About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Evidenced heart failure with preserved ejection fraction (HFpEF) based on H2FPEF score.

Documented sinus rhythm at screening by resting ECG and Holter.

Disqualifiers

Any history of documented atrial fibrillation, atrial flutter, or atrial tachycardia.

Presence of conduction abnormalities such as LBBB or RBBB.

Presence of an implanted cardiac pacemaker or defibrillator with active atrial pacing.

Presence of significant valvular dysfunction.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Finerenone
Drug
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.
Placebo
Drug
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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: HFpEF patients in sinus rhythm receiving Finerenone1 intervention

Group B: HFpEF patients in sinus rhythm receiving a placebo1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Locations

This trial has no locations.

Finerenone's Impact on Cardiac Electrical Stability in HFpEF