[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659575":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":22,"studyPopulation":23,"armGroups":24,"interventions":35,"overallOfficials":18,"centralContacts":44,"locations":18,"responsibleParty":50,"collaborators":18,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":18,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":18,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":18,"briefSummary":11,"conditions":67,"keywords":71,"overallStatus":76,"whyStopped":18,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":18},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Time to first documented occurrence of any atrial or ventricular tachyarrhythmia on a 12-lead ECG or 24-hour Holter monitor during the 6-month study period.","To evaluate the efficacy of finerenone in reducing the incidence of any electrical instability or arrhythmias in the form of new-onset atrial fibrillation or atrial flutter (AFF), atrial tachycardia, extrasystoles (premature atrial and ventricular contractions, PACs and PVCs, respectively), ventricular arrhythmias, bradycardia, in patients with heart failure with preserved ejection fraction who are in sinus rhythm.","Baseline",[14],{"measure":15,"description":16,"timeFrame":17},"Change in LA and LV structure and function from baseline to 6 months.","1. Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to 6 Months assessed using 2D transthoracic echocardiography via the biplane Simpson's method, reported as a percentage (%).\n2. Change in Left Atrial Volume Index (LAVI) from Baseline to 6 Months measured via transthoracic echocardiography using the biplane area-length method indexed to body surface area, reported in mL\u002Fm2.\n3. Change in Early Diastolic Mitral Inflow to Mitral Annular Tissue Velocity Ratio (E\u002Fe') from Baseline to 6 Months measured by combining pulsed-wave Doppler for mitral inflow (E) and tissue Doppler imaging at the mitral annulus (e' average of septal and lateral), reported as a unitless ratio.\n4. Left ventricular internal end-diastolic diameter (LVEDD) and end-systolic diameter (LVESD) measured by transthoracic echocardiography in millimeters (mm).","Baseline up to 6 months",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"COHORT","PROSPECTIVE","Overactivation of the mineralocorticoid receptor (MR) drives persistent tissue inflammation, oxidative stress, and fibrosis, accelerating progressive chronic kidney disease (CKD) and heart failure(1). Therapeutic MR blockade is crucial to mitigate these cardiorenal risks.\n\nFor decades, the first-generation steroidal MR antagonist (MRA), Spironolactone, has been widely utilized. However, its clinical utility is frequently limited by high renal accumulation, which predisposes high-risk patients to severe hyperkalemia. Furthermore, structural similarities to sex hormones induce poorly tolerated, off-target endocrine side effects like gynecomastia, substantially lowering long-term patient compliance(1,2).\n\nFinerenone represents a major pharmacological breakthrough as a highly selective, non-steroidal MRA. Its unique, rigid, bulky core structure binds to the MR with exceptional selectivity, displaying negligible affinity for progesterone, androgen, or glucocorticoid receptors-effectively eliminating endocrine adverse effects(1,2). Furthermore, Finerenone exhibits a balanced, uniform physical distribution between cardiac and renal tissues. Large-scale clinical trial programs have demonstrated that Finerenone delivers potent anti-fibrotic protection with a significantly lower risk of treatment-limiting hyperkalemia compared to historical data for steroidal MRAs(1,3).\n\nWhile landmark trials have robustly validated Finerenone against placebos, a critical gap in direct, head-to-head clinical evidence remains(4,5). Clear clinical equipoise persists regarding whether Finerenone offers superior cardiorenal protection and a more favorable safety profile when compared directly against standard active therapy.","The registry will enroll patients with clinically evidenced heart failure based on the H2FPEF score. Heart failure with preserved ejection fraction (HFpEF) will be identified using the H₂FPEF score, a validated clinical diagnostic tool developed to estimate the likelihood of HFpEF in patients presenting with unexplained dyspnoea and preserved left ventricular ejection fraction (LVEF ≥50%). Scores range from 0 to 9, with scores of 6-9 indicating a high probability of HFpEF, 2-5 an intermediate probability, and 0-1 a low probability. For the present study, patients with a high-probability H₂FPEF score (≥6), together with preserved LVEF and clinical features consistent with HFpEF, will be considered eligible for recruitment.",[25,30],{"label":26,"type":18,"description":27,"interventionNames":28},"HFpEF patients in sinus rhythm receiving Finerenone","The registry will enroll patients with clinically evidenced heart failure, as determined by the H2FPEF score. For the present study, patients with a high-probability H₂FPEF score (≥6), preserved LVEF, and clinical features consistent with HFpEF will be considered eligible for recruitment. This group will receive Finerenone.",[29],"Drug: Finerenone",{"label":31,"type":18,"description":32,"interventionNames":33},"HFpEF patients in sinus rhythm receiving a placebo","The registry will enroll patients with clinically evidenced heart failure, as determined by the H2FPEF score. For the present study, patients with a high-probability H₂FPEF score (≥6), preserved LVEF, and clinical features consistent with HFpEF will be considered eligible for recruitment. This group will receive a placebo.",[34],"Drug: Placebo",[36,40],{"type":37,"name":38,"description":11,"armGroupLabels":39,"otherNames":18},"DRUG","Finerenone",[26],{"type":37,"name":41,"description":42,"armGroupLabels":43,"otherNames":18},"Placebo","To evaluate the incidence of any electrical instability or arrhythmias in the form of new-onset atrial fibrillation or atrial flutter (AFF), atrial tachycardia, extrasystoles (premature atrial and ventricular contractions, PACs and PVCs, respectively), ventricular arrhythmias, bradycardia, in patients with heart failure with preserved ejection fraction who are in sinus rhythm receiving a placebo.",[31],[45],{"name":46,"role":47,"phone":48,"phoneExt":18,"email":49},"Yousef Abolela Ahmed","CONTACT","+201096071339","yousefabolela@med.aun.edu.eg",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Yousef Abolela Ahmed Abolela","Cardiology Resident","100659575","finerenones-impact-on-cardiac-electrical-stability-in-hfpef-100659575",false,"NCT07866287","Finerenone's Impact on Cardiac Electrical Stability in HFpEF","Impact of Finerenone on Cardiac Electrical Stability in Patients With Heart Failure With Preserved Ejection Fraction","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Evidenced heart failure with preserved ejection fraction (HFpEF) based on H2FPEF score.\n* Documented sinus rhythm at screening by resting ECG and Holter.\n\nExclusion Criteria:\n\n* Any history of documented atrial fibrillation, atrial flutter, or atrial tachycardia.\n* Presence of conduction abnormalities such as LBBB or RBBB.\n* Presence of an implanted cardiac pacemaker or defibrillator with active atrial pacing.\n* Presence of significant valvular dysfunction.\n* Estimated glomerular filtration rate (eGFR)\\\u003C25 mL\u002Fmin\u002F1.73m2 at screening.\n* Baseline serum potassium level\\>5 mEq\u002FL.\n* Severe liver impairment.\n* Marked electrolyte imbalance.","ALL","18 Years",{"count":64,"type":65},100,"ESTIMATED","OBSERVATIONAL",[68,69,70],"Heart Failure and Preserved Ejection Fraction","Atrial Fibrillation (AF)","Arrythmia",[72,73,74,75],"electrical instability","HFpEF","AF","Holter","NOT_YET_RECRUITING","2026-10-07",{"date":79,"type":80},"2026-10-08","ACTUAL",{"date":82,"type":65},"2026-10-01",{"date":84,"type":65},"2027-12-01",{"name":5,"class":6}]