[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Consorcio Centro de Investigación Biomédica en Red (CIBER)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":124},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,81,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100628889","exercise-for-an-aging-liver-exaliver-100628889",false,"NCT07467512","Exercise for an Aging Liver (EXALIVER)","Evaluation of the Impact of Physical Exercise on Metabolic Dysfunction-associated Steatotic Liver Disease in the Elderly","EXALIVER","Inclusion Criteria:\n\n* Middle-aged adults (40 to 60 years old) and older adults (aged 70 years or older)\n* People diagnosed with Metabolic Disfunction-Associated Steatotic Liver Disease (MASLD); defined as the presence of hepatic steatosis (≥5% fat content) in conjunction with at least one cardiometabolic risk factor (overweight or obesity, dysglycaemia or Type II diabetes, elevated plasma triglycerides, reduced HDL-cholesterol or high blood preassure) with no other discernable cause.\n* People diagnosed with at-risk Metabolic Disfunction-Associated SteatoHepatitis (MASH) according to the following criteria: I) a positive liver biopsy (NAS score ≥ 4 points (with at least one point in each of the components of the score: steatosis, lobular inflammation and ballooning, AND significant (F2) or advanced (F3) fibrosis), or II) a FAST score \\>0.65.\n\nExclusion Criteria:\n\n* Descompensated cirrhosis or end-stage liver disease.\n* Other causes of liver disease, such as alcohol abuse or drug-induced, virus-related, or hereditary disease.\n* History of a major adverse cardiovascular event, clinically significant kidney, endocrine, or neurological disease, bariatric surgery, HIV\u002FAIDS, known inflammatory and\u002For rheumatologic disease, cancer, or other medical condition in which exercise is absolute contraindicated.\n* Recent or planned major surgery, as well as anticancer therapies.\n* Participating in a weight loss, a weight-management program or a supervised exercise program (more than 30 minutes three times per week, or 45 minutes twice a week, moderate\u002Fvigorous intensity).\n* Body weight instability. Participants must have maintained the body weight registered at screening visit (tolerance: 5%) for more than 3 months.\n* Regular use of medication or compounds that may affect study outcomes based on research staff criteria.\n* Pregnancy and lactation or planned pregnancy (within the study period).\n* Frequent travel over time zones during the study period.\n* Fear of needles and claustrophobia to magnetic resonance imaging (MRI).\n* Low physical function (ie, ambulation dependency)\n* Being unable to understand and to accept the instructions or the study objectives and protocol.","ALL","40 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn how physical exercise affects liver health in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) or at-risk metabolic dysfunction-associated steatohepatitis (MASH); comparing responses between middle-aged adults (40-60 years old) and older adults (70 years and older) of any sex, as well as between participants with low-risk MASLD and high-risk MASH. The main question it aims to answer is:\n\nCould an exercise program reduce liver fat, inflammation and fibrosis, regardless of age and disease severity?\n\nResearchers will compare 4 different groups:\n\nA) older adults with at risk MASH who will exercise B) middle-aged people with at risk MASH who will exercise C) middle-aged people with low-risk MASLD who will exercise D) middle-aged people with low-risk MASLD who will not exercise, receiving usual care.\n\nParticipants in the exercise groups will take part in a supervised 12-week exercise program that includes both strength and aerobic training, completed twice a week.\n\nAll participants, including those receiving usual care, will have health asssessments before and after the 12-week period to measure changes in liver health.",[27,28,29],"MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","MASH - Metabolic Dysfunction-Associated Steatohepatitis","Liver Fibrosis\u002FNASH","NOT_YET_RECRUITING","2026-03-09",{"date":33,"type":34},"2026-03-12","ACTUAL",{"date":36,"type":21},"2026-03",{"date":38,"type":21},"2027-10",{"name":40,"class":41},"Consorcio Centro de Investigación Biomédica en Red (CIBER)","OTHER_GOV",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100498408","phase-3-efficacy-of-esmolol-in-the-identification-of-cardiovascular-disorders-by-cirrhosis-diabetes-mellitus-and-cardiotoxic-treatments-100498408","NCT05769868","Efficacy of Esmolol in the Identification of Cardiovascular Disorders by Cirrhosis, Diabetes Mellitus and Cardiotoxic Treatments","Prospective, Multicenter and Open Study to Evaluate the Efficacy of Esmolol in the Early Identification of Cardiovascular Disorders Induced by Cirrhosis, Diabetes Mellitus and Cardiotoxic Treatments","CIBERbBECHO","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Absence of previous heart disease, defined as the absence of relevant cardiac structural alterations such as moderate or severe hypertrophy, alteration of segmental contraction, Moderate or severe valvular disease, intraventricular obstructive gradient, or old myocardial infarction.\n3. Existence of an at least acceptable ultrasonic window, which allows the visualization of at least 14 of the 17 segments of the LV myocardium.\n4. Sinus rhythm, with a basal heart rate greater than 50 bpm.\n5. Diabetic patients with a diagnosis of Diabetes Mellitus 2 (DM2) with or without Heart Failure with Normal Ejection Fraction (HFNEF) (n = 300) will be included. Previous diagnosis of HFNEF with clinical stability at the time of inclusion (n = 200). No previous diagnosis of HFNEF (n = 100).\n6. 200 patients with cirrhosis stratified by the following additional criteria will be included: Child-Pugh A class (n = 25); Child-Pugh B class (n = 75); Child-Pugh C class (with and without ascites n = 50 and n = 50, respectively).\n7. 300 cancer patients will be included, divided into 3 therapeutic groups: 125 patients diagnosed with Lymphoma or Sarcoma receiving chemotherapy based on anthracyclines at high doses (≥ 240 mg \u002F m2); 125 patients with Human Epidermal growth factor Receptor 2 (HER2) positive breast cancer receiving chemotherapy regimen that includes trastuzumab without anthracyclines; 50 patients with hepatocarcinoma receiving treatment with Sorafenib.\n8. Expected survival\\> 6 months, first-diagnosis of cancer, and receiving treatment with chemotherapy that includes any of the previous schemes.\n9. A control group (n = 200) without heart disease and without any of the study conditions will be included: diabetes from any cause, cancer or active cancer treatment or some degree of liver disease.\n\nExclusion Criteria:\n\n1. Contraindication for the administration of esmolol (according to technical data sheet): Hypersensitivity to esmolol hydrochloride; Severe sinus bradycardia (HR \\\u003C50 bpm); 2nd or 3rd degree atrioventricular block without pacemaker; Cardiogenic shock, severe hypotension, or decompensated heart failure; Untreated pheochromocytoma; Acute asthmatic attack; Concomitant intravenous administration or within the first 48 hours after verapamil.\n2. Treatment with beta-blocker drugs (oral, topical or intravenous) in the last 7 days before the study.\n3. History of ventricular or supraventricular arrhythmias that prevent the safe withdrawal of antiarrhythmic or braking treatment before the administration of esmolol.\n4. History of previous high-grade atrioventricular (AV) conduction disorder in non-pacemaker patients.\n5. Severe asthma with bronchial hyperresponsiveness.\n6. Patients with acute infection.\n7. Participants in other clinical trials in the 30 days prior to the start of the study.\n8. Pregnant women, or who plan to be, and women during breastfeeding.\n9. Patients with limitation to follow the protocol for any reason.\n10. Diagnosis of Diabetes Mellitus (DM) of any type other than type 2 \\[type 1, Latent Autoimmune Diabetes in Adults (LADA), Maturity-Onset Diabetes of the Young (MODY), New Onset Diabetes After Transplant (NODAT), etc.\\]\n11. Patients in New York Heart Association (NYHA) functional class IV or with advanced heart failure.\n12. Treatment with an oral beta-blocker at the time of the examination that cannot be safely temporarily suspended 72 hours before the test.\n13. Active evidence of Hepatitis B Virus (HBV) or Hepatitis B Virus (HCV) infection.\n14. Personal history of previous cancer requiring systemic treatment (excludes skin or localized cancers treated locally surgically).\n15. Previous exposure to systemic antitumor treatment or radiotherapy on the thoracic region.",true,"18 Years",{"count":54,"type":21},1000,[56],"PHASE3","The purpose of this study is to assess the superiority of esmolol echocardiography over conventional echocardiography in the diagnosis of subclinical myocardial involvement associated with diabetes mellitus 2, cirrhosis and antineoplastic treatments.",[59,60,61],"Cirrhosis","Diabetes Mellitus","Oncologic Disorders",[63,64,65,66,67,68,69,70],"beta blockers","echocardiography","esmolol","systolic function","cardiovascular diagnosis","biomarkers","diagnostic techniques","medical imaging","RECRUITING","2024-09-30",{"date":74,"type":34},"2024-10-01",{"date":76,"type":34},"2023-04-18",{"date":78,"type":21},"2027-09",{"name":40,"class":41},6,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100557110","phase-3-fecal-microbiome-transplantation-in-cirrhosis-trial-in-patients-with-decompensated-cirrhosis-100557110","NCT06533852","Fecal Microbiome Transplantation in Cirrhosis: Trial in Patients With Decompensated Cirrhosis","Fecal Microbiome Transplantation in Cirrhosis: Randomized, Double-blinded, Placebo-Controlled Trial in Patients With Decompensated Cirrhosis","LiverGut","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and\u002For histology. Cirrhosis of any etiology may be included except from patients with cirrhosis due to autoimmune hepatitis, and patients with cirrhosis due to cholestatic liver disease can only be included in the study if they present clinical decompensation of cirrhosis (i.e. ascites).\n3. Child-Pugh B or C patients (7- up to 12 points).\n4. Women of child-bearing potential\\* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence\\*\\* (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.\n\nExclusion Criteria:\n\n1. Previous history of gastrointestinal surgery or colorectal cancer.\n2. Patients with previous history of intestinal obstruction or those who are at increased risk of this complication.\n3. Active Clostridium Difficile infection.\n4. Patients on treatment with non-selective beta-blockers for \\\u003C3 month or without stable doses.\n5. Patients on treatment with any immunosuppressive drugs.\n6. Patients on antiviral therapy for HCV or those who have received it within the last 12 months.\n7. Patients on antiviral therapy for HBV therapy for \\\u003C 12 months.\n8. Patients with hepatocellular carcinoma, except for patients with early HCC (BCLC-0 or BCLC-A) or patients with previous history of HCC and absence of recurrence 2 years after treatment.\n9. Patients admitted to the hospital for acute decompensation of the disease. These patients could be included after discharged as long as they do not present any of the following events:\n\n   1. Bacterial infection within 10 days before study inclusion.\n   2. Gastrointestinal bleeding within 10 days before study inclusion.\n   3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the New-Haven classification.\n10. Patients with ACLF according to the criteria published by Moreau et al. (Appendix 1).\n11. Severe alcoholic hepatitis requiring corticosteroid therapy (MELD \\> 20) in the last 6 months.\n12. Patients with active alcohol consumption of more than 21 units per week.\n13. HIV infection.\n14. Patients with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III\u002FIV, COPD GOLD \\>2, chronic kidney disease with serum creatinine \\>2mg\u002FdL or under renal replacement therapy.\n15. Patients with current extra hepatic malignancies including solid tumours and hematologic disorders.\n16. Patients with previous organ transplantation.\n17. Pregnancy or breastfeeding.\n18. Patients included in other clinical trials in the month before inclusion.\n19. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.\n20. Refusal to give informed consent.",{"count":90,"type":21},190,[56],"This is a phase III, multicenter, double-blind, placebo-controlled, randomized clinical trial to evaluate the safety and efficacy of Fecal Microbiota Transplantation (FMT) from healthy subjects to patients with decompensated cirrhosis.",[94],"Decompensated Cirrhosis","2024-07-30",{"date":97,"type":34},"2024-08-01",{"date":99,"type":21},"2024-12",{"date":101,"type":21},"2028-05",{"name":40,"class":41},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100520356","study-of-personalized-allocation-of-defibrillators-in-non-ischemic-heart-failure-spanish-1-100520356","NCT06055504","Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of screening.\n* Previously established diagnosis of Non-ischemic DCM\n* Optimised medical treatment at maximum tolerated doses for at least 3 months prior to the screening date.\n* NYHA functional class II-III.\n* LVEF ≤ 35% documented by CMR as study procedure.\n* Life expectancy greater than 12 months.\n\nExclusion Criteria:\n\n* History of coronary artery disease justifying the presence of ventricular dysfunction, defined as: history of coronary revascularisation or presence of significant coronary stenosis (≥50% in left main or ≥70% in a major epicardial artery) on invasive or non-invasive coronary angiography (coronary CT)\n* Left ventricular dysfunction attributed to congenital heart disease, valvular disease, alcohol abuse or chemotherapy.\n* Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictive pericarditis.\n* History of recovered sudden death or sustained ventricular tachycardia.\n* NYHA functional class IV.\n* Waiting list for cardiac transplantation in emergency 0.\n* Receiver of a solid organ transplant (lung, liver, heart or kidney).",{"count":110,"type":21},900,[24],"Prospective, randomised, multicentre, open-label study to assess the non-inferiority of a personalised precision strategy for Sudden Cardiac Death (SCD) prevention in patients with non-ischemic dilated cardiomyopathy with Left Ventricular Ejection Fraction (LVEF) ≤35%",[114],"Non-ischemic Dilated Cardiomyopathy","2024-02-26",{"date":117,"type":34},"2024-02-28",{"date":119,"type":34},"2023-09-06",{"date":121,"type":21},"2027-10-01",{"name":40,"class":41},31,""]