[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595211":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":59,"collaborators":30,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":30,"enrollmentInfo":72,"targetDuration":30,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":38,"whyStopped":30,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-arm","EXPERIMENTAL","Eplerenone",[13],"Drug: Eplerenone",[15],{"type":16,"name":11,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Participants will receive eplerenone 25 mg once daily or every other day, based on baseline potassium levels, eGFR, systolic blood pressure, and concomitant use of weak or moderate CYP3A4 inhibitors.\n\nThe study will implement a safety protocol with predefined procedures for managing significant hyperkalemia, worsening renal function, and hypotension. These will include temporary or permanent dose reduction or discontinuation of eplerenone, and, if necessary, administration of the potassium binder sodium zirconium cyclosilicate (SZC, Lokelma®).",[9],[20],"Inspra®",[22],{"name":23,"affiliation":5,"role":24},"Krister Lindmark, MD, PhD","STUDY_DIRECTOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Carl Haggård, MD, PhD","CONTACT","0046735574724",null,"carl.haggard@regionstockholm.se",{"name":23,"role":28,"phone":33,"phoneExt":30,"email":34},"00467028888285","krister.lindmark@regionstockholm.se",[36],{"facility":37,"status":38,"city":39,"state":30,"zip":30,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Department of Cardiology, Danderyd Hospital, Karolinska Institutet","RECRUITING","Stockholm","Sweden","SE",{"type":43,"coordinates":44},"Point",[45,46],18.06871,59.32938,{"lat":46,"lon":45},[49,50,51,53,54,57],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":23,"role":28,"phone":33,"phoneExt":30,"email":34},{"name":27,"role":52,"phone":30,"phoneExt":30,"email":30},"PRINCIPAL_INVESTIGATOR",{"name":23,"role":52,"phone":30,"phoneExt":30,"email":30},{"name":55,"role":56,"phone":30,"phoneExt":30,"email":30},"Karl Wärnberg, MD","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":30,"phoneExt":30,"email":30},"Karin Bergen, MD, PhD",{"type":52,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Carl Haggård","MD, PhD","100595211","phase-2-swedish-cardiac-and-renal-failure-study-1-100595211",false,"NCT07029503","Swedish Cardiac And Renal Failure Study-1","Swedish Cardiac And Renal Failure Study-1 (SCARF-1): An Open-Label Pilot Trial to Evaluate the Feasibility, Safety and Efficacy of Eplerenone in Patients With Heart Failure With Reduced Ejection Fraction and Severe Chronic Kidney Disease","SCARF-1","Inclusion Criteria:\n\n* The participant has given their written consent to participate\n* A diagnosis of HFrEF according to current criteria, for at least three months before the screening visit\n* Echocardiography within 24 months of the screening visit with ejection fraction ≤ 40%. The responsible investigator is allowed to order a new TTE at their own discretion if clinically indicated - e.g. following the initiation of markedly intensified HFrEF-treatment or in the event of significant clinical deterioration. If the new TTE shows an EF \\> 40%, the participant will not be eligible for inclusion. However, a potential echocardiographic worsening should not, by itself, preclude enrollment\n* New York Heart Association class II-III\n* Optimally treated and stable HFrEF (according to the investigator) since at least four weeks before the screening visit. Treatment should include beta-blockers, sodium\u002Fglucose co-transporter 2 inhibitors, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers if eGFR ≥ 20 ml\u002Fmin\u002F1.73m2 according to the revised Lund-Malmö method. Participants should also have cardiac resynchronization therapy or an implantable cardioverter-defibrillator if the indication exists according to current guidelines\n* eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m2 according to the revised Lund-Malmö method at least once during the 12 months before the screening visit, and eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m2 at the time of inclusion\n\nExclusion Criteria:\n\n* P-K ≥ 5.6\n* For the first ten study participants:\n\neGFR \\\u003C 20 ml\u002Fmin\u002F1.73m2 according to the revised Lund-Malmö method, or projected decline in eGFR to \\\u003C 10 ml\u002Fmin\u002F1.73m2 during the 36-week study period. The projected decline will be estimated using the three most recent eGFR values from the previous 6-12 months\n\n\\- For the remainder of the study participants: eGFR \\\u003C 10 ml\u002Fmin\u002F1.73m2 according to the revised Lund-Malmö method, or projected decline in eGFR to \\\u003C 10 ml\u002Fmin\u002F1.73m2 during the 36-week study period. The projected decline will be estimated using the three most recent eGFR values from the previous 6-12 months\n\n* Ongoing\u002Fplanned dialysis\n* Systolic blood pressure \\\u003C 90 mmHg\n* Uncontrolled hypertension as judged by the investigator\n* Severe hepatic impairment (Child-Pugh C)\n* History of, or planned, heart transplantation or left ventricular assist device\n* Unwillingness to comply with highly effective contraceptive methods, or ongoing\u002Fplanned pregnancy, or breastfeeding\n* Previous allergic reaction to an MRA or a potassium binder\n* Ongoing treatment with lithium, cyclosporine, tacrolimus, nonsteroidal anti-inflammatory drugs, trimethoprim, or strong CYP3A inhibitors (ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, telithromycin, and nefazodone) or inducers (rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John's Wort)\n* QTc(f) ≥ 550 msec, history of QT prolongation associated with any medication requiring medication discontinuation, or congenital long QT syndrome\n* Uncontrolled arrhythmia as judged by the investigator\n* Acute cardiac hospitalization or procedure within four weeks before inclusion\n* Not suitable as judged by the investigator (presumed inability to participate, severe or terminal co-morbidity, and expected survival \\\u003C 12 months)\n* Previously enrolled in this trial or participation in another trial not approved for co-enrollment","ALL","18 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","Previous studies have shown that patients with heart failure with reduced pumping function and preserved kidney function experience improved symptoms, longer survival, and fewer hospitalizations when treated with medications such as eplerenone. However, individuals with impaired kidney function have been excluded from these trials due to concerns about potential adverse effects on potassium levels, kidney function, and possibly also blood pressure. As a result, clear treatment recommendations for this high-risk group are lacking.\n\nIn recent years, however, background therapies have been modernized and are now associated with a lower risk of potassium disturbances. Preliminary data also suggest that patients with impaired kidney function may benefit from eplerenone treatment. However, confirmation through dedicated studies is needed.\n\nThe primary objective of this pilot trial is to assess the feasibility and safety of eplerenone in patients with heart failure with reduced pumping function and impaired kidney function. Treatment effectiveness will also be explored.",[80,81],"HFrEF - Heart Failure With Reduced Ejection Fraction","Chronic Kidney Disease",[83,84,85,86,87,88,89,90,91,92,93,94,95,11,96,97],"HFrEF - Heart Failure with Reduced Ejection Fraction","Chronic kidney disease","Heart failure","Chronic heart failure","HFrEF","CKD","Renal dysfunction","Kidney dysfunction","Renal impairment","Advanced","Severe","Mineralocorticoid receptor antagonists","MRA","Sodium Zirconium Cyclosilicate","SZC","2026-02-21",{"date":100,"type":101},"2026-02-24","ACTUAL",{"date":103,"type":74},"2026-02",{"date":105,"type":74},"2027-10",{"name":5,"class":6},1]