An observational study in Heart Failure and Preserved Ejection Fraction, Atrial Fibrillation (AF) and Arrythmia, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Assiut University · Observational
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.
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.
For 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).
Finerenone 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).
While 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.
180 studies on the registry are indexed under Heart Failure, Diastolic; 38 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 48 observational studies indexed under Heart Failure, Diastolic.
Browse Heart Failure, Diastolic studies →Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Exclusion Criteria:
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.
Drug: 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 a placebo.
Drug: Placebo
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.
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.
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.
Time frame: Baseline
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 (%). 2. 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/m2. 3. Change in Early Diastolic Mitral Inflow to Mitral Annular Tissue Velocity Ratio (E/e') 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. 4. Left ventricular internal end-diastolic diameter (LVEDD) and end-systolic diameter (LVESD) measured by transthoracic echocardiography in millimeters (mm).
Time frame: Baseline up to 6 months
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data relevant to the study outcomes will be shared, including demographic characteristics, clinical history, vital signs, laboratory investigations, echocardiographic parameters, medication history, treatment-related data, and study outcome measures. No directly identifiable personal information will be shared.
Supporting information: Study protocol
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Assiut University