[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06541509":3,"trial-entities:NCT06541509":175,"trial-summary:NCT06541509":178},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":69,"sex":94,"minimum_age":95,"maximum_age":96,"healthy_volunteers":15,"eligibility_criteria":97,"std_ages":116,"locations":119,"central_contacts":169,"overall_officials":172,"references":173,"see_also_links":174},"NCT06541509","SEMAHEART","Mechanisms of Semaglutide Therapy in Heart Failure Patients","A Pilot Clinical Trial Investigating Underlying Mechanisms of Semaglutide Therapy in Heart Failure Patients","UNKNOWN","2025-09-01","2024-07","2024-08-07","2024-07-10","University Medical Centre Ljubljana","OTHER",false,"Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, primarily used for treatment of type-2 diabetes mellitus. GLP-1 receptors are present on pancreatic islet β-cells, δ-cells and α-cells. Their stimulation increases insulin and somatostatin secretion, and decreases glucagon secretion. In addition, GLP-1 receptor agonists appear to have multiple extrapancreatic actions, which remain poorly defined. In large clinical trials, semaglutide improved the outcomes in obese patients, patients with heart failure with preserved ejection fraction, and decreased the heart failure hospitalizations in patients with type 2 diabetes. The aim of the present study is to investigate the underlying mechanisms of the beneficial clinical effects of semaglutide in the setting of chronic heart failure.",null,[19,20],"Heart Failure","Obesity",[],"INTERVENTIONAL","TREATMENT",[25,26],"PHASE1","PHASE2",{"count":28,"type":29},10,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Semaglutide","10 overweight patients with heart failure will be enrolled, including 5 patients with heart failure with preserved ejection fraction (HFpEF) and 5 patients with heart failure with reduced ejection fraction (HFrEF). The diagnosis of HFpEF and HFrEF will be based on the most recent European Society of Cardiology guidelines for the diagnosis and treatment of heart failure.\n\nAfter their baseline blood sample collections, all participants will receive once-weekly subcutaneous semaglutide (Ozempyc, Novo Nordisk A\u002FS Bagsvaerd, Denmark) at a dose of 0.25 mg for 2 weeks, 0.5 mg for 2 weeks, and then 1.0 mg for a period of 12 weeks. At the end of the 3-month and 4-month period, blood sample collections will be repeated. All blood samples will be sent to Stanford Cardiovascular Institute for further analyses. At baseline, and again at 4 months transthoracic echocardiography, 6-minute walk test, and body composition assessment will be performed.",[36],"Semaglutide Therapy",[38,42,45,47,49,52,54,57,60,63,66],{"measure":39,"description":40,"timeFrame":41},"Interleukin-6 (IL-6)","Measured using enzyme linked immunosorbent assay (ELISA). Units of Measure: picograms per milliliter (pg\u002FmL).","4 months",{"measure":43,"description":44,"timeFrame":41},"Interleukin-8 (IL-8)","Measured using ELISA. Units of Measure: picograms per milliliter (pg\u002FmL).",{"measure":46,"description":44,"timeFrame":41},"Tumor Necrosis Factor-alpha (TNF-α)",{"measure":48,"description":44,"timeFrame":41},"Interferon-gamma (IFN-γ)",{"measure":50,"description":51,"timeFrame":41},"B-type Natriuretic Peptide (BNP)","Measured using immunoassay. Units of Measure: picograms per milliliter (pg\u002FmL).",{"measure":53,"description":51,"timeFrame":41},"C-reactive Protein (CRP)",{"measure":55,"description":56,"timeFrame":41},"Hemoglobin A1C (HgA1C)","Measured using standard laboratory methods. Units of Measure: percent (%).",{"measure":58,"description":59,"timeFrame":41},"Complete Blood Count (CBC)","Measured using automated hematology analyzer. CBC parameters will be measured in their respective units (e.g., cells per microliter).",{"measure":61,"description":62,"timeFrame":41},"Comprehensive Metabolic Panel (Chem 7)","Measured using standard laboratory methods. Chem 7 parameters will be measured in their respective units (e.g., mg\u002FdL, U\u002FL).",{"measure":64,"description":65,"timeFrame":41},"Liver Function Tests (LFT)","Measured using standard laboratory methods. LFT parameters will be measured in their respective units (e.g., mg\u002FdL, U\u002FL).",{"measure":67,"description":68,"timeFrame":41},"Body mass index","Patient weight will be measured in kilograms and height will be measured in meters. Body mass index (BMI) will be calculated according to the standard formula: weight in kilograms divided by height in meters squared.",[70,73,75,78,81,84,86,89,92],{"measure":71,"description":72,"timeFrame":41},"Left ventricular end-systolic volume (LVESV)","Measured using echocardiography. Units of measure: mililiter (mL)",{"measure":74,"description":72,"timeFrame":41},"Left ventricular end-diastolic volume (LVEDV)",{"measure":76,"description":77,"timeFrame":41},"Myocardial mass","Measured using echocardiography. Units of measure: gram (g)",{"measure":79,"description":80,"timeFrame":41},"Left ventricular ejection fraction (LVEF)","Measured using echocardiography. Units of measure: percent (%)",{"measure":82,"description":83,"timeFrame":41},"Left ventricular filling pressures (E\u002Fe')","Measured using echocardiography. Units of measure: numerical value",{"measure":85,"description":80,"timeFrame":41},"Global longitudinal strain (GLS)",{"measure":87,"description":88,"timeFrame":41},"Exercise capacity","Measured by 6-minute walk test distance Units of measure: meter (m)",{"measure":90,"description":91,"timeFrame":41},"Lean body mass","Measured using dual-energy X-ray absorptiometry Units of measure: gram (g)",{"measure":93,"description":91,"timeFrame":41},"Fat mass","ALL","20 Years","80 Years",{"inclusion":98,"exclusion":104,"raw_text":115},[99,100,101,102,103],"Age: 20-80 years","Presence of heart failure","Body-mass index 27 kg\u002Fm2 or greater","Stable optimally tolerated dosages of heart failure therapies for 3 months","N-terminal pro B-type natriuretic peptide levels \\>350 pg\u002FmL",[105,106,107,108,109,110,111,112,113,114],"Presence of type 1 or type 2 diabetes or glycated haemoglobin higher than 6.5%","Pregnancy or potential to become pregnant","Cancer","Liver dysfunction (aspartate aminotransferase and\u002For alanine aminotransferase \\> 3 times upper limits of normal or total bilirubin greater than 1.5 times upper limits of normal)","Renal dysfunction (estimated glomerular filtration rate less than 25 mL\u002Fmin\u002F1.73 m2)","Hospitalization in the past 3 months for reasons other than heart failure","New York Heart Association (NYHA) functional class I or functional class IV symptoms.","Prior or planned bariatric surgery","Self-reported change in body weight \\>11 lbs (5 kg) within 3 months before enrollment","Acute or chronic infection","Inclusion Criteria:\n\n* Age: 20-80 years\n* Presence of heart failure\n* Body-mass index 27 kg\u002Fm2 or greater\n* Stable optimally tolerated dosages of heart failure therapies for 3 months\n* N-terminal pro B-type natriuretic peptide levels \\>350 pg\u002FmL\n\nExclusion Criteria:\n\n* Presence of type 1 or type 2 diabetes or glycated haemoglobin higher than 6.5%\n* Pregnancy or potential to become pregnant\n* Cancer\n* Liver dysfunction (aspartate aminotransferase and\u002For alanine aminotransferase \\> 3 times upper limits of normal or total bilirubin greater than 1.5 times upper limits of normal)\n* Renal dysfunction (estimated glomerular filtration rate less than 25 mL\u002Fmin\u002F1.73 m2)\n* Hospitalization in the past 3 months for reasons other than heart failure\n* New York Heart Association (NYHA) functional class I or functional class IV symptoms.\n* Prior or planned bariatric surgery\n* Self-reported change in body weight \\>11 lbs (5 kg) within 3 months before enrollment\n* Acute or chronic infection",[117,118],"ADULT","OLDER_ADULT",[120,135,147],{"facility":121,"status":122,"city":123,"state":124,"zip":125,"country":126,"contacts":127,"geoPoint":132},"Greenstone Biosciences","RECRUITING","Palo Alto","California","94304","United States",[128],{"name":129,"role":130,"email":131},"Mukhtar Ahmed, PhD","CONTACT","mukhtarahmed@greenstonebio.com",{"lat":133,"lon":134},37.44188,-122.14302,{"facility":136,"status":122,"city":137,"state":124,"zip":138,"country":126,"contacts":139,"geoPoint":144},"Stanford Cardiovascular Institute","Stanford","94305",[140],{"name":141,"role":130,"phone":142,"email":143},"Joseph C Wu, MD, PhD","650-736-2246","joewu@stanford.edu",{"lat":145,"lon":146},37.42411,-122.16608,{"facility":148,"status":122,"city":149,"zip":150,"country":151,"contacts":152,"geoPoint":166},"University Medical Center Ljubljana","Ljubljana","1000","Slovenia",[153,157,161,164],{"name":154,"role":130,"phone":155,"email":156},"Bojan Vrtovec, MD, PhD","+3861 522 1157","bojan.vrtovec@kclj.si",{"name":158,"role":130,"phone":159,"email":160},"Sabina Frljak, MD, PhD","+3861 522 2844","sabina.frljak@kclj.si",{"name":162,"role":163},"Andrej Janez, MD, PhD","SUB_INVESTIGATOR",{"name":165,"role":163},"Mojca Jensterle, MD, PhD",{"lat":167,"lon":168},46.05108,14.50513,[170,171],{"name":154,"role":130,"phone":155,"email":156},{"name":158,"role":130,"phone":159,"email":160},[],[],[],{"nct_id":4,"conditions":176,"biomarkers":177},[19,20],[],{"nct_id":4,"found":179,"summary":180,"prompt_version":190},true,{"design":181,"status":182,"heading":183,"summary":184,"follow_up":185,"word_count":186,"commitments":187,"compensation":188,"drugs_mentioned":189},"This is an interventional study, meaning participants will receive Semaglutide. It will include 10 patients with heart failure and obesity.","completed","Semaglutide for Heart Failure and Obesity","This study is looking at how Semaglutide, a medication often used for type 2 diabetes, works in people with heart failure and obesity. Researchers want to understand its effects beyond what we already know. You might be able to join if you are between 20 and 80 years old, have heart failure and a body-mass index (BMI) of 27 or higher, and are not diabetic. The study will measure specific markers in your blood, like Interleukin-6 (IL-6), Interleukin-8 (IL-8), and Tumor Necrosis Factor-alpha (TNF-α), after 4 months to see how Semaglutide affects them. The study is currently unclear on its recruitment status and plans to enroll 10 patients.","Blood markers will be measured at 4 months after starting the intervention.",108,"Not specified in the trial record.","Not stated in the trial record.",[33],"v2"]