with usual care in patients with elevated NT-proBNP levels who are not on optimal HFrEF medications. The high-intensity care arm involves initiation of all four pillars of HFrEF therapy (RAS inhibitor, beta-blocker, MRA, and SGLT2i) before discharge, followed by a structured 6-week outpatient up-titration process with frequent follow-ups. The study aims for 75% of target doses for RAS inhibitors and beta-blockers, considering the lower blood pressure tendency in Asian populations. Participants will be followed for 180 days to assess clinical outcomes.",[27,28],"Acute Heart Failure (AHF)","Acute Heart Failure With Reduced Ejection Fraction",[30,31,32,33],"HFrEF","STRONG-HF","Acute heart failure","Rapid uptitration","RECRUITING","2025-07-31",{"date":37,"type":38},"2025-08-05","ACTUAL",{"date":40,"type":38},"2025-08-01",{"date":42,"type":21},"2029-01-01",{"name":44,"class":45},"University Medical Center Ho Chi Minh City (UMC)","OTHER",4,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":46},"100571888","the-focus-adhf-registry-100571888","NCT06726109","The FOCUS-ADHF Registry","a FOCUSed Prospective Registry on Acute Decompensation of Heart Failure With Reduced Ejection Fraction- The FOCUS-ADHF Registry","FOCUS-ADHF","Inclusion Criteria:\n\n* Patients within 24h since admission for an acute decompensation of heart failure (ADHF)\\* (both acute on chronic and de novo) defined as\n\n  1. signs and symptoms of volume overload with necessity of iv diuretic treatment.\n  2. and NT-proBNP (N-terminal pro-B-type natriuretic peptide) \\>1500 pg\u002FmL or a B-type natriuretic peptide level of \\>500 ng\u002FmL.\n\nAND ALL THE FOLLOWING echo entry criteria at admission:\n\n1. A dilated left ventricle (defined as a indexed LVEDD ≥ 31 mm\u002Fsm and ≥ 32 mm\u002Fsm or a indexed LVEDVol ≥ 75 ml\u002Fsm and ≥ 62 ml\u002Fsm in men and women respectively) AND\u002FOR at least moderate functional mitral regurgitation (FMR).\n2. Reduced ejection fraction (\\\u003C40%)\n3. Increased LV filling pressure (defined as II°-III° Diastolic dysfunction) AND increased pulmonary artery pressure (i.e. echo estimated systolic pulmonary artery pressure \\[sPAP\\] ≥ 40 mmhg and\u002For echo estimated mean pulmonary artery pressure \\[mPAP\\] ≥ 20 mmHg).\n\nExclusion Criteria:\n\n* Patients presenting in Cardiogenic shock defined as hypotension (SBP \\\u003C 90mmHg or MAP ≤ 55) AND hypoperfusion (defined as arterial lactates \\> 4 mmol\u002FL)\n* Estimated GFR \\\u003C=20 ml\u002Fmin\u002F1.73 m2 or in chronic renal replacement therapies.\n* End-stage hepatic impairment\n* Use of temporary mechanical support at the moment of study inclusion or planned to use it within hours (IABP; Impella, VA ECMO)\n* Ongoing treatment with vasopressors\u002Finotropes at the moment of randomization or administration of Levosimendan within 30 days before randomization. Patients admitted for a planned cycle of Levosimendan infusion will be excluded by the present study as well.\n* AHF secondary to recent onset tachy-arrhythmias\n* ST tract elevated myocardial infarction (STEMI) \\\u003C 30 days, myocarditis \\\u003C30 days, AHF due to severe primary valve disease or clinical suspicion of an acute mechanical cause of AHF\n* restrictive cardiomyopathy, constrictive pericarditis, hypertrophic obstructive cardiomyopathy, tako-tsubo syndrome\n* Infective endocarditis, concomitant active septic disease as predominant cause of decompensation or admission TC\\>38°c.\n* LVAD carriers or Heart transplant recipients\n* Terminal illness other than heart failure with an expected survival \\\u003C180 days",{"count":56,"type":21},600,"3 Months","OBSERVATIONAL","Acute heart failure (AHF) represents a significant clinical and economic burden due to its impact on patients' quality of life, poor prognosis, and high healthcare costs. Despite advancements in treatment, the optimal therapeutic management of these patients, particularly those with severely reduced ejection fraction and dilated left ventricles, remains uncertain. The last European Society of Cardiology (ESC) guidelines gave a weak recommendation for using intravenous (IV) vasodilators in patients with adequate systolic blood pressure. This is derived from heterogeneous randomized controlled trials (RCTs) enrolling all-comers heart failure patients. Those studies did not specifically target conditions that from a pathophysiological perspective might derive potential positive response from vasodilators like left ventricle dilatation, significant mitral regurgitation and\u002For increased filling pressure. Patients with such characteristics show higher myocardial wall tension and are particularly vulnerable to afterload increases, positioning them as optimal candidates for vasodilator therapy during acute decompensation. Little evidence is available from real world cohort study on the benefit of vasodilators in this group of patients. Many of these studies used pre-defined protocol and invasive hemodynamic monitoring. On the contrary the use of echocardiographic evaluation to phenotype, infer hemodynamic parameters and assess treatment effect has become the most common adopted technique in real life.\n\nThe present prospective registry aims to investigate acute treatment management and outcomes in a focused population of patients admitted for an acute decompensation of heart failure (ADHF) with severely reduced ejection fraction and dilated left ventricle or significant functional mitral regurgitation.\n\nInclusion Criteria:\n\n* Patients within 24h since admission for an ADHF defined as\n\n  1. signs and symptoms of volume overload with necessity of iv diuretic treatment.\n  2. and NT-proBNP (N-terminal pro-B-type natriuretic peptide) \\>1500 pg\u002FmL or a B-type natriuretic peptide level of \\>500 ng\u002FmL.\n\n     • Admission echocardiography with evidence of a dilated left ventricle and\u002For at least moderate functional mitral regurgitation (FMR), reduced ejection fraction (\\\u003C40%), increased LV (II\u002FIII degree diastolic dysfunction) and pulmonary pressure (sPAP ≥ 40 mmHg or MPAP ≥ 20 mmHg).\n\n     Exclusion Criteria:\n\n     \\- Cardiogenic shock at admission warranting immediate MCS \u002F inotropic support, severe renal or hepatic impairment, recent myocardial infarction, and other terminal illnesses.\n     * Use of vasopressors\u002Finotropes or mechanical support at admission. Methods Patients will receive treatments according to their physician's discretion based on ESC guidelines. Serial evaluations of heart function will be conducted using echocardiography and lung ultrasound (LUS) at multiple time points as well as hemodynamic data, laboratory and HF medications' prescription and dosages Primary endpoint\n\n       * 3 months incidence of need of Heart Replacement Therapies (LVAD or heart transplantation) and\u002For heart failure re-hospitalization and\u002For all-cause death.\n\n     Secondary endpoints • In hospital and 3 months All-cause death\n\n     • All cause and HF related hospitalizations within 3 months\n\n     • Heart replacement therapies (LVAD or heart transplantation) within 3 months.\n\n     • In hospital Worsening Heart Failure (WHF)\n\n     • Need of renal replacement therapy (RRT) within 3 months\n\n     • In-hospital length of stay (days), NT-proBNP variations, GDMT and diuretics prescription and dosages up to three months;\n\n     Objectives:\n\n  \u003C!-- -->\n\n  1. To describe the acute therapeutic management and discharge prescriptions for heart failure medications, including doses, in a selected population with ADHF.\n  2. To evaluate clinical outcomes and NT-proBNP variation in relation to initial intravenous medications, particularly comparing the use versus non-use of vasodilators.\n  3. To identify the incidence and timing of a significant therapeutic response through serial evaluations of LUS and echo-derived parameters, and to examine their association with the initial intravenous medications prescribed.\n  4. To investigate the association between the criteria for therapeutic response and clinical outcomes in both short- and medium-term follow-up, with a focus on the relationship to the initially administered therapy.",[28,61,62],"Decompensation; Heart, Congestive","Regurgitation, Mitral",[27,64,65,66,67,68,69,70,71,72,73,74],"Acute Decompensated Heart Failure (ADHF)","Vasodilators","Dilated left ventricle","reduced ejection fraction (rEF)","functional mitral regurgitation (FMR)","increased filling pressure","increased pulmonary artery pressure","nitroprusside","sodium nitroprusside","Isosorbide Dinitrate","nitroglycerine","2025-05-02",{"date":77,"type":38},"2025-05-06",{"date":79,"type":38},"2025-04-27",{"date":81,"type":21},"2030-08",{"name":83,"class":45},"ASL Città di Torino"]