[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure-and-impaired-kidney-function\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure-and-impaired-kidney-function":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100539731","phase-3-study-to-evaluate-the-effect-of-balcinrenonedapagliflozin-in-patients-with-heart-failure-and-impaired-kidney-function-100539731",false,"NCT06307652","Study to Evaluate the Effect of Balcinrenone\u002FDapagliflozin in Patients With Heart Failure and Impaired Kidney Function","A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone\u002FDapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function","BalanceD-HF","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Documented diagnosis of symptomatic HF (NYHA functional class II-IV)\n* Having had a recent HF event within 6 months (hospitalization or urgent visit)\n* Have a LVEF value from an assessment within the last 12 months\n* Managed with SoC therapy for HF and renal impairment according to local guidelines\n* NT-proBNP must be \\>300 pg\u002FmL (\\>600 pg\u002FmL if concomitant atrial fibrillation or atrial flutter)\n* Not taking an MRA\n* An eGFR ≥ 20 to \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n* Serum\u002Fplasma potassium ≤ 5.0 mmol\u002FL\n\nExclusion Criteria:\n\n* Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period\n* Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations\n* History of hypertrophic obstructive cardiomyopathy\n* Complex congenital heart disease or severe uncorrected primary valvular disease\n* Symptomatic bradycardia or second- or third-degree heart block without a pacemaker\n* Systolic BP \\\u003C 90 mmHg, or symptomatic hypotension within the past 24 hours\n* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment\n* Type 1 diabetes mellitus\n* Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy\n* Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy\n* Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks\n* Treatment with strong or moderate CYP3A4 inhibitor or inducer","ALL","18 Years","130 Years",{"count":21,"type":22},3850,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone\u002Fdapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.",[28],"Heart Failure and Impaired Kidney Function","RECRUITING","2026-09-09",{"date":32,"type":33},"2026-09-11","ACTUAL",{"date":35,"type":33},"2024-04-12",{"date":37,"type":22},"2027-04-16",{"name":39,"class":40},"AstraZeneca","INDUSTRY",852]