[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-inflammation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-inflammation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,73,100,118,148,181],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100648330","ultrasound-driven-stratification-in-cidp-100648330",false,"NCT07719153","Ultrasound-driven Stratification in CIDP","Ultrasound-driven Stratification in CIDP: A Prospective Observational Study Integrating Imaging and Circulating Biomarkers","TAILOR-CIDP","Inclusion Criteria:\n\n* Male or female aged 18 years or older.\n* Diagnosis of CIDP according to the 2021 EAN\u002FPNS criteria; eligible phenotypes include typical CIDP, asymmetric CIDP (MADSAM\u002FLewis-Sumner syndrome), and pure motor CIDP. Pure sensory CIDP is excluded.\n* Ability to undergo protocol assessments, including clinical evaluation, electrophysiological studies, nerve ultrasound, and blood sampling.\n* Ability to provide written informed consent.\n* Affiliation with a health insurance system or equivalent.\n\nGroup 1-specific criteria:\n\n* Newly diagnosed CIDP.\n* No previous immunomodulatory treatment for CIDP before baseline study assessment.\n* Planned initiation of IVIg according to standard clinical practice.\n\nGroup 2-specific criteria:\n\n* Established CIDP with persistent clinically relevant disability.\n* Documented inadequate, partial, transient, or absent response despite adequate prior therapy, according to the final refractory disease definition.\n* Stable treatment exposure before inclusion according to the final protocol.\n\nExclusion Criteria:\n\n* Pure sensory CIDP.\n* Alternative cause of neuropathy, including hereditary, metabolic, toxic, or other acquired neuropathies judged to better explain the clinical picture.\n* Motor neuron disease, myopathy, neuromuscular junction disorder, or another neurological or neuromuscular condition interfering with clinical, electrophysiological, or ultrasound interpretation.\n* CIDP mimic or alternative diagnosis.\n* Active infection likely to influence study assessments.\n* Active malignancy or other major systemic condition likely to confound biomarker interpretation.\n* Concomitant autoimmune or inflammatory disease likely to materially influence cytokine or complement measurements.\n* Severe psychiatric or cognitive disorder interfering with participation.\n* Participation in another interventional trial when incompatible with the present protocol.\n* Inability or unwillingness to comply with study procedures.","ALL","18 Years","90 Years",{"count":21,"type":22},30,"ESTIMATED","OBSERVATIONAL","Chronic inflammatory demyelinating polyradiculoneuritis (CIDP) is a rare autoimmune neuropathy characterized by significant clinical and therapeutic heterogeneity. Despite the availability of effective treatments, the response to intravenous immunoglobulins remains highly variable, and there are currently no validated biomarkers that can predict this response.\n\nAt the same time, high-resolution nerve ultrasound now makes it possible to identify different morphological profiles that may reflect distinct pathophysiological mechanisms.\n\nThis prospective, observational, single-center study, conducted at the Nice University Hospital, aims to determine whether nerve ultrasound profiles are associated with therapeutic response, clinical severity, and various biomarkers in the blood and cerebrospinal fluid. It includes two predefined cohorts: 20 patients with newly diagnosed PIDC, enrolled before the initiation of immunomodulatory treatment (Group 1), and 10 patients with refractory PIDC and clinically significant disability despite adequate prior treatment (Group 2). The ultimate goal is to develop a stratification strategy that will enable more personalized care for patients with PIDC.",[26,27,28],"CIDP","Chronic Inflammation","Demyelinating Polyneuropathy","NOT_YET_RECRUITING","2026-07-17",{"date":32,"type":33},"2026-07-22","ACTUAL",{"date":35,"type":22},"2026-09-01",{"date":37,"type":22},"2029-09-30",{"name":39,"class":40},"Centre Hospitalier Universitaire de Nice","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100380359","investigating-the-link-between-type-2-immunity-and-nafld-in-human-obesity-100380359","NCT04232566","Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity","Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1","Inclusion Criteria:\n\n* Undergoing gastric bypass surgery\n* Confirmed AUROC F=0 or F\\>2 liver fibrosis\n* Age 30-70 years\n* BMI greater than 40 kg\u002Fm2\n* Negative pregnancy test (female only)\n* Lab Values: Normal TSH\n\nExclusion Criteria:\n\n* Autoimmune diseases\n* Hepatitis B or C positive\n* Heavy alcohol use\n* Active smoking history\n* Active cancer history\n* History of asthma\n* History of COPD\n* Taking Plavix or Coumadin\n* Blood donation within past 2 months\n* Glucocorticoid Therapy\n* Taking antihistamine on regular basis",true,"30 Years","70 Years",{"count":52,"type":22},60,"This study is being done to better understand the relationship between inflammation in adipose tissue (AT), abnormal deposition of fat around the liver and how this affects its appearance and function and ultimately insulin resistance.",[55,56,27],"Obesity, Morbid","NASH - Nonalcoholic Steatohepatitis",[58,59,60,61],"obesity","nash","adipose tissue inflammation","insulin resistance","RECRUITING","2026-01-26",{"date":65,"type":33},"2026-01-28",{"date":67,"type":33},"2022-02-20",{"date":69,"type":22},"2027-12-30",{"name":71,"class":40},"Mayo Clinic",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":72},"100611988","phase-2-the-effect-of-colchicine-on-insulin-sensitivity-in-individuals-with-type-1-diabetes-and-systemic-low-grade-inflammation-100611988","NCT07247734","The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation","The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation: A Randomized, Double-Blind, Placebo-Controlled, Investigator-Initiated Trial","INS1GHT","Inclusion Criteria:\n\n* Type 1 diabetes for more than five years according to World Health Organization criteria and c-peptid \\\u003C200 pmol\u002FL\n* Age 18-80 years\n* User of a continuous glucose monitor (CGM) system\n* Glycated hemoglobin A1c (HbA1c) 42-75 mmol\u002Fmol\n* Stable insulin therapy (defined as no change in insulin brand and no newly initiated Continuous subcutaneous insulin infusion (CSII) or Multiple dose injection (MDI) therapy) and, if applicable, stable usage of glucose monitoring technology (e.g., continuous glucose monitor or intermittently scanned continuous glucose monitor) ≥ 3 months with either multiple daily injections or continuous subcutaneous insulin infusion\n* Estimated glomerular filtration rate ≥ 60 mL\u002Fmin\u002FL\u002F1.73 m²\n* Estimated glucose disposal rate (eGDR)\\* \\\u003C 8 mg\u002Fkg\u002Fmin OR insulin usage of ≥1 IU\u002Fkg pr day\n* C-reactive protein (CRP) hsCRP ≥ 2 mg\u002FL, (measured by high-sensitivity assay)\\*\\*\n\nExclusion Criteria:\n\n* Hypoglycaemia unawareness (inability to register low blood glucose) ad modum Pedersen-Bjergaard, 24 unless the individual uses a continuous glucose monitor with alarm function\n* Liver disease with elevated plasma alanine aminotransferase (ALT) \\> three times the upper limit of normal (measured at screening visit with the possibility of one repeat analysis within seven days, and the last measured value as being conclusive)\n* History of cirrhosis, chronic active hepatitis, or severe hepatic disease\n* Inflammatory bowel disease or chronic diarrhoea\n* Pre-existing progressive neuromuscular disease or individuals with creatinine kinase levels \\> three times the upper limit of normal (measured at screening visit with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)\n* Cancer or lymphoproliferative disease unless in complete remission for \\> 5 years\n* Blood dyscrasias (e.g., myelodysplastic syndromes or related haematological disorders)\n* Leukocyte cell count \\\u003C 3.0 X 109\u002FL\n* Thrombocyte count \\\u003C 110 X 109\u002FL\n* Immunosuppressive therapy or state of chronic immunodeficiency, including infection with human immunodeficiency virus (HIV)\n* Treatment with anti-inflammatory drugs (e.g., non-steroidal anti-inflammatory drugs (NSAID), acetylsalicylic acid (ASA), prednisone) or whole-body topical steroid during the study or within four weeks before study start. Inhaled steroids are allowed. Short term oral NSAID treatment (≤ 3 days) within four weeks before study start or during the study period is allowed. Treatment of ASA is allowed for up to 1000 mg daily.\n* Treatment with colchicine within 60 days of screening visit\n* Known or suspected hypersensitivity to colchicine\n* Treatment with glucose lowering drugs other than insulin (e.g., Glucagon Like Peptide 1 (GLP-1) receptor agonists, metformin, selective sodium glucose cotransporter-2 (SGLT2)-inhibitors) during the study period or within four weeks before study start\n* Haemodialysis or peritoneal dialysis therapy (since colchicine cannot be removed by dialysis or exchange transfusion)\n* Treatment with a P-glycoprotein inhibitor (e.g., azithromycin and verapamil) or a strong CYP3A4 inhibitor (e.g., clarithromycin and ritonavir)\n* Intake of grapefruit juice\n* Other concomitant disease or treatment that according to the investigator's assessment makes the individual unsuitable for study participation\n* Alcohol\u002Fdrug abuse (assessed by the investigator)\n* Regarding fertile women:\n\n  * A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n  * Sterilised or postmenopausal women (no menses for 12 months without an alternative medical cause) can be included without the human chorionic gonadotrophin (hCG)-testing during the trial period\n  * Women who are pregnant, intend to become pregnant, or are breastfeeding will not be included in the study\n  * Female of childbearing potential: must use highly effective contraceptives during the trial and three months after the trial. To exclude pregnancy, urine hCG tests are performed in relation to all visits (V1-V5) and to the phone call in the washout period (P2) and there will be instructions to ensure monthly testing three months after the end of the trial.\n  * The following contraceptive methods are considered highly effective and thus adequate for study enrolment for females if maintained throughout the study duration and three months after the trial: Combined hormonal contraception associated with inhibition of ovulation (containing estrogen and progestogen administered oral, intravaginal or transdermal). Progestogen-only hormonal contraception associated with inhibition of ovulation (admninistered oral, injectable or implantable). Intrauterine device (IUD). Intrauterine hormone-releasing system. Bilateral tubal occlusion. Vasectomised partner. Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject).\n  * Male participants with partners of childbearing potential: must either use a condom or ensure that their partner uses a highly effective contraceptive method during the trial and six months after the trial.\n* Pregnant or nursing women\n* Participants unable to speak or understand Danish\n* Receipt of any investigational drug within 30 days prior to visit 1\n* Simultaneous participation in any other clinical intervention trial","80 Years",{"count":83,"type":22},26,"INTERVENTIONAL",[86],"PHASE2","The aim for this clinical trial is to evaluate if colchicine in addition to standard of care improves insulin sensitivity in individuals with type 1 diabetes, systemic low-grade inflammaiton and reduced insulin sensitivity. The insulin sensitivity will be evaluated by a hyperinsulinemic, euglycemic clamp.",[89,27,90],"Type 1 Diabetes","Insulin Sensitivity","2025-12-22",{"date":93,"type":33},"2025-12-23",{"date":95,"type":33},"2025-12-01",{"date":97,"type":22},"2027-06-22",{"name":99,"class":40},"Asger Lund, MD",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":48,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":72},"100469420","microrna-regulation-of-chronic-inflammation-during-aging-100469420","NCT05392582","MicroRNA Regulation of Chronic Inflammation During Aging","Inclusion Criteria:\n\n1. Age between 18 - 35y; 65y and older\n2. BMI: \\\u003C30 kg\u002Fm2\n3. Ability to sign informed consent\n4. For older participant group: Clinical Frailty Scale score \\\u003C 3 and Mini-Cog score \\> 3\n5. Good general medical health, ambulatory and in independent living setting\n\nExclusion Criteria:\n\n* History of cardiovascular disease (e.g., CHF, CAD, MI, CVA)\n* History of endocrine or metabolic disease such as hypo\u002Fhyperthyroidism and diabetes (Treated hypo\u002Fhyperthyroid for at least 6 months will be permitted)\n* History of kidney disease or failure (CKD \\> stage 4)\n* History of vascular disease\n* Uncontrolled hypertension - Elevated systolic pressure \\>150 or a diastolic blood pressure \\> 100\n* Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma\n* Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for study duration (intra-articular\u002Ftopical\u002Finhaled therapeutic or physiologic doses of corticosteroids will be permitted)\n* Chronic anti-inflammatory medication use (≥ 2 weeks) within 4 weeks of enrollment\n* Chronic inflammatory conditions (e.g., Rheumatoid Arthritis, Crohn's, fibromyalgia, lupus, colitis) HIV, Hepatitis B and C\n* History of stroke with motor disability\n* A recent history (\\\u003C12 months) of GI bleed\n* History of liver disease or AST\u002FALT 2 times above the normal limit\n* History of respiratory disease (acute upper respiratory infection, history of chronic lung disease)\n* Current smokers or current tobacco use\n* Current pregnancy as determined by positive pregnancy test\n* Any staff members who report directly to the principal investigators.",{"count":107,"type":22},40,"This is an observational study enrolling healthy individuals aged 18-35 and 65y and older to determine the health of immune cells in the blood and how these cells create inflammation and effect health as we age. It is hoped that once the nature of this relationship has been discovered we can more effectively design therapies to reduce this inflammation.\n\nThe enrollment goal is 40 participants. The study will occur over the course of 1 month which will include a screening visit and a second visit where the participants will undergo an oral glucose tolerance test, blood draws and leg strength \\& exercise tests.",[27],{"date":111,"type":33},"2025-12-05",{"date":113,"type":33},"2024-11-12",{"date":115,"type":22},"2028-01-01",{"name":117,"class":40},"University of Utah",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":48,"sex":17,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":129,"conditions":130,"keywords":135,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":72},"100544005","pilot-study-of-the-human-metagenome-in-metabolic-diseases-100544005","NCT06363253","Pilot Study of the Human Metagenome in Metabolic Diseases","Understanding the Role of the Human Metagenome in Obesity, Metabolic Diseases, Chronic Inflammation, Sarcopenia and Sarcopenic Obesity - a Pilot Study","Inclusion Criteria (obese cohort):\n\n* Obese (BMI\\>27.5kg\u002Fm2)\n\nInclusion Criteria (sarcopenic cohort):\n\n* Sarcopenic patients, defined as 1) low handgrip strength (\\\u003C26 for males; \\\u003C18kg for females), AND\u002FOR low gait speed (\\\u003C0.8m\u002Fs) AND low muscle mass (\\\u003C7.0kg\u002Fm2 for males; \\\u003C5.7kg\u002Fm2 for females)\n\nInclusion Criteria (control cohort):\n\n\\- Healthy subjects without sarcopenia, and not obese (BMI\\\u003C27.5kg\u002Fm2)\n\nExclusion Criteria:\n\n* No informed consent\n* Presence of intestinal stoma, hence inability to collect fecal samples","21 Years","99 Years",{"count":128,"type":22},600,"This is a cohort study to understand the role of the human metagenome, and associated metabolites, in health and in various diseased states, in particular obesity as well as sarcopenia.\n\nRecruited participants will have their fecal, salivary, urine, serum, and in certain instances, mucosal samples taken, for metagenomic sequencing and metabolite testing.\n\nWe hope to uncover various differences and signatures in the metagenome and metabolome in various diseased states, with potential future therapeutic applications in personalised medicine.",[131,132,133,27,134],"Obesity","Sarcopenia","Sarcopenic Obesity","Metabolic Syndrome",[131,132,136,137,138],"Metabolic syndrome","Metagenomics","Metabolomics","2025-05-12",{"date":141,"type":33},"2025-05-15",{"date":143,"type":33},"2023-08-14",{"date":145,"type":22},"2027-12-31",{"name":147,"class":40},"Sengkang General Hospital",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":84,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":72},"100556257","periodic-fasting-for-treatment-of-long-covid-in-adults-a-pilot-study-100556257","NCT06522750","Periodic Fasting for Treatment of Long Covid in Adults: a Pilot Study","Pilot Study on the Feasibility of an RCT: Evaluating Periodic Fasting as a Treatment Strategy for Long Covid in Adults","FASTCOV-P","Inclusion Criteria:\n\n* Age 18-64\n* Diagnosis Long Covid Syndrome (post-acute COVID-19 symptoms persisting ≥12 weeks)\n* Normal body Mass Index (18.5 to 25 kg\u002Fm2)\n* Marginal Iron status ( PF\\\u003C 25 ng\u002Fml)\n* Able to communicate in and comprehend English and\u002For German and\u002For French language\n* Present written \u002F signed declaration of consent\n* Ability to understand the patient information and willingness to sign the consent form\n* Consent to specimen collection and specimen use\n\nExclusion Criteria:\n\n* Current underweight condition (body mass index less than 18.5 kg\u002Fm2) or weight loss exceeding 3 kg within the last month or 5 kg within the last three months.\n* Existing \u002F current eating disorder within the past five years (e.g., anorexia, bulimia).\n* Psychiatric condition that limits understanding of the examination protocol (unable to consent)\n* Severe internal disease (e.g. kidney deficiency with creatinine \\> 2mg\u002Fdl), chronic inflammatory illness other than LCS\n* Participation in another intervention study.\n* Existing vegan diet or fasting during the last six months\n* Pregnancy or breastfeeding status.\n* Presence or suspicion of pre-existing ME\u002FCFS or early autonomous dysfunction\n* Diagnosis of chronic inflammatory bowel diseases, celiac disease or colorectal cancer according to the guidelines of the German Society of Gastroenterology\n* Use of anti-psychotic drugs\n* Antibiotic use during the previous 12 months\n* Start of novel drug therapy\n* Contraindication for additional blood draws (e.g. hemoglobin \\\u003C10)","64 Years",{"count":158,"type":22},20,[160],"NA","Background:\n\nLong COVID, characterized by persistent symptoms following acute COVID-19 infection, has emerged as a significant public health concern. Symptoms range from fatigue, cognitive impairments, to respiratory difficulties, affecting patients\\' quality of life. Dietary interventions, particularly fasting, have historically been used to modulate immune responses and improve health outcomes in various conditions. The Buchinger-Wilhelmi method represents a structured and medically supervised fasting approach. Given the inflammatory nature of long COVID, fasting may offer therapeutic benefits by modulating the immune response, enhancing cellular repair mechanisms, and resetting metabolic processes.\n\nObjectives:\n\nThis clinical trial aims to assess the feasibility of a 7-day ambulatory fasting intervention using the Buchinger-Wilhelmi method on long COVID patients as primary objective. As secondary objectives, the study will investigate the potential beneficial impact of fasting on clinical, biological, and psychological parameters over a period of 4 weeks, offering insights into potential therapeutic avenues for long COVID management.\n\nStudy timeline:\n\nThe research will span a period of 4 weeks\n\nStudy population:\n\nThis study aims to recruit around 20 participants, who will all receive a fasting intervention using the Buchinger-Wilhelmi method.\n\nBiological sample and data collection:\n\nParticipants will undergo various data and sample collection procedures, including blood draws of up to 90 42 ml per visit, collection of peripheral mononuclear cells, stool samples, and completion of questionnaires in a smartphone-based Application (MyCap).\n\nSample analysis:\n\nThe collected samples will be subjected to a range of analyses, including the assessment of serological markers for routine blood chemistry, evaluation of inflammation markers, and examination of stool samples.",[163,27],"Long Covid",[165,166,167,168,169,170,171],"long covid","fasting","caloric restriction","chronic inflammation","dysbiosis","mitochondrial dysfunction","thrombosis","2025-03-25",{"date":174,"type":33},"2025-03-30",{"date":176,"type":33},"2025-02-19",{"date":178,"type":22},"2025-09-30",{"name":180,"class":40},"University of Luxembourg",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":84,"phases":191,"briefSummary":193,"conditions":194,"keywords":199,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":72},"100562549","phase-4-colchicine-in-patients-with-heart-failure-with-preserved-ejection-fraction-and-inflammation-100562549","NCT06604611","Colchicine in Patients With Heart Failure With Preserved Ejection Fraction and Inflammation","Efficacy and Safety of Colchicine in Patients With Heart Failure With Preserved Ejection Fraction and Inflammation","CHIPS","Inclusion Criteria:\n\n* Left ventricular ejection fraction measured by echocardiography ≥ 50%\n* Objective evidence of structural of functional abnormalities measured by echocardiography: 1)LVMI≥95 g\u002Fm2 in female and ≥115 g\u002Fm2 in male or 2)LAVI greater than 29ml\u002Fm2 in sinus rhythm or greater than 40ml\u002Fm2 in atrial fibrillation or 3)Average E\u002Fe' greater than 14 or 4)TR velocity greater than 2.8 m\u002Fs\n* Patients with elevated NT-proBNP levels 24 hours after discontinuing intravenous diuretics: ≥300 pg\u002Fml in patients with sinus heart rate; ≥600 pg\u002Fml in patients with atrial fibrillation\n* Both outpatient and admitted patients can be considered for enrollment. All patients must occurred worsening heart failure event within 30 days prior to randomization and a current NYHA cardiac function class II-IV\n* Patients with CRP levels greater than 2mg\u002FL\n* Patient agrees to join and signs a written informed consent form\n\nExclusion Criteria:\n\n* Received colchicine treatment within one month prior to randomization\n* Acute coronary syndrome within 3 months prior to randomization, or history of pacemaker implantation, PCI, CABG within 3 months\n* eGFR less than 25 mL\u002Fmin\u002F1.73 m2\n* Liver function Child-Pugh class B or C\n* Patient has a history of previous allergy to colchicine or dapagliflozin \u002F empagliflozin\n* Heart failure due to the following reasons: pericardial disease, pericardial effusion, myocarditis, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and other rare cardiomyopathies such as Fabry disease\n* Combined diagnosis of gastric ulcer, ulcerative colitis, Crohn disease and other digestive disorders or combined gastrointestinal tumors\n* Plan to undergo cardiac surgery such as coronary revascularization, radiofrequency ablation of arrhythmias, valve replacement or other surgical procedures\n* Pregnant or breastfeeding women\n* The patient who is cognitively impaired and is unable to accurately complete the assessment and completion of the KCCQ scale with the assistance of a physician\n* Autoimmune diseases such as systemic lupus erythematosus, long-term adrenocorticotropic hormone treatment for other diseases such as Schihan syndrome, or need to accept immunosuppressive drugs and monoclonal antibodies such as IL-1 and IL-6\n* Patient with combined active solid tumor or hematological malignancy\n* Patient comorbidity with other conditions that may be confused with HFpEF symptoms, such as acute exacerbation of COPD\n* Admission with a well-defined infection (symptoms or pathogenetic evidence of infection, and leukocytes greater than 10\\*109\u002FL)\n* Previously diagnosed with HFrEF (initial assessment of LVEF less than 40%) or diagnosed with LVimpEF",{"count":190,"type":22},200,[192],"PHASE4","The main purpose of the CHIPS trial is to evaluate the efficacy and safety of colchicine in heart failure with preserved ejection fraction (HFpEF) patients with inflammation, including the effects of colchicine on circulating inflammatory markers, cardiac structure, cardiac function, clinical symptoms and exercise capacity in HFpEF patients.",[195,196,27,197,198],"Heart Failure","Heart Failure With Preserved Ejection Fraction (HFPEF)","Inflammation","Colchicine",[195,200,197],"Heart Failure with Preserved Ejection Fraction (HFpEF)","2024-09-17",{"date":203,"type":33},"2024-09-19",{"date":205,"type":22},"2024-10-31",{"date":207,"type":22},"2026-03-31",{"name":209,"class":40},"Dongying Zhang"]