[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588331":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":38,"responsibleParty":66,"collaborators":69,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":25,"enrollmentInfo":87,"targetDuration":25,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Endocalyx Pro","EXPERIMENTAL","Endocalyx is a food supplement that is distributed by Microvascular Health Solutions LLC in Chattanooga, Tennessee. Patients will receive 4 capsules Endocalyx per day, for 12 consecutive weeks. The capsules are orally administered and can be taken with water, on an empty stomach or with food. If possible, the patient will take 2 capsules in the morning, and 2 capsules in the afternoon. If preferred by the patient, the 4 capsules could also be taken once daily in the morning.",[13],"Dietary Supplement: Endocalyx Pro",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo pills will be provided by Microvascular Health Solutions and are matched with the Endocalyx capsules. The placebo capsules contain no active pharmaceutical ingredients and contain solely widely used excipients. Patients will receive 4 capsules of the placebo per day for 12 consecutive weeks. The capsules are orally administered and can be taken with water, on an empty stomach or with food. If possible, the patient will take 2 capsules in the morning, and 2 capsules in the afternoon. If preferred by the patient, the 4 capsules could also be taken once daily in the morning.",[19],"Other: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","4 capsules once daily OR 2 capsules twice daily",[9],null,{"type":6,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Rik Olde Engberink, MD PhD","CONTACT","0031205661930","r.h.oldeengberink@amsterdamumc.nl",{"name":35,"role":31,"phone":36,"phoneExt":25,"email":37},"Sanédy Simon, MD","0031205667789","s.s.a.simon@amsterdamumc.nl",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Amsterdam UMC","RECRUITING","Amsterdam","North Holland","1105 AZ","Netherlands","NL",{"type":48,"coordinates":49},"Point",[50,51],4.88969,52.37403,{"lat":51,"lon":50},[54,56,58,61,63],{"name":30,"role":31,"phone":55,"phoneExt":25,"email":33},"+31(0)205661930",{"name":35,"role":31,"phone":57,"phoneExt":25,"email":37},"+31(0)20567789",{"name":59,"role":60,"phone":25,"phoneExt":25,"email":25},"C.L. Zwager, MD","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":25,"phoneExt":25,"email":25},"S.S.A Simon, MD",{"name":64,"role":65,"phone":25,"phoneExt":25,"email":25},"R.H.G Olde Engberink, Nephrologist","PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Rik Olde Engberink","Principal investigator",[70,72,74],{"name":71,"class":6},"Dutch Heart Foundation",{"name":73,"class":6},"Dutch Kidney Foundation",{"name":75,"class":76},"Microvascular Health Solutions LLC","UNKNOWN","100588331","phase-2-endocalyx-in-treatment-resistent-hypertension-100588331",false,"NCT06940011","Endocalyx in Treatment Resistent Hypertension","Glycocalyx Restoration in Treatment Resistant Hypertension: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study","GLYCO-TRH","Inclusion Criteria:\n\n1. Treatment resistant hypertension defined as\n\n   1. an uncontrolled office BP (≥140\u002F90 mmHg).\n   2. is on a regimen of ≥3 adequately dosed antihypertensive agents of different classes, including a diuretic, at maximum tolerated dose based on investigator judgment.\n2. Stable diuretic and antihypertensive treatment for the previous 3 weeks.\n3. Subject, or legal representative, has voluntarily signed and dated an Informed Consent Form, approved by the Independent Ethics Committee (IEC).\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years.\n2. Estimated glomerular filtration rate (eGFR) \\\u003C20 ml\u002Fmin\u002F1.73m2 measured by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula and the 2012 cystatin C CKD-EPI formula.\n3. A mean seated systolic blood pressure of at least 180 mmHg or a diastolic blood pressure of at least 110 mmHg.\n4. Known secondary hypertension\n5. An acute coronary syndrome, stroke, transient ischemic attack or cardiovascular surgery in the last 3 months.\n6. Hospitalization for heart failure in the past 3 weeks.\n7. Dialysis treatment or expected initiation of dialysis within 3 months of screening.\n8. Women of child bearing potential who are not taking adequate contraception (i.e. \\\u003C1% failure rate).\n9. Planned surgery in the next 12 weeks\n10. Major surgery in the previous 4 weeks.\n11. Use of prednisolone \\>5 mg\u002Fday\n12. Use of any other investigational drug.\n13. Presence of significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year.\n14. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.\n15. Known hypersensitivity to seaweed, corn, artichoke, grape, melon or to any of the excipients of Endocalyx.\n16. Known hypersensitivity or allergies for milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans.\n17. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption.","ALL","18 Years",{"count":88,"type":89},64,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","The goal of this randomized, double-blind, placebo-controlled study is to assess whether the food supplement Endocalyx lowers blood pressure in patients with treatment resistant hypertension.",[95],"Treatment Resistant Hypertension",[97,98,99,100],"Glycocalyx","Glycosaminoglycans","non-osmotic sodium storage","hypertension","2025-04-15",{"date":103,"type":104},"2025-04-23","ACTUAL",{"date":106,"type":104},"2025-01-21",{"date":108,"type":89},"2028-01-01",{"name":5,"class":6},1]