[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tor Biering-Sørensen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":334},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,54,84,114,146,172,202,230,253,281,312],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100630254","phase-4-recombinant-herpes-zoster-vaccine-for-prevention-of-cardiovascular-events-and-dementia-100630254",false,"NCT07485283","Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia","A Pragmatic Randomized Trial to Evaluate the Effect of Recombinant Herpes Zoster Vaccine on Major Adverse Cardiovascular Events and Dementia in Adults Aged 65 Years or Above","DAN-ZOSTER","Inclusion Criteria:\n\n1. Age 65 years and above at the time of consent\n2. Self-reported ability to understand written and spoken Danish or English\n3. Informed consent form has been signed and dated\n\nExclusion Criteria:\n\nThe study has the following exclusion criteria which will be assessed through self-reporting:\n\n1. A prior diagnosis of dementia\n2. Chronic inflammatory rheumatic disease and concomitant immunosuppressive therapy\n3. Prior herpes zoster vaccination",true,"ALL","65 Years",{"count":21,"type":22},162000,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","DAN-ZOSTER is a nationwide randomized study investigating whether vaccination against herpes zoster (shingles) can reduce the risk of cardiovascular disease and dementia in older adults. Herpes zoster is caused by reactivation of the varicella-zoster virus and becomes more common with increasing age. Some observational studies have suggested that vaccination against herpes zoster may also lower the risk of heart attacks, strokes, and dementia, but this has not been confirmed in randomized clinical trials.\n\nIn this study, approximately 162,000 adults aged 65 years or older living in Denmark will be randomly assigned to either receive the recombinant herpes zoster vaccine (Shingrix®) or receive no vaccine. Participants in the vaccine group will receive two doses given 2-6 months apart.\n\nParticipants will be identified and invited using Danish national registries and digital mail systems. Information about health outcomes will be collected through nationwide health registries during follow-up.\n\nThe main outcomes of the study are major cardiovascular events (heart attack, stroke, or cardiovascular death) and new diagnoses of dementia. The goal of the study is to determine whether herpes zoster vaccination can help prevent these conditions in older adults.",[28,29],"Cardiovascular Disease","Dementia",[31,32,33,34,35,36,37,38,39,40,41],"herpes zoster","dementia","myocardial infarction","stroke","cardiovascular death","pragmatic","registry","vaccination","herpes zoster vaccine","shingles","randomized trial","RECRUITING","2026-04-28",{"date":45,"type":46},"2026-05-04","ACTUAL",{"date":43,"type":46},{"date":49,"type":22},"2029-04",{"name":51,"class":52},"Tor Biering-Sørensen","OTHER",2,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":18,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100622345","electronic-letters-to-improve-patient-activation-in-ihd-the-nudge-ihd-trial-100622345","NCT07382414","Electronic Letters to Improve Patient Activation in IHD: The NUDGE-IHD Trial","NUDGE-IHD: A Nationwide Pragmatic Randomized Trial of Electronic Nudges to Increase Patient Activation to Support Risk-factor Control in Ischemic Heart Disease","NUDGE-IHD","Inclusion criteria\n\n* Alive on identification date\n* Diagnosis of IHD defined as either an A or B diagnosis code of I20-I25 in the Danish National Patient Register first registered \\> 6 months prior to identification date\n* Latest available LDL-C is over 1.4 mmol\u002Fl measured up to 3 years prior to the identification date, defined using NPU codes NPU01568, NPU10171 or DNK35308 from the Danish National Laboratory Register\n* Age \\>= 18 years and \\\u003C= 85 on identification date\n\nExclusion criteria\n\n* Nursing home residents\n* Exemption from and thus not access to Digital Post","18 Years","85 Years",{"count":65,"type":22},100000,[67],"NA","The goal of this clinical trial is to learn whether simple electronic information letters can increase patient activation and improve risk-factor monitoring in adults in Denmark with ischemic heart disease (IHD) who have LDL cholesterol above the recommended treatment target. A subgroup of participants with elevated lipoprotein(a) \\[Lp(a)\\] will also be randomized to receive an additional information letter.\n\nThe main questions the study aims to answer are:\n\n* Does sending an electronic letter about elevated LDL cholesterol increase the proportion of patients who have at least one LDL-cholesterol test within 6 months?\n* Among patients with ischemic heart disease and elevated Lp(a), does receiving an information letter about Lp(a) increase patient activation, reflected by cardiometabolic risk-factor monitoring?\n\nBecause this is a randomized trial, researchers will compare people who receive the electronic letter(s) with people who do not receive any letter to determine whether the letters encourage patients to take action, such as obtaining laboratory tests or contacting their doctor.\n\nParticipants will:\n\n* Receive an electronic letter through Denmark's national digital mailbox system (Digital Post) or receive no letter, depending on random assignment.\n* Continue their usual health care, with no additional visits, treatments, or procedures required for the study.\n* Have all study information collected from existing Danish nationwide health registries.",[70,71,72,73],"Coronary Artery Disease","Hypercholesterolemia","Lipoprotein(a)","Secondary Prevention","NOT_YET_RECRUITING","2026-03-08",{"date":77,"type":46},"2026-03-10",{"date":79,"type":22},"2026-04",{"date":81,"type":22},"2026-10",{"name":51,"class":52},1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":18,"minAge":62,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100589263","hemodynamic-effects-of-ketone-esters-in-patients-with-sepsis-induced-cardiomyopathy-100589263","NCT06952140","Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy","KetoSIC","Inclusion Criteria:\n\n* Patients ≥ 18 years of age admitted to the the intensive care unit (ICU)\n* LVEF \\\u003C 50% determined by a screening echocardiography and analysed according to the Simpson biplane method\n* Ability for study personnel to perform transthoracic echocardiography\n* Suspected or documented infection (suspected infection is defined as ongoing antibiotic treatment and\u002For body fluid culture sampling performed within 72 hours before screening)\n\nExclusion Criteria:\n\n* Diagnosis of heart failure with reduced ejection fraction prior to ICU admission according to health records\n* Surgical cause of ICU admission\n* For patients in shock: Other primary causes of shock than sepsis (i.e. hypovolemia, haemorrhage, cardiogenic etiology, pulmonary embolism, anaphylaxis)\n* Blood pH \\\u003C 7.20\n* Severe gastroparesis\n* Inability to position a nasogastric tube",{"count":92,"type":22},12,[67],"Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection and is associated with a high mortality rate in the ICU. Sepsis induced cardiomyopathy (SICM) is a multi-factorial process that appears in approximately 50% of patients with sepsis\u002Fseptic shock and is associated with increased mortality. It is suggested that ketone bodies are more efficient substrates of energy metabolism than glucose, with a lower oxygen consumption per ATP-molecule produced and that the failing human heart increases the capacity to metabolize ketones. Previous studies have found acute beneficial hemodynamic effects of ketone esters in patients with chronic heart failure and cardiogenic shock, respectively. Improved hemodynamics and reduced systemic oxygen consumption as an effect of ketone esters might be of great benefit in patients admitted to the ICU. Thus, the investigators aim to investigate the hemodynamic effects of ketone esters in patients with sepsis induced cardiomyopathy in this randomized, placebo-controlled, double-blinded, cross-over, acute intervention study. .",[96],"Sepsis Induced Cardiomyopathy",[98,99,100,101,102,103,104,105,106],"Sepsis induced cardiomyopathy","Sepsis","Hemodynamics","Ketone ester","Ketones","Echocardiography","Randomized controlled trial","Cross-over trial","Cardiovascular","2026-03-03",{"date":109,"type":46},"2026-03-04",{"date":77,"type":22},{"date":112,"type":22},"2027-12-31",{"name":51,"class":52},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":18,"minAge":62,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":143,"leadSponsor":145,"locationsCount":83},"100569475","phase-3-a-danish-pragmatic-randomized-trial-of-nutritional-supplements-in-heart-failure-100569475","NCT06694727","A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure","A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure (DANUTRIO-HF: Q10, DANUTRIO-HF: Selenium)","DANUTRIO-HF","Inclusion Criteria:\n\n* Individuals aged ≥ 18 years.\n* Registered with a heart failure diagnosis (ICD-10: I50) as a primary discharge diagnosis in The Danish National Patient Registry and at least one claimed prescription of a renin-angiotensin-system inhibitor and a β-blocker within 120 days after HF diagnosis.\n* Informed consent form has been signed and dated.\n\nExclusion Criteria:\n\n* Use of vitamin K-antagonist\n* Registered with a cancer diagnosis (C00-C97 not C44) within the last 5 years excluding cutaneous squamous cell or basal cell carcinoma in The Danish National Patient Registry.",{"count":123,"type":22},4044,[125],"PHASE3","Heart failure is a common and serious condition. Despite rapid advancements in heart failure treatment, the prognosis remains severe. Smaller studies have shown that two simple, safe, and relatively inexpensive nutritional supplements-coenzyme Q10 and selenium-may reduce the risk of complications associated with heart failure. The DANUTRIO-HF trial will investigate whether these supplements can make a difference for individuals with heart failure. The study will assign approximately 4,044 patients from across Denmark to either coenzyme Q10 (100 mg twice daily) or a corresponding placebo, as well as selenium (100 μg twice daily) or its corresponding placebo, and follow how many of them end up being hospitalized for heart failure or dying from heart problems over an estimated two to three-year period.",[128],"Heart Failure",[130,131,132,133,134,103,135,136,137,106,138],"Heart failure","Coenzyme Q10","Selenium","Randomized Controlled Trial","Registry","Pragmatic","Factorial","2x2","Nutritional supplements","2025-09-30",{"date":141,"type":46},"2025-10-03",{"date":139,"type":46},{"date":144,"type":22},"2029-06-01",{"name":51,"class":52},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":18,"minAge":62,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":155,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":83},"100523704","danish-pragmatic-randomized-trial-to-evaluate-the-effect-of-heartlogic-guided-management-on-heart-failure-outcomes-100523704","NCT06099158","Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes","DANLOGIC-HF","Inclusion Criteria:\n\n1. Implanted with a CRT-D or ICD device that has HeartLogic capability and ability to change HeartLogic enablement per randomization\n2. Age ≥18 years\n3. Compliant with remote monitoring and not listed in the LATITUDE™ remote monitoring system as \"not monitored\"\n\nExclusion Criteria:\n\nThere are no specific exclusion criteria for the trial.",{"count":154,"type":22},1428,[67],"The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.",[128],[135,159,160,161,162,134,163],"Heart disease","ICD","CRT-D","Pacemaker","HeartLogic","2025-09-08",{"date":166,"type":46},"2025-09-12",{"date":168,"type":46},"2024-05-31",{"date":170,"type":22},"2027-12-01",{"name":51,"class":52},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":18,"minAge":180,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":83},"100568746","copenhagen-heart-failure-with-preserved-ejection-fraction-100568746","NCT06685237","Copenhagen Heart Failure With Preserved Ejection Fraction","CoPenhagen Heart Failure With Preserved Ejection Fraction (CPH-HFpEF)","CPH-HFpEF","Inclusion Criteria:\n\n1. Residence in the Capital Region of Denmark\n2. Age ≥ 50 years\n3. At least two risk factors for HFpEF defined as any of the following (for age ≥ 60 years, only one):\n\n   * Hypertension\n   * Diabetes mellitus\n   * Chronic kidney disease\n   * Atrial fibrillation\n   * BMI \\> 25 kg\u002Fm2\n   * Previous heart valve surgery\n   * Ischemic heart disease\n   * Obstructive sleep apnea\n   * Furosemide 40 mg\n\nExclusion Criteria:\n\n1. Age ≥ 90 years\n2. Prevalent HF\n3. Dementia\n4. Nursing home\n5. Amyloidosis\n6. Hemodialysis\n7. Cancer diagnosed within the past 5 years (skin cancer not included)\n8. Prior solid organ transplantation\n9. Lung disease defined as any of the following:\n\n   * World Health Organization Group 1 pulmonary hypertension\n   * Chronic pulmonary embolism\n   * Lung fibrosis\n   * Chronic obstructive pulmonary disease (COPD)\n   * Home oxygen","50 Years","89 Years",{"count":183,"type":22},5000,"OBSERVATIONAL","Heart failure with preserved ejection fraction (HFpEF) has grown to become the dominant form of heart failure (HF) worldwide, in tandem with ageing of the general population and the increasing prevalence of obesity, diabetes mellitus and hypertension. In 2020, \\> 70% of patients with heart failure had preserved ejection fraction. The incidence and prevalence of HFpEF has been growing by 10% every 10 years relative to HF with reduced ejection fraction (HFrEF). In 2017, the prevalence of HFpEF varied from 1% to 14% based on available data from Europe and USA. HFpEF is associated with high morbidity and mortality, and patients with HFpEF have similarly high hospitalization rates as patients with HFrEF. Hence, HFpEF poses a substantial global health challenge. Despite its prevalence, HFpEF remains undiagnosed and underrecognized, necessitating a comprehensive approach to both identification and management.\n\nEnsuring successful treatment necessitates early identification of HFpEF. Consequently, a targeted screening strategy has been devised for the identification of HFpEF patients. Given the higher prevalence of heart failure (HF) in the elderly population, testing the screening strategy is imperative to customize it to the specific needs of vulnerable patients who may be more inclined to decline participation in the screening program.",[187],"Heart Failure With Preserved Ejection Fraction (HFPEF)",[189,190,134,191,103,192,193],"Heart failure with preserved ejection fraction","HFpEF","Screening","Questionnaire","NT-proBNP","2025-03-03",{"date":196,"type":46},"2025-03-05",{"date":198,"type":46},"2025-02-28",{"date":200,"type":22},"2026-03-28",{"name":51,"class":52},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":18,"minAge":62,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":217,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":227,"leadSponsor":229,"locationsCount":83},"100581935","phase-4-randomized-comparison-of-morning-versus-bedtime-administration-of-statins-a-cardiovascular-circadian-chronotherapy-c3-trial-100581935","NCT06856772","Randomized Comparison of Morning Versus Bedtime Administration of Statins: A Cardiovascular Circadian Chronotherapy (C3) Trial","STATIN-C3","Inclusion Criteria:\n\n* Age \\>=18 years\n* Current treatment with atorvastatin 10-80 mg, rosuvastatin 5-40 mg, simvastatin 10-80 mg or pravastatin 20-40 mg (as recorded in the Danish National Prescription Registry and confirmed by the participant via questionnaire)\n* Signed informed consent\n\nExclusion Criteria:\n\n* none",{"count":210,"type":22},42000,[25],"Statins inhibit hydroxy-methylglutaryl coenzyme A (HMG-CoA) reductase which catalyzes the rate-limiting step in cholesterol synthesis. This in turn leads to reductions in concentrations of low-density lipoprotein (LDL) cholesterol and C-reactive protein which reduces the risk of incident atherosclerotic events among individuals both with and without a history of atherosclerotic cardiovascular Several pilot studies have suggested potential benefits of taking statin in the evening rather than in the morning.\n\nThe primary objective of this study is to examine whether statin administration at bedtime versus in the morning provides a superior reduction in the incidence of major adverse cardiovascular events among patients with or without established atherosclerotic cardiovascular disease, who are already taking statin.",[214,215,216],"Cardiovascular Diseases (CVD)","Drug Effect","Atherosclerosis Cardiovascular Disease",[218,219,133,135,220,221,222],"Statin","Circadian Rhythm","Outcomes","Cardiovascular disease","Prevention","2025-02-26",{"date":225,"type":46},"2025-03-04",{"date":198,"type":22},{"date":228,"type":22},"2028-03-28",{"name":51,"class":52},{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":18,"minAge":62,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":83},"100466862","phase-2-effects-of-dapagliflozin-on-echocardiographic-measures-of-cardiac-structure-and-function-in-patients-with-ckd-100466862","NCT05359263","Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with CKD","A 6-Month, Randomized, Double-Blind Study to Evaluate the Effect of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease","DECODE-CKD","Inclusion Criteria:\n\n* Signed informed consent\n* ≥ 18 years of age\n* Chronic kidney disease (CKD), defined as evidence of decreased eGFR (eGFR ≥20 and \\\u003C60 mL\u002Fminute per 1.73 m2) or between eGFR ≥60 and \\\u003C90 mL\u002Fminute per 1.73 m2 with urinary albumin:creatinine ratio ≥200 mg\u002Fg or protein:creatinine ratio ≥300 mg\u002Fg\n* Stable treatment with clinically appropriate doses of ACEi\u002FARB among CKD patients with proteinuria and uptitrated to maximal recommended or tolerated dose for at least 4 weeks before randomization, if not medically contraindicated\n* For patients with type 2 diabetes:\n\nStable antihyperglycemic treatment \\> 30 days before screening\n\n* Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device\n* Ability to understand and read Danish\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* For patients with type 2 diabetes:\n\nHistory of diabetic ketoacidosis\n\n* Patients undergoing dialysis\n* History of organ transplant\n* Treatment with SGLT2 inhibitor within 8 weeks prior to enrolment\n* Known allergy or hypersensitivity to SGLT2 inhibitors or Placebo ingredients\n* Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks of enrolment\n* Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair\u002Freplacement within 12 weeks prior to enrolment\n* Any condition outside the renal and cardiovascular study area with a life expectancy of \\\u003C2 years based on investigator's clinical judgement\n* Hepatic impairment (aspartate transaminase or alanine transaminase \\>3 times the upper limit of normal \\[ULN\\] or total bilirubin \\>2 times the ULN at the time of enrolment)\n* Known blood-borne diseases, such as Hepatitis A, B, C, D, and E, and Human immunodeficiency virus (HIV) types 1 and 2, Ebola, Lassa fever virus.\n* Female patients who are pregnant, lactating, or are considering becoming pregnant during the study or for 6 months after study completion\n* Participation in another clinical study with an investigational product within the last month prior to enrolment\n* Inability to understand or comply with the investigational product, procedures, and\u002For follow-up or any conditions that may prevent the participant to complete the study",{"count":239,"type":22},222,[241],"PHASE2","The purpose of this study is to investigate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease.",[244],"Chronic Kidney Diseases","2025-02-06",{"date":247,"type":46},"2025-02-10",{"date":249,"type":46},"2022-06-08",{"date":251,"type":22},"2025-02-18",{"name":51,"class":52},{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":18,"minAge":62,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":263,"conditions":264,"keywords":266,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":83},"100514430","coronary-computed-tomography-angiography-prior-to-catheter-ablation-in-patients-with-atrial-fibrillation-100514430","NCT05978388","Coronary Computed Tomography AngioGraphy Prior to Catheter Ablation in Patients With Atrial FIBrillation","FIBCAG","Inclusion Criteria:\n\n* Age over 18 years.\n* Referral for catheter ablation treatment (excluding AV-junction ablation) for atrial fibrillation (both paroxysmal and persistent atrial fibrillation) at the Department of Cardiology at Gentofte Hospital. Both first ablation and re-ablation treatments are included.\n* The ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Known atherosclerotic cardiovascular disease (ASCVD).\n* Ongoing treatment with statins.\n* Contraindications for coronary CT angiography, e.g. contrast allergy\n* Recent coronary CT angiography including CAC-score without positive findings \\\u003C3 years prior to screening.\n* Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his\u002Fher participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.",{"count":261,"type":22},852,[67],"The purpose of this randomized, controlled trial is to investigate whether coronary computed tomography (CT) angiography prior to catheter ablation and derived treatment (medical anti-ischemic and multimodality treatment and\u002For mechanical revascularization) can improve clinical outcomes in patients with atrial fibrillation undergoing catheter ablation.\n\nA sub-study will investigate the effect of different ablation strategies on clinical outcomes in patients with atrial fibrillation undergoing catheter ablation.",[265],"Atrial Fibrillation",[70,267,265,268,269,270,271,133,272],"Coronary Computed Tomography Angiography","Ischemic heart disease","Catheter Ablation","Atherosclerosis","Cardiovascular Diseases","Statins","2024-06-25",{"date":275,"type":46},"2024-06-26",{"date":277,"type":46},"2024-03-26",{"date":279,"type":22},"2028-04-01",{"name":51,"class":52},{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":18,"minAge":287,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":23,"phases":290,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":83},"100522317","phase-2-the-colchicine-heart-failure-preserved-trial-colheart-preserved-100522317","NCT06081049","The COLchicine HEART Failure PRESERVED Trial (COLHEART-PRESERVED)","Inclusion Criteria:\n\n* LVEF ≥ 45% judged by echocardiography during the screening epoch or within 6 months prior to screening visit\n* Symptom(s) of heart failure for at least 30 days prior to screening visit and current symptoms of heart failure (NYHA functional class II-IV) at screening visit\n* Objective evidence of cardiac structural and\u002For functional abnormalities consistent with the presence of LV diastolic dysfunction\u002Fraised LV filling pressures (left atrial enlargement and\u002For left ventricular hypertrophy) judged by echocardiography at screening epoch or within 12 months prior to screening visit\n* Raised pro-BNP ≥ 125 pg\u002Fml (sinus rhythm) or ≥ 300 pg\u002Fml (atrial fibrillation (AF)).\n* Body Mass Index (BMI) \\\u003C 40 kg\u002Fm2 at screening visit\n* Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device\n* Patients will have given written, informed consent and are able and willing to comply with the requirements of the study protocol\n\nExclusion Criteria:\n\n* Colchicine treatment for another cause, e.g., gout\n* Allergy\u002Fhypersensitivity to colchicine\n* Uncontrolled hypertension (systolic BP \\>180 mmHg or diastolic BP \\>110 mmHg)\n* History of malignancy of any organ system excluding a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, localized prostate cancer and\u002For localized carcinoma in situ of the cervix\n* Cirrhosis, chronic active hepatitis, or other severe hepatic disease\n* Hemodialysis\n* Estimated glomerular filtration rate (eGFR) \\\u003C 35 mL\u002Fmin\u002F1.73 m2\n* Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors\n* Anemia, thrombocytopenia, or leucopenia defined as any of the following measurements within the last 3 months:\n\n  * Hemoglobin \\\u003C 7 mmol\u002FL\n  * Platelet count \\\u003C 110 x 109\u002FL\n  * White blood cell count \\\u003C 3.0 x 109\u002FL\n* Acute decompensated heart failure (hospitalization for heart failure within 7 days prior to screening visit)\n* Acute coronary syndrome (including MI), cardiac surgery, other major cardiovascular surgery, ablation of atrial flutter\u002Ffibrillation, valve repair\u002Freplacement, implanted cardioverter defibrillator or urgent PCI within 3 months prior to screening visit or an elective PCI within 30 days prior to screening visit\n* Planned coronary revascularization (percutaneous intervention or surgical), major cardiac surgery (coronary artery bypass grafting, valve repair\u002Freplacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy), CRT or ablation of atrial flutter\u002Ffibrillation during the trial\n* Any clinical event within 6 months prior to screening visit that could have reduced LVEF (e.g., MI, CABG), unless echocardiographic measurement was performed after the event confirming LVEF ≥ 45%\n* Stroke, transient ischemic attack, carotid surgery, or carotid angioplasty within 3 months prior to screening visit\n* Previous cardiac transplantation, complex congenital heart disease or cardiac resynchronization therapy\n* Heart failure due to any of the following: known infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy, obstructive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy or uncorrected severe\u002Fhemodynamically significant valvular heart disease\n* Life threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and AF or atrial flutter with a resting ventricular rate \\> 110 beats per minute\n* Evidence of right-sided HF in the absence of left sided structural heart disease\n* Probable alternative diagnosis that in the opinion of the investigator could account for the patient's HF symptoms (i.e., anemia, hypothyroidism, severe obesity)\n* World Health Organization Group 1 pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease, including COPD (i.e., requiring home oxygen, chronic nebulizer therapy or chronic oral steroid therapy, or hospitalization for exacerbation of COPD requiring ventilatory assist within 12 months prior to enrollment)\n* Female patients who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion\n* Significant drug or alcohol abuse during the last year\n* Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed)\n* Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea\n* Use of other investigational drugs within 30 days of the time of enrollment\n* Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his\u002Fher participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study\n* Life expectancy \\\u003C 2 years at the screening visit","40 Years",{"count":289,"type":22},152,[241],"The purpose of this study is to investigate the effects of colchicine on heart failure related health status, quality of life, and vascular and cardiac function in patients with heart failure with preserved ejection fraction (HFpEF).",[293],"Heart Failure With Preserved Ejection Fraction",[133,271,295,296,297,103,298,299,300,301,302,303],"Heart Diseases","Colchicine","Inflammation","Hypertrophy, Left Ventricular","Ventricular Function, Left","Diastolic Dysfunction, Left Ventricular","Atrial Enlargement, Left","Quality of Life","Kansas City Cardiomyopathy Questionnaire","2024-02-27",{"date":306,"type":46},"2024-02-28",{"date":308,"type":46},"2024-01-18",{"date":310,"type":22},"2026-06",{"name":51,"class":52},{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":18,"minAge":62,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":23,"phases":321,"briefSummary":322,"conditions":323,"keywords":324,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":83},"100510902","phase-4-randomized-comparison-of-morning-versus-bedtime-administration-of-aspirin-a-cardiovascular-circadian-chronotherapy-c3-trial-100510902","NCT05932472","Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial","ASPIRIN-C3","Inclusion Criteria:\n\n* Age \\>=18 years\n* Current chronic treatment with aspirin (as recorded in the Danish National Prescription Registry and confirmed by the participant via questionnaire)\n* Signed informed consent\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this trial",{"count":320,"type":22},32706,[25],"Wide variability in the antiplatelet effects of aspirin may lead to recurrent thromboembolic events. Several pilot studies have suggested potential benefits of taking aspirin at bedtime rather than in the morning. The primary objective of this study is to examine whether aspirin administration at bedtime versus in the morning provides a superior reduction in the incidence of major adverse cardiovascular events among patients with or without established atherosclerotic cardiovascular disease, who are already taking aspirin.",[270,271,215],[325,28,222,219,133,135,220],"Aspirin","2024-02-05",{"date":328,"type":46},"2024-02-06",{"date":330,"type":46},"2024-01-15",{"date":332,"type":22},"2027-02-15",{"name":51,"class":52},""]