[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547565":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":31,"studyPopulation":32,"armGroups":33,"interventions":43,"overallOfficials":47,"centralContacts":51,"locations":59,"responsibleParty":86,"collaborators":88,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":27,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":27,"enrollmentInfo":107,"targetDuration":27,"studyType":110,"phases":27,"briefSummary":111,"conditions":112,"keywords":27,"overallStatus":62,"whyStopped":27,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"University of Giessen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":27},[9,13],{"measure":10,"description":11,"timeFrame":12},"Major adverse kidney events","Number of patients experiencing ≥q of the individual outcomes of the composite outcome of eGFR decline ≥25%, initiation of dialysis, or kidney-related death","Baseline to 12 months",{"measure":14,"description":15,"timeFrame":12},"Worsening PH or HF","Number of patients experiencing worsening of PH, defined as hospitalization due to acute right heart failure, increase in PH-targeted medication or diuretics (outpatient or inpatient), or worsening of PH as diagnosed by right heart catheterization",[17,20,24],{"measure":18,"description":19,"timeFrame":12},"All-cause mortality","Number of patients experiencing all-cause mortality during follow-up",{"measure":21,"description":22,"timeFrame":23},"Kidney function decline","Number of patients with 50% decline in eGFR from baseline and the eGFR slope at 12 months","12 months",{"measure":25,"description":26,"timeFrame":23},"Pulmonary hypertension-related death","Death attributed to pulmonary hypertension",null,{"allocation":27,"interventionModel":27,"interventionModelDescription":27,"primaryPurpose":27,"observationalModel":29,"timePerspective":30,"maskingInfo":27},"COHORT","PROSPECTIVE","PH is a severe, progressive disease associated with right ventricular dysfunction, right-sided heart failure (HF) and death. Kidney disease is present in approximately 35% of patients with PH, and its presence is associated with an enhanced risk for adverse outcomes, with the risk increasing incrementally with declining kidney function. Poor right ventricular function may increase venous congestion, alter ventricular interdependence, decrease effective cardiac output and activate the renin-angiotensin- aldosterone system, thereby aggravating kidney disease.\n\nThere is a crucial need to better understand the pathophysiological mechanisms linking the failing right heart and the kidney. To date, diagnostic and prognostic biomarkers of kidney disease in PH are lacking. The objective of this study is to examine the association between urinary and plasma biomarkers and change in eGFR among patients with PH.","Inpatients admitted at University Hospital Giessen and Marburg, Campus Giessen and Kerckhoff Klinik Bad Nauheim with suspected or pre-diagnosed PH undergoing RHC",[34,39],{"label":35,"type":27,"description":36,"interventionNames":37},"Pulmonary hypertension","Patients with diagnosed PH by right heart catheterization with or without PH-specific treatment",[38],"Other: No intervention is planned as part of the study",{"label":40,"type":27,"description":41,"interventionNames":42},"No pulmonary hypertension","Patients in whom PH was excluded by right heart catheterization",[38],[44],{"type":6,"name":45,"description":45,"armGroupLabels":46,"otherNames":27},"No intervention is planned as part of the study",[40,35],[48],{"name":49,"affiliation":5,"role":50},"Faeq Husain-Syed, MD","PRINCIPAL_INVESTIGATOR",[52,56],{"name":49,"role":53,"phone":54,"phoneExt":27,"email":55},"CONTACT","+49 641 985 42378","faeq.husain-syed@innere.med.uni-giessen.de",{"name":57,"role":53,"phone":54,"phoneExt":27,"email":58},"Birgit Jennert, MLA","birgit.jennert@innere.med.uni-giessen.de",[60,73],{"facility":61,"status":62,"city":63,"state":64,"zip":27,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":27},"Kerckhoff Klinik Heart and Thorax Center","RECRUITING","Bad Nauheim","Hesse","Germany","DE",{"type":68,"coordinates":69},"Point",[70,71],8.73859,50.36463,{"lat":71,"lon":70},{"facility":74,"status":62,"city":75,"state":64,"zip":76,"country":65,"countryCode":66,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"University Hospital Giessen and Marburg, Campus Giessen, Department of Internal Medicine II","Giessen","35392",{"type":68,"coordinates":78},[79,80],8.67554,50.58727,{"lat":80,"lon":79},[83,84,85],{"name":49,"role":53,"phone":54,"phoneExt":27,"email":55},{"name":57,"role":53,"phone":54,"phoneExt":27,"email":58},{"name":49,"role":50,"phone":27,"phoneExt":27,"email":27},{"type":87,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[89,91,93,95],{"name":90,"class":6},"Icahn School of Medicine at Mount Sinai",{"name":92,"class":6},"University of Virginia",{"name":94,"class":6},"Kerckhoff Klinik",{"name":96,"class":6},"Universitätsklinikum Hamburg-Eppendorf","100547565","association-between-biomarkers-and-kidney-function-decline-in-pulmonary-hypertension-100547565",false,"NCT06409624","Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension","Association Between Biomarkers and Kidney Function Decline in Patients With Pulmonary Hypertension","Inclusion Criteria:\n\n* Inpatients aged ≥18 years\n* Undergoing right heart catheterization (RHC)\n\nExclusion Criteria:\n\n* multifactorial or indeterminate PH, for which no single underlying mechanism could be reliably classified\n* active tumor disease requiring targeted therapy\n* inflammatory or autoimmune disease with renal involvement requiring systemic immunosuppressive treatment\n* unexplained kidney function decline, defined as serum creatinine increase ≥0.5 mg\u002FdL from baseline within the prior 7 days before RHC\n* Chronic kidney disease with eGFR \\\u003C20 ml\u002Fmin\u002F1.73 m2\n* non-kidney failure requiring extracorporeal or peritoneal ultrafiltration for diuretic-resistant volume overload\n* if they had received non-steroidal anti-inflammatory drugs or intravenous contrast within 72 hours before RHC\n* prediagnosed glomerulonephritis\n* polycystic kidney disease\n* postrenal obstruction\n* single kidney (functional or anatomical)\n* solid organ transplantation\n* anticipated life expectancy of \\\u003C12 months\n* likelihood of receiving advanced therapy (mechanical circulatory assist device\u002Flung or cardiac transplant)\n* pregnancy or possibility of pregnancy in the next 12 months\n* inability to cooperate with respiratory maneuvers during renal Doppler\n* refusal to participate\n* not available for follow-up visits",true,"ALL","18 Years",{"count":108,"type":109},400,"ESTIMATED","OBSERVATIONAL","The objective of this study is to examine the association between urinary and plasma biomarkers and change in estimated glomerular filtration rate (eGFR) among patients with pulmonary hypertension (PH).",[113,114],"Pulmonary Hypertension","Chronic Kidney Disease","2026-09-03",{"date":117,"type":118},"2026-09-08","ACTUAL",{"date":120,"type":118},"2024-05-31",{"date":122,"type":109},"2027-12",{"name":5,"class":6},2]