[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657218":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":85,"studyPopulation":76,"armGroups":86,"interventions":97,"overallOfficials":101,"centralContacts":105,"locations":111,"responsibleParty":126,"collaborators":76,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":130,"sex":136,"minAge":137,"maxAge":76,"enrollmentInfo":138,"targetDuration":76,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":156,"whyStopped":76,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Odense University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":76},[9,13],{"measure":10,"description":11,"timeFrame":12},"Long-term outcome: Major Cardiorenal Events","A composite endpoint of time to first occurrence of any of the following:\n\n* Cardiovascular and renal mortality\n* Worsening heart failure (heart failure hospitalisation or an urgent heart failure visit)\n* AMI\n* Stroke\n* End-stage kidney disease (kidney transplantation, maintenance dialysis for ≥28 days, or eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m² confirmed by a second measurement ≥28 days later)\n* A sustained decline in eGFR of ≥50%, confirmed by a second serum creatinine measurements after ≥28 days\n\nMeasured in days.","From baseline to 5 years of follow-up.",{"measure":14,"description":15,"timeFrame":16},"Short-term outcome: Diastolic function","Change in E\u002Fe' (rest) in participants with HFpEF; between-group difference. Absolute value and change from baseline.","From baseline to 1-year follow-up",[18,21,24,28,31,34,38,41,44,47,49,52,55,58,61,64,67,71,73],{"measure":19,"description":20,"timeFrame":16},"Diastolic function (rest and exercise)","Change in E\u002Fe' (rest and exercise) in the overall study population; between-group difference.\n\nAbsolute value and change from baseline.",{"measure":22,"description":23,"timeFrame":16},"Neurohormonal activation","NT-proBNP. Change from baseline to 1-year follow-up. pg\u002FmL",{"measure":25,"description":26,"timeFrame":27},"HFpEF classification and prevalence","Prevalence of HFpEF and comparison of diagnostic algorithms. Prevalence and change in classification from baseline to 1-year follow-up.","From baseline to 1-year follow-up.",{"measure":29,"description":30,"timeFrame":16},"Albuminuria","Change in UACR from baseline to 1-year follow-up; between-group difference. mg\u002Fg",{"measure":32,"description":33,"timeFrame":16},"eGFR slope (creatinine based)","Change in eGFR slope (total and chronic); between-group difference. mL\u002Fmin\u002F1.73 m2",{"measure":35,"description":36,"timeFrame":37},"Cystatin C","Prognostic value of cystatin C with respect to the risk of HFpEF and its association with NYHA classification.","Evaluated at the baseline and 1-year follow-up visit",{"measure":39,"description":40,"timeFrame":27},"Symptom burden (HF-related)","Change in NYHA functional class from baseline to 1-year follow-up; between-group difference.",{"measure":42,"description":43,"timeFrame":16},"Symptom burden (CKD-related)","Change in uremic symptom burden from baseline to 1-year follow-up; between-group difference.",{"measure":45,"description":46,"timeFrame":16},"Physical performance","Change in 6-minute walk test from baseline to 1-year follow-up; between-group difference. In meters walked.",{"measure":45,"description":48,"timeFrame":16},"Change in 1-minute sit-to-stand test from baseline to 1-year follow-up; between-group difference. Number of repetitions.",{"measure":50,"description":51,"timeFrame":16},"Disease-specific health status","Change in KCCQ-12 score from baseline to 1-year follow-up; between-group difference",{"measure":53,"description":54,"timeFrame":16},"Health-related quality of life","Change in EQ-5D-5L score from baseline to 1-year follow-up; between-group difference",{"measure":56,"description":57,"timeFrame":27},"Cardiovascular risk","Change in prediction of cardiovascular events according to the established ESC scoring systems from baseline to 1-year follow-up; between-group difference.",{"measure":59,"description":60,"timeFrame":27},"Renal risk","Change in predicted risk of progression to end-stage kidney disease according to the Kidney Failure Risk Equation from baseline to 1-year follow-up; between-group difference.",{"measure":62,"description":63,"timeFrame":12},"Long-term cardiovascular outcomes (five years)","Time to first occurrence of any of the individual components:\n\n* CV mortality\n* HF worsening (hospitalisation or urgent outpatient visit)\n* AMI\n* Stroke Between-group difference. Measured in days.",{"measure":65,"description":66,"timeFrame":12},"Long-term kidney outcomes (five years)","Time to first occurrence of any of the individual components:\n\n* Renal mortality\n* End-stage kidney disease (kidney transplantation, maintenance dialysis for ≥28 days, or eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m² confirmed by a second measurement ≥28 days later)\n* A sustained decline in eGFR of ≥50%, confirmed by a second serum creatinine measurements after ≥28 days.\n\nMeasured in days.",{"measure":68,"description":69,"timeFrame":70},"Composite long-term cardiorenal outcome (ten years)","A composite endpoint of time to first occurrence of any of the following:\n\n* Cardiovascular and renal mortality\n* Worsening heart failure (heart failure hospitalisation or an urgent heart failure visit)\n* AMI\n* Stroke\n* End-stage kidney disease (kidney transplantation, maintenance dialysis for ≥28 days, or eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m² confirmed by a second measurement ≥28 days later)\n* A sustained decline in eGFR of ≥50%, confirmed by a second serum creatinine measurements after ≥28 days.\n\nMeasured in days.","From baseline to 10 years of follow-up.",{"measure":72,"description":63,"timeFrame":70},"Long-term cardiovascular outcomes (ten years)",{"measure":74,"description":75,"timeFrame":70},"Long-term kidney outcomes (ten years)","Time to first occurrence of any of the individual components:\n\n* Renal mortality\n* End-stage kidney disease (kidney transplantation, maintenance dialysis for ≥28 days, or eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m² confirmed by a second measurement ≥28 days later)\n* A sustained decline in eGFR of ≥50%, confirmed by a second serum creatinine measurements after ≥28 days.\n\nMeasured ind days.",null,{"allocation":78,"interventionModel":79,"interventionModelDescription":76,"primaryPurpose":80,"observationalModel":76,"timePerspective":76,"maskingInfo":81},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":82,"maskingDescription":76,"whoMasked":83},"SINGLE",[84],"OUTCOMES_ASSESSOR","Background Cardiovascular disease (CVD) and chronic kidney disease (CKD) frequently coexist and together constitute a major global health burden associated with substantially increased morbidity, mortality, and healthcare utilisation. Importantly, the coexistence of CVD and CKD predisposes patients to heart failure with preserved ejection fraction (HFpEF), a complex clinical syndrome characterised by a high symptom burden, impaired quality of life, and a poor prognosis. HFpEF accounts for approximately half of all heart failure cases and may further aggravate the progressive interaction between cardiovascular and renal dysfunction.\n\nOver the past decade, major therapeutic advances have improved outcomes in patients with CVD, CKD, and HFpEF. Large randomised trials, including DELIVER and EMPEROR-Preserved, have demonstrated that sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors) improve clinical outcomes in patients with HFpEF. Renin-angiotensin system inhibitors and SGLT2 inhibitors also reduce adverse outcomes in patients with CKD. Furthermore, emerging evidence supports the use of non-steroidal mineralocorticoid receptor antagonists in patients with HFpEF or CKD.\n\nDespite this strong evidence base, the implementation of guideline-directed treatment remains suboptimal. In a pilot study conducted at our centre, only one-third of patients with coexisting CVD and CKD received fully optimised CKD treatment, consistent with findings from similar studies. Consequently, the principal challenge is no longer solely the development of effective therapies, but also the systematic implementation of existing evidence-based treatments in patients with complex multimorbidity.\n\nCurrent care models are predominantly fragmentated, with cardiology, nephrology, and primary care operating independently. This fragmentation leads to suboptimal coordination, delayed treatment optimisation, and inconsistent application of guidelines.\n\nThe OPTICARE Trial addresses this gap by evaluating a structured, multidisciplinary cardiorenal care model designed to optimise treatment in accordance with current clinical guidelines. We hypothesise that this model will significantly improve cardiovascular and renal outcomes compared with standard care and has the potential to transform clinical pathways and future guideline recommendations.\n\nPurpose and hypothesis The aim of this randomised trial is to evaluate the effectiveness of a systematic, specialised, multidisciplinary cardiorenal intervention, delivered through a Cardio-Renal Clinic, in improving cardiovascular and renal outcomes, reducing mortality and symptom burden, and improving quality of life and physical performance in patients with CVD and CKD.\n\nThe project consists of two studies. Study One will evaluate the short-term effects of multidisciplinary cardiorenal care after one year. Study Two will evaluate its long-term effects after five and ten years.\n\nWe hypothesise that a specialised, multidisciplinary Cardio-Renal Clinic delivering guideline-directed cardiorenal care will improve both cardiovascular, renal, functional, and patient-reported outcomes compared with standard care.\n\nMethods The OPTICARE Trial is a single-centre, randomised, controlled, open-label, parallel-group trial including 500 participants with coexisting CVD and CKD.\n\nAt baseline, participants will undergo a comprehensive assessment comprising:\n\n* Current clinical status and symptoms\n* Cardiovascular and renal medical history\n* Family history of cardiovascular and kidney disease\n* Current medical treatment\n* Lifestyle factors\n* Patient-reported outcomes, including the KCCQ-12 and EQ-5D-5L questionnaires\n\nClinical examinations and investigations at baseline will include:\n\n* Echocardiographic assessment of cardiac structure and function at rest and during exercise\n* Assessment of volume status\n* Blood pressure measurement\n* Anthropometric measurements, including height, weight, body mass index, waist-to-hip ratio, and waist-to-height ratio\n* Assessment of physical function using the 6-minute walk test and the 1-minute sit-to-stand test\n* Blood and urine tests to assess cardiovascular and renal biomarkers\n* A standard 12-lead electrocardiogram\n* Estimation of cardiovascular and renal risk Participants will be randomised in a 2:1 ratio to either multidisciplinary care in the Cardio-Renal Clinic or standard care.\n\nParticipants assigned to the Cardio-Renal Clinic will undergo systematic assessment and optimisation of their treatment. The treatment algorithm will be based on current national and international clinical guidelines for the management of CKD, HFpEF, hypertension, dyslipidaemia, and thromboembolic risk. Additionally, participants will receive counselling on diet, physical activity, smoking cessation, alcohol consumption, weight management, and recommended vaccinations.\n\nAll treatment decisions will be based on current national and international clinical guidelines and established evidence-based practice. Treatment decisions will be supported by a decision-support algorithm integrated into REDCap. The algorithm will be updated when relevant guideline recommendations change.\n\nFollowing treatment initiation or adjustment, clinical and biochemical follow-up will be arranged as clinically indicated and in accordance with current guideline recommendations.\n\nParticipants assigned to standard care will continue their existing treatment without any intervention by the study team. They will be encouraged to continue their prescribed medications and attend planned appointments with their general practitioner and relevant outpatient clinics.\n\nA comprehensive follow-up visit will be conducted one year after randomisation to evaluate the short-term effects of the intervention. The principal baseline examinations and assessments will be repeated at this visit.\n\nAfter five and ten years, medical records will be reviewed to identify major cardiovascular and renal events. The five and ten-year follow-up will contribute to assess the long-term effect of the specialised, multidisciplinary treatment provided in the Cardio-Renal Clinic.\n\nSample size estimation The sample size calculation is based on the long-term primary composite cardiorenal endpoint. This endpoint resembles the composite kidney and cardiovascular outcome evaluated in the DAPA-CKD trial. Among participants without diabetes in DAPA-CKD, a hazard ratio of approximately 0.50 was reported.\n\nAssuming a two-sided significance level of 0.05, a statistical power of 80%, and a 2:1 allocation ratio, a total of 74 primary endpoint events are required to detect the anticipated treatment effect. Assuming an annual event rate of 6% in the control group and a planned follow-up period of five years, 464 participants are estimated to provide the required number of events. To account for withdrawal and loss to follow-up, a total of 500 participants will be included.\n\nExpected contribution This research project aims to improve the care of a high-risk patient population whose treatment needs may not be adequately addressed within existing, specialty-specific models of care. By strengthening early detection, multidisciplinary collaboration, and the implementation of guideline-directed treatment, the project has the potential to improve both short- and long-term patient outcomes.\n\nBeyond the potential benefits to study participants, the project may contribute to the development of integrated care models within the public healthcare system. The Cardio-Renal Clinic is intended to provide a scalable and resource-efficient model that could improve continuity of care, reduce fragmentation between medical specialties, and support more individualised, evidence-based treatment pathways. If successful, the project may serve as a framework for future cardio-renal clinics in Denmark and internationally.",[87,93],{"label":88,"type":89,"description":90,"interventionNames":91},"Multidisciplinary Cardio-Renal Care","ACTIVE_COMPARATOR","Compromising a multidisciplinary, structured, and specialised optimisation of cardiovascular and renal therapy, including lifestyle interventions, according to contemporary guidelines.",[92],"Other: Multidisciplinary Cardio-Renal Care",{"label":94,"type":95,"description":96,"interventionNames":76},"The Standard Care Group","NO_INTERVENTION","Participants will continue their current medical treatment without intervention from the study team. They will be encouraged to continue taking their prescribed medications and attend scheduled appointments with their general practitioner and relevant outpatient clinics.",[98],{"type":6,"name":88,"description":99,"armGroupLabels":100,"otherNames":76},"A structured, multidisciplinary intervention comprising guideline-directed assessment and optimisation of cardiovascular and renal treatment, based on latest guideline recommandations from ESC and KDIGO. The intervention include treatment of:\n\n* Heart failure\n* Blood pressure management\n* Thrombosis prophylaxis\n* Dyslipidaemia management\n* Kidney protectective therapies\n* Treatment of kidney failure complications\n* Counseling on lifestyle factors, including diet, alcohol consumption, smoking, physical activity, weight management, and sleep apnea.",[88],[102],{"name":103,"affiliation":5,"role":104},"Søren Auscher, MD, PhD, Associated Professor","PRINCIPAL_INVESTIGATOR",[106],{"name":107,"role":108,"phone":109,"phoneExt":76,"email":110},"Eline Panadevo, MD","CONTACT","+45 63 20 24 02","eline.panadevo@rsyd.dk",[112],{"facility":113,"status":76,"city":114,"state":76,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"Cardiovascular Research Unit, Odense University Hospital Svendborg","Svendborg","5700","Denmark","DK",{"type":119,"coordinates":120},"Point",[121,122],10.60677,55.05982,{"lat":122,"lon":121},[125],{"name":107,"role":108,"phone":109,"phoneExt":76,"email":110},{"type":127,"investigatorFullName":76,"investigatorTitle":76,"investigatorAffiliation":76,"oldNameTitle":76,"oldOrganization":76},"SPONSOR","100657218","optimised-cardiovascular-and-renal-protection-in-patients-with-chronic-kidney-disease-and-cardiovascular-disease-100657218",false,"NCT07835828","Optimised Cardiovascular and Renal Protection in Patients With Chronic Kidney Disease and Cardiovascular Disease","Optimised Multidisciplinary Cardiovascular and Renal Protection in Patients With Chronic Kidney Disease and Cardiovascular Disease: Effects on Diastolic Function, Cardiovascular and Renal Outcomes","OPTICARE","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Capable of giving written informed consent\n* Established chronic kidney disease, and at least two measurements of: 1) eGFR \\\u003C45 and \\>15 mL\u002Fmin\u002F1.73 m², and\u002For 2) UACR \\>200 mg\u002Fg, or 3) eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m² and UACR \\>30 mg\u002Fg.\n* Established cardiovascular disease, including prior acute coronary syndrome, chronic coronary syndrome, objective evidence of myocardial ischaemia, non-coronary atherosclerotic cardiovascular diase (stroke or peripheral arterial disease), heart failure with preserved ejection fraction, atrial fibrillation and\u002For flutter, clinically significant valvular disease, or hypertension treated with three or more antihypertensive drugs.\n\nExclusion Criteria:\n\n* Established heart failure with reduced ejection fraction.\n* Diabetes type I or II\n* Patients receiving chronic dialysis or having of kidney transplant.\n* Expected life expectancy \\\u003C5 years.\n* Inability to understand the study procedures, comply with study requirements, or presence of any condition that, in the opinion of the research staff, may interfere with the patient's ability to participate in or complete the study.\n* Participation in another clinical trial with an investigational product or device that could interfere with the primary and\u002For secondary endpoints of this study.","ALL","18 Years",{"count":139,"type":140},500,"ESTIMATED","INTERVENTIONAL",[143],"NA","The goal of this clinical trial is to investigate whether care in a specialised Cardio-Renal Clinic can improve the health of people living with both cardiovascular disease and chronic kidney disease. The clinic brings together expertise in heart and kidney disease and provides structured treatment based on current clinical guidelines.\n\nThe main research questions are:\n\n* After one year, does care in the Cardio-Renal Clinic improve measures of heart and kidney function, quality of life, symptoms, and physical ability compared with usual care?\n* After five years, does care in the Cardio-Renal Clinic reduce the risk of death, hospitalisation for heart failure, heart attack, stroke, worsening kidney function, or kidney failure compared with usual care? At the beginning of the study, all participants will undergo a detailed assessment of their heart and kidney health. This will include blood and urine tests, an ultrasound examination of the heart, questionnaires, and tests of physical ability.\n\nParticipants will then be randomly assigned to either optimised care in the Cardio-Renal Clinic or usual care.\n\nParticipants assigned to the Cardio-Renal Clinic will have their treatment reviewed and adjusted by a multidisciplinary team. The clinic may recommend or prescribe approved medications that are already used in routine care for heart and kidney disease. No experimental medications will be used.\n\nParticipants assigned to usual care will continue to receive care from their general practitioner and any hospital departments involved in their treatment.",[146,147,148],"Chronic Kidney Disease","Heart Failure With Preserved Ejection Fraction (HFPEF)","Cardiovascular Diseases",[150,146,151,152,153,154,155],"Cardiorenal Syndrome","Heart Failure With Preserved Ejection Fraction","Diastolic Dysfunction","Multidisciplinary Care","Guideline-Directed Medical Therapy","Treatment Optimisation","NOT_YET_RECRUITING","2026-09-17",{"date":159,"type":160},"2026-09-23","ACTUAL",{"date":162,"type":140},"2026-10-01",{"date":164,"type":140},"2038-10-01",{"name":5,"class":6},1]