[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"decompensated-heart-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:decompensated-heart-failure":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,75,101,133,157,184,210,237],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100631885","cardiac-rehabilitation-in-decompensated-heart-failure-100631885",false,"NCT07506499","Cardiac Rehabilitation in Decompensated Heart Failure","Effect of Cardiac Rehabilitation in Patients With Decompensated Heart Failure","Inclusion Criteria:\n\n* Aged from 45 to 65 years old\n* Both sexes\n* Hospitalized heart failure patients with ejection fraction \\\u003C 40%\n* Conscious and cooperative\n* Able to participate in training actively\n\nExclusion Criteria:\n\n* Acute major cardiovascular events (e.g., acute coronary syndrome, stroke, or pulmonary embolism)\n* Uncontrolled life-threatening arrhythmias\n* Severe valvular heart disease requiring urgent surgery\n* Pregnancy\n* End-stage renal disease requiring dialysis\n* Significant pulmonary diseases such as pulmonary arterial hypertension,\n* Implanted pacemaker\n* Clinically significant peripheral vascular disease\n* Severe anemia\n* Exercise-induced angina or ST-segment changes","ALL","45 Years","65 Years",{"count":20,"type":21},135,"ESTIMATED","INTERVENTIONAL",[24],"NA","Heart failure is a common clinical condition that often leads to reduced exercise tolerance, shortness of breath, and poor quality of life. Many patients with heart failure also develop weakness of the inspiratory muscles, which contributes to limited physical activity and worsening functional capacity. Inspiratory muscle training (IMT) has been suggested as a useful rehabilitation method to improve respiratory muscle strength and exercise tolerance. In addition, functional electrical stimulation (FES) of the lower limb muscles may help activate skeletal muscles and improve functional performance in patients who cannot tolerate conventional exercise.\n\nThis randomized controlled study aims to investigate the effect of combining inspiratory muscle training with functional electrical stimulation of the lower limbs in patients with decompensated heart failure. A total of 135 hospitalized patients with decompensated heart failure will be recruited from the Cardiology Department at Beni-Suef University Hospital and randomly assigned into three groups. Group A (45 patients) will receive routine medical treatment in addition to inspiratory muscle training combined with functional electrical stimulation. Group B (45 patients) will receive routine medical treatment with inspiratory muscle training only. Group C (45 patients) will receive routine medical treatment alone.\n\nThe intervention will start during hospitalization and will continue for four weeks. The study will evaluate the effects of these interventions on cardiac function, inspiratory muscle strength, and functional capacity as primary outcomes. Secondary outcomes will include dyspnea severity, quality of life, heart rate, oxygen saturation, hand grip strength, and maximum expiratory pressure. The findings of this study may help clarify the potential role of combining inspiratory muscle training with functional electrical stimulation as part of cardiac rehabilitation in patients with decompensated heart failure.",[27],"Decompensated Heart Failure","RECRUITING","2026-04-10",{"date":31,"type":32},"2026-04-15","ACTUAL",{"date":34,"type":32},"2026-04-01",{"date":36,"type":21},"2026-07-01",{"name":38,"class":39},"Beni-Suef University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":40},"100632069","characterisation-of-phenotypes-in-acute-heart-failure-patients-100632069","NCT07508891","Characterisation of phenotYpes in aCute Heart faiLure patiEnts","CYCLE","Inclusion Criteria:\n\n* Clinical diagnosis of acute heart failure, including all stages of cardiogenic shock, de novo heart failure as well as decompensated chronic heart failure.\n* Hospitalisation due to acute heart failure or new-onset acute heart failure during a hospitalisation de to a different cause. Out-patients with acute heart failure are not included.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* No written informed consent.","18 Years",{"count":50,"type":21},1000,"10 Years","OBSERVATIONAL","An observational cohort study to evaluate the benefit of functional parameters, radiomics and blood biomarkers to predict the outcome of patients with acute heart failure.",[55,27,56],"Acute Heart Failure","Cardiogenic Shock",[58,59,60,61,62,63,64,65],"cardiogenic shock","acute heart failure","heart failure","biomarker","biobank","cohort study","phenotyping","risk prediction","2026-03-30",{"date":68,"type":32},"2026-04-02",{"date":70,"type":32},"2019-03-01",{"date":72,"type":21},"2030-12-31",{"name":74,"class":39},"Universitätsklinikum Hamburg-Eppendorf",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":18,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":40},"100627112","phase-1-vericiguat-in-decompensated-cardiac-failure-clinical-insights-on-addition-to-guidelines-derived-medical-therapy-vercig-trial-100627112","NCT07444398","Vericiguat in Decompensated Cardiac Failure: Clinical Insights on Addition to Guidelines Derived Medical Therapy-VERCIG Trial","Inclusion Criteria:\n\n* Patients diagnosed with decompensated heart failure (patients with left ventricular ejection fraction ≤45% presenting with NYHA functional class III-IV symptoms or worsening class II symptoms. Along with elevated natriuretic peptide levels defined as NT-proBNP \\>1000 pg\u002FmL in patients with sinus rhythm and \\>1600 pg\u002FmL in patients with atrial fibrillation in the absence of alternative causes of biomarker elevation)\n\nExclusion Criteria:\n\n* Patients with blood pressure \\\u003C100 mmHg;\n* concurrent or anticipated use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type 5 inhibitors\n* use of intravenous inotropes or implantable left ventricular assist devices (on medical record)","25 Years",{"count":83,"type":21},130,[85],"PHASE1","This study will compare the outcomes of Vericuguat and placebo in patient with decompensated heart failure . This study will carry out after approval from IERB. Seventy patients fulfilling the inclusion criteria will be enrolled from emergency department. Informed consent will be taken from attendants. A detailed history including name, age, gender, duration of heart failure, history of alcoholism, smoking, diabetes, hypertension, EF at baseline and NYHA class will be noted. Patients will be randomly divided in two groups by using lottery method. Outcomes will be assessed at in terms of hospitalization for heart failure, death from cardiovascular event and side effects.",[27],[89,90,91],"Vericuguat","Heart failure","Emergency Department","2026-02-26",{"date":94,"type":32},"2026-03-02",{"date":96,"type":32},"2026-01-01",{"date":98,"type":21},"2026-03-31",{"name":100,"class":39},"Khawaja Danish Ali",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":40},"100590307","use-of-point-of-care-ultrasound-pocus-to-reduce-hospital-length-of-stay-in-patients-with-heart-failure--pocushf--100590307","NCT06965712","Use of Point-of-Care Ultrasound (POCUS) to Reduce Hospital Length of Stay in Patients With Heart Failure ( POCUSHF )","Use of Point-of-Care Ultrasound (POCUS) to Guide Fluid Management and Reduce Hospital Length of Stay in Patients With Decompensated Heart Failure","POCUSHF","Inclusion Criteria:\n\nAdults aged 18 years and older.\n\nHospitalized with a primary diagnosis of decompensated heart failure (left, right, or biventricular).\n\nEvidence of volume overload or congestion based on Framingham criteria, clinical examination, elevated proBNP (\\>1000 pg\u002FmL), or chest X-ray showing pulmonary edema.\n\nAbility to undergo bedside ultrasound evaluation (POCUS) as clinically feasible.\n\nAble to provide informed consent.\n\nExclusion Criteria:\n\nAge under 18 years.\n\nPregnant or breastfeeding women.\n\nTerminal illness with life expectancy \\\u003C 30 days.\n\nInability to obtain ultrasound images due to body habitus or other technical reasons.\n\nEnrollment in another interventional clinical trial that could interfere with the outcomes of this study.",{"count":110,"type":21},66,[24],"This study will evaluate whether using bedside ultrasound (also called Point-of-Care Ultrasound or POCUS) can help improve the care of hospitalized patients with decompensated heart failure. Patients will be randomly assigned to two groups: one group will receive ultrasound-guided assessments, and the other group will receive standard clinical evaluations. Researchers will compare the hospital length of stay between the two groups. Ultrasound is a non-invasive, safe, and painless imaging tool. The goal of the study is to find out if ultrasound guidance can lead to shorter hospitalizations and better care for patients with heart failure.",[114,27,115],"Heart Failure","Hospital Length of Stay",[114,27,117,118,115,119,120,121,122,123],"Point-of-Care Ultrasound","POCUS","Ultrasound-Guided Therapy","Lung Ultrasound","Inferior Vena Cava Ultrasound","Volume Status Assessment","Readmission Prevention","2026-01-13",{"date":126,"type":32},"2026-01-14",{"date":128,"type":32},"2025-11-24",{"date":130,"type":21},"2026-06-30",{"name":132,"class":39},"Florida International University",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":40},"100606274","bioimpedance-integration-for-optimized-fluid-management-in-decompensated-heart-failure-100606274","NCT07173426","Bioimpedance Integration for Optimized Fluid Management in Decompensated Heart Failure","BIO-HF","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Patients with hospitalised with a decompensated episode of Heart Failure regardless of Ejection Fraction\n3. Able and willing to consent.\n\nExclusion Criteria:\n\n1. Patients on a palliative care pathway and\u002For estimated life expectancy \\\u003C3 months\n2. Patients admitted to ITU\u002F on intensive care support.\n3. Patients currently taking part in any trials investigating new heart failure drug or interventional treatment.\n4. Patients requiring Renal Replacement Therapy.\n5. Patients unable or unwilling to give consent.",{"count":141,"type":21},255,[24],"The goal of this clinical trial is to test whether using Bioimpedance Analysis (BIA) can help manage fluid levels in patients with heart failure who are admitted to the hospital with worsening symptoms. The main questions it aims to answer are:\n\n1\\. Does BIA-guided fluid management reduce the need for extra treatment (in the form of diuretics which helps remove excess fluid from the body) or re-hospitalization for heart failure within 90 days after discharge?\n\nResearchers will compare a group receiving BIA-guided treatment to a standard care group to see if BIA provides better results in managing fluid levels.\n\nParticipants will be randomly assigned to one of two groups:\n\nBIA-Guided Treatment Group: Have BIA measurements done within 24 hours of admission and throughout their hospital stay to guide diuretic treatment.\n\nStandard Care Group: Have BIA measurements taken at admission and discharge, but the results will not be shared with the clinical team, who will manage fluid levels as usual.\n\nAll patients will attend a follow-up visit in 2-4 weeks after discharge where the patient will undergo standard health checks, blood tests, and a questionnaire about how heart failure affects their quality of life.\n\nThe investigators will then compare both groups for the primary outcome measure, which is the rates of rehospitalisation or need for additional decongestive treatment, within 90 days of discharge from hospital.",[114,27],[146,27,147],"Bioimpedance Analysis","Fluid Assessment","2025-09-12",{"date":150,"type":32},"2025-09-15",{"date":152,"type":32},"2024-12-30",{"date":154,"type":21},"2026-12-01",{"name":156,"class":39},"Mid and South Essex NHS Foundation Trust",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":183},"100592142","bioconceptbiomonitor-hf-collect-clinical-data-from-heart-failure-patients-using-biomonitor-devices-with-a-study-specific-research-software-100592142","NCT06989580","BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software","Clinical Data Collection to Develop Improved Arrhythmia and Heart Failure Management Using BIOMONITOR","Inclusion Criteria:\n\n* Patient has diagnosed heart failure for ≥90 days and current symptoms compatible with NYHA class II-III (according to most recent assessment)\n* At least ONE of the following:\n\nAt least one documented admission with a primary diagnosis of worsening heart failure within last 12 months prior to enrollment;\n\nOR Unscheduled outpatient visit with increase of oral loop diuretics (more than 2-fold) or IV diuretic or ultrafiltration therapy for acute WHF within last 6 months prior to enrollment;\n\nOR elevated NT-proBNP\u002FBNP values within last 3 months prior to enrollment i.e.:\n\nIf LVEF \\>50% --\\> Patients in SR: \\>450 \u002F \\>150 pg\u002Fml; Patients with AF present: \\>900 \u002F \\>300 pg\u002Fml\n\nIf LVEF \\\u003C50% --\\> Patients in SR: \\>900 \u002F \\>300 pg\u002Fml; Patients with AF present: \\>1800 \u002F \\>450 pg\u002Fml\n\n* Ability to understand the nature of the study\n* Willingness to provide written informed consent\n* Ability and willingness to perform follow-up visits at the study site and via phone\n* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept\n\nExclusion Criteria:\n\n* Implanted with pacemaker, ICD or CRT device or ICM\n* Class I indication for a pacemaker, ICD or CRT according to current guidelines.\n* Permanent or long-standing persistent AF\n* Stroke, MI or PCI\u002FCABG within 3 months prior to enrollment\n* Patient is on chronic renal or peritoneal dialysis\n* Patient has complex adult congenital heart disease\n* Patient has active cancer involving chemotherapy, immunotherapy or radiation therapy\n* Patient life expectancy is less than 1 year\n* Age \\\u003C18 years\n* Patient is participating in any other device or drug trial that may interfere with the treatment or protocol of this study or may significantly affect the study outcomes",{"count":165,"type":21},300,[24],"\\[Plain language\\]: Heart failure (HF) patients often experience irregular heartbeats, known as arrhythmias. Atrial fibrillation (AF) is common among HF patients and can worsen their condition, leading to strokes and higher death rates. Most of what we know about arrhythmias in HF comes from patients with devices like ICDs or CRTs, which help manage heart rhythms. However, this study focuses on HF patients who don't qualify for these devices.\n\nResearchers use the BIOMONITOR IV, a device that tracks heart activity remotely over a long period. The goal is to understand how often arrhythmias occur in these patients and to develop a predictive algorithm for worsening HF (WHF). This algorithm could help doctors intervene early and improve treatment, reducing hospital visits and deaths related to WHF.\n\nTo make the BIOMONITOR IV more effective for HF management, its firmware is updated to collect additional data, such as fluid levels, breathing rate, and body position. These factors may be important for predicting WHF events.",[114,169,27,170],"Arrhythmia","Atrial Fibrillation",[172],"Worsening Heart Failure (WHF)","2025-09-05",{"date":175,"type":32},"2025-09-08",{"date":177,"type":32},"2025-08-22",{"date":179,"type":21},"2028-12-31",{"name":181,"class":182},"Biotronik SE & Co. KG","INDUSTRY",2,{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":190,"targetDuration":192,"studyType":52,"phases":4,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":40},"100546660","a-prospective-observational-single-centre-study-to-assess-the-feasibility-of-the-data-harvested-by-the-acorai-intracardiac-pressure-monitoring-icpm-system-in-predicting-prognosis-in-patients-discharged-from-hospital-after-treatment-for-acute-decompensated-heart-failure-100546660","NCT06397833","A Prospective, Observational, Single Centre Study to Assess the Feasibility of the Data Harvested by the Acorai Intracardiac Pressure Monitoring (ICPM) System in Predicting Prognosis in Patients Discharged From Hospital After Treatment for Acute Decompensated Heart Failure","Inclusion Criteria: Subjects must meet all the following criteria to be eligible for participation in the clinical investigation\n\n1. Subjects medically fit for discharge following an admission to Hospital with decompensated heart failure requiring intravenous diuretic therapy\n2. Subject is willing and physically able to comply with the specified evaluations as per clinical investigation plan, as assessed by the investigator.\n3. Subject is able to provide written consent to participate in the study\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Discretionary exclusion when, in the opinion of the investigator, the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the clinical trial",{"count":191,"type":21},150,"1 Year","Acorai is developing the Acorai Heart Monitor, a handheld electronic device for monitoring pressures inside the heart in a non-invasive manner, by placing the device on the chest of a patient. Currently these intracardiac pressures are measured in an invasive way, during a right heart catheterisation procedure. This procedure carries risks to the patient. There is a clinical need for a non -invasive, easy to use, tool to monitor patients that suffer from heart failure. The study aim is to use the Acorai device to collect the intracardiac pressure measurements from patients admitted to hospital with heart failure and who are awaiting discharge home. Using the data, we will assess the feasibility of the Acorai derived cardiac output measurements, and assess what data best predicts survival, death, or major adverse cardiac events (MACE)",[114,27],[60,196,197,198,199,200],"decompensated heart failure","acorai","artificial intelligence","machine learning generisation","machine learning generization","2025-04-04",{"date":203,"type":32},"2025-04-08",{"date":205,"type":32},"2024-04-29",{"date":207,"type":21},"2027-02-01",{"name":209,"class":39},"Royal Brompton & Harefield NHS Foundation Trust",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":221,"conditions":222,"keywords":224,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":40},"100538099","phase-4-colchicine-in-acutely-decompensated-hfref-100538099","NCT06286423","Colchicine in Acutely Decompensated HFREF","Colchicine in Acutely Decompensated Heart Failure With Reduced Ejection Fraction: a Pilot Study","Inclusion Criteria:\n\n1. Primary admission diagnosis of acute decompensated heart failure as evidenced by:\n\n   * Heart failure symptoms and at least one of the following:\n   * Pulmonary congestion\u002Fedema at physical exam (or chest radiography)\n   * E\u002Fe' \\> 13 on transthoracic echocardiography\n   * Left heart catheterization showing elevated left ventricular (LV) end-diastolic pressure \\>18 mmHg or right heart catheterization showing pulmonary artery occluding pressure (wedge) \\>16 mmHg\n   * Elevated plasma B-type natriuretic peptide (\\>100 pg\u002Fml) or N-terminal B-type natriuretic peptide (\\>300 pg\u002Fml)\n2. LV systolic dysfunction (left ventricular ejection fraction \\[LVEF\\] \\\u003C40%) during the index hospitalization or prior 12 months;\n3. Expected duration of heart failure at least three months\n4. Age 18 years or older\n5. Willing and able to provide written informed consent\n6. Screening plasma CRP \\>0.3 mg\u002FdL (3 mg\u002FL) or high-sensitivity CRP \\>2 mg\u002FL\n\nExclusion Criteria:\n\n1. Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study, including but not limited to acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration\n2. Cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries performed within 3 months or planned during the admission\n3. Previous or planned implantation of left ventricular assist devices or heart transplantation\n4. Chronic use of intravenous inotropes\n5. Current or recent (i.e. within 4 half-lives) use of immunosuppressive or anti-inflammatory drugs (not including NSAIDs).\n6. Current treatment with colchicine or planned initiation of colchicine therapy in the next three months for gout\n7. Chronic inflammatory disorder, including but not limited to rheumatoid arthritis and systemic lupus erythematosus\n8. Active infection (of any type)\n9. Chronic or recurrent infectious disease, including hepatitis B virus, hepatitis C virus, and HIV\u002FAIDS\n10. Prior (within the past 5 years) or current malignancy, with the exclusion of in situ lesion with low potential for progression\n11. Any comorbidity leading to expected survival less than three months or inability to complete the study\n12. End-stage kidney disease requiring renal replacement therapy\n13. Neutropenia (\\\u003C2,000\u002Fmm3) or Thrombocytopenia (\\\u003C50,000\u002Fmm3)\n14. Pregnancy\n\n    * For all biological females with child bearing potential a pregnancy test will be performed as part of standard of care.\n15. Presence of specific contraindications to colchicine treatment, which may include\n\n    * Previous adverse reaction to colchicine\n    * Biliary obstruction\n    * Renal impairment with estimated glomerular filtration rate (eGFR) \\\u003C30 ml\u002Fmin\n    * Liver cirrhosis from stage Child-Pugh A to more advanced\n16. Prisoners\n17. Treatment with medication contraindicated for concomitant use with colchicine per\n\nFood and Drugs Administration labeling, including:\n\n* Protease inhibitors\n* Macrolides antibiotic\n* Ketoconazole, Fluconazole and Itraconazole\n* Nefazodone\n* Non-dihydropiridine calcium channel blockers\n* Aprepitant\n* Ranolazine\n* Cyclosporine",{"count":218,"type":21},30,[220],"PHASE4","This is a double blind, placebo-controlled pilot trial randomizing patients admitted to the hospital with acutely decompensated heart failure (ADHF) and inflammation to receive either colchicine or matching placebo.\n\nUpon enrollment, patients will be randomized 1:1 to receive either the experimental drug (Colchicine) or matching placebo. The regimen in the active arm will consist of 14 days of Colchicine 0.6 mg bid followed by 76±14 days of Colchicine 0.6 mg once per day. Placebo regimen will be analogous, with one pill bid for 14 days followed by one pill once per day for 76 days. Dose reduction for patients with Stage III chronic kidney disease is allowed as detailed in the protocol. At the same time, dose reduction can also be elected in case of GI symptoms. The study team will transiently stop the experimental medication in case of acute kidney injury (AKI), defined per Kidney Disease Improving Global Outcomes (KDIGO) Stage I, as specified in the protocol.\n\nThese patients will continue with their standard of care for the management of heart failure which consists of a combination of medications that relieve congestion, normalize blood pressure and heart rate, and block the effects of hormones on the heart. The proposed treatment will be in addition to standard of care. No standard of care medications will be withheld. While inflammation is a known risk factor in heart failure, there are no standard anti-inflammatory drugs used in patients with heart failure, as the benefit is not established. The study team will study colchicine, an anti-inflammatory drug, as compares with placebo.\n\nBlood will be obtained from the patients in order to measure hsCRP and IL-6. Blood samples will be collected at baseline, 24±6h, 48±6h and 72±6h after treatment initiation, and subsequently at 14±7 days and at study closure. The first four blood samples will be obtained while the subject is still admitted to the hospital. The blood sample at 14±7 days will be obtained during an outpatient encounter. A study closure visit with clinical assessment and experimental drug collection for capsule counting to assess compliance will be conducted at 90±14; the final blood sample will be collected at that time.",[114,27,223],"Heart Failure With Reduced Ejection Fraction",[225,114,27,226,227],"Colchicine","Heart Failure with Reduced Ejection Fraction","HFrEF","2024-05-06",{"date":230,"type":32},"2024-05-08",{"date":232,"type":21},"2024-06",{"date":234,"type":21},"2028-06",{"name":236,"class":39},"University of Virginia",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":253,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":4},"100537097","acetazolamide-or-metolazone-in-acute-heart-failure-100537097","NCT06273397","Acetazolamide or Metolazone in Acute Heart Failure","ACME-AHF","Inclusion Criteria:\n\n* Acute heart failure: Hospitalization due to symptoms of heart failure, congestion signs documented with a congestion score greater than 1, NT-proBNP above 1000 pg\u002Fml.\n* Randomization within 24 hours of admission.\n\nExclusion Criteria:\n\n* Under 18 years of age.\n* Received more than one dose of intravenous furosemide before randomization.\n* Cause of heart failure: hypertrophic or restrictive cardiomyopathy, or constrictive pericarditis.\n* Acute coronary syndrome or severe acute valvulopathy as the cause of decompensation.\n* Systolic blood pressure \\\u003C 90mmHg before randomization.\n* Requirement for vasopressors, inotropes, or invasive mechanical ventilation. Use of intravenous vasodilators or non-invasive mechanical ventilation is allowed.\n* Glomerular filtration rate \\\u003C 20ml\u002Fmin\u002F1.73m2.\n* Potassium \\\u003C 2.5 mEQ\u002FL or Sodium \\\u003C 125 mEQ\u002FL before randomization.\n* pH \\\u003C 7.2 or Bicarbonate \\\u003C 15mEQ\u002FL before randomization.\n* Use of another diuretic in addition to furosemide before randomization. Dapagliflozin or Empagliflozin can be maintained upon admission or initiated early during hospitalization if desired by the treating physician (variable to be recorded).\n* Patients who cannot achieve adequate recording of variables (e.g., inability to quantify diuresis or weight).\n* Pregnant or lactating individuals. If of childbearing age and there is inconsistency with contraceptive use or reasonable doubts about current pregnancy, a pregnancy test must be conducted before study entry.",{"count":245,"type":21},1050,[24],"Impact of Acute Heart Failure:\n\nAccording to the World Health Organization (WHO), approximately 26 million people suffer from Heart Failure (HF), with a mortality rate of up to 50% within five years of diagnosis. Acute Heart Failure (AHF) exacerbations, leading to hospitalization, are common and represent the primary cause of hospital admissions in those over 65. Effective decongestion during hospitalization is crucial, as failure to achieve it doubles the risk of rehospitalization and mortality, incurring significant healthcare costs.\n\nUse of Diuretics in Acute Heart Failure:\n\nDiuretics, particularly loop diuretics like furosemide, are a cornerstone in managing AHF by inducing natriuresis and achieving decongestion. Clinical experience supports their use, though limited clinical trials exist. Pharmacological concepts guide their administration, emphasizing intravenous delivery in high doses and adjusting subsequent doses based on decongestive efficacy. Additionally, sequential tubular blockade with other diuretics like metolazone and acetazolamide is explored to enhance decongestion.\n\nUse of Metolazone and Acetazolamide:\n\nSequential tubular blockade, using metolazone and acetazolamide in conjunction with furosemide, aims to achieve rapid and effective decongestion. While metolazone targets the distal tubule, inhibiting sodium-chloride channels, acetazolamide affects proximal tubular function. Studies like ADVOR (acetazolamide) and CLOROTIC (thiazide-like diuretic) demonstrate the potential benefits of combining these diuretics for quicker decongestion but with potential risks (in the case of Hydrochlorothiazide).\n\nOutcomes Measured by Major Studies:\n\nRecent studies assessing decongestion in AHF reveal a lack of uniformity in outcome selection. The primary focus should be on reducing rehospitalizations and post-discharge mortality by achieving effective decongestion. The ADVOR study, using a simple congestion score based on clinical and imaging criteria, underscores the importance of reaching a congestion score of 0 or 1 promptly.\n\nCongestion Monitoring:\n\nMonitoring diuretic treatment solely based on clinical aspects may not capture subclinical congestion, necessitating biochemical and imaging parameters. The ACME-AHF trial proposes a diagnostic score integrating clinical and imaging aspects to evaluate congestion status. Secondary outcomes include cumulative diuresis, weight loss, diuretic efficiency, and natriuresis, with a focus on natriuresis as a reliable physiological parameter for decongestion.\n\nAim of the study:\n\nThe ACME-AHF trial is designed to compare the efficacy and safety of two diuretic combination strategies: acetazolamide with furosemide and metolazone with furosemide. The primary objective is to relieve congestion, assessed using a congestion score, within the first three days of treatment during an hospitalization for acute heart failure.",[249,27],"Heart Failure Acute",[251,252,249],"Acetazolamide","Metolazone","NOT_YET_RECRUITING","2024-03-14",{"date":256,"type":32},"2024-03-18",{"date":258,"type":21},"2024-05-01",{"date":260,"type":21},"2027-05-01",{"name":262,"class":39},"Clinica Alemana de Santiago"]