Heart Failure and Preserved Ejection FractionNCT07866287
Finerenone's Impact on Cardiac Electrical Stability in HFpEF
An observational study of Heart Failure and Preserved Ejection Fraction and Atrial Fibrillation (AF), run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure and Preserved Ejection Fraction, Atrial Fibrillation (AF), Arrythmia
- What is being tested?
- Finerenone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
- Estimated glomerular filtration rate (eGFR)<25 mL/min/1.73m2 at screening.
- Baseline serum potassium level>5 mEq/L.
- Severe liver impairment.
- Marked electrolyte imbalance.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Finerenone on Cardiac Electrical Stability in Patients With Heart Failure With Preserved Ejection Fraction
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.
Read the detailed description
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.
- Being tested
- Finerenone, Placebo
- Keywords
- electrical instability, HFpEF, AF, Holter
- Medical subject headings
- Heart Failure, Diastolic, Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Finerenone | |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
Change in LA and LV structure and function from baseline to 6 months.
- 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 (%).
- 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.
- 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.
- Left ventricular internal end-diastolic diameter (LVEDD) and end-systolic diameter (LVESD) measured by transthoracic echocardiography in millimeters (mm).
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure and Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousef Abolela Ahmed Abolela, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866287
- Sponsor's protocol ID
- Finerenone and arrythmias
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Pabon MA, Filippatos G, Claggett BL, Miao MZ, Desai AS, Jhund PS, Henderson A, Brinker M, Schloemer P, Hofmeister L, Li L, Lam CSP, Senni M, Shah SJ, Voors AA, Zannad F, Rossing P, Ruilope LM, Anker SD, Pitt B, Agarwal R, McMurray JJV, Solomon SD, Vaduganathan M. Finerenone Reduces New-Onset Atrial Fibrillation Across the Spectrum of Cardio-Kidney-Metabolic Syndrome: The FINE-HEART Pooled Analysis. J Am Coll Cardiol. 2025 May 6;85(17):1649-1660. doi: 10.1016/j.jacc.2025.03.429. Epub 2025 Mar 17.
PubMed 40306837Matsumoto S, Henderson AD, Jhund PS, Bauersachs J, Chioncel O, Claggett BL, Comin-Colet J, Desai AS, Filippatos G, Lam CSP, Pitt B, Scheerer MF, Lay-Flurrie J, Amarante F, Brinker M, Schou M, Senni M, Shah SJ, Voors AA, Zannad F, Zieroth S, Vaduganathan M, Solomon SD, McMurray JJV. Finerenone and Atrial Fibrillation in Heart Failure: A Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial. JAMA Cardiol. 2025 Jul 1;10(7):696-707. doi: 10.1001/jamacardio.2025.0848.
PubMed 40156827Filippatos G, Bakris GL, Pitt B, Agarwal R, Rossing P, Ruilope LM, Butler J, Lam CSP, Kolkhof P, Roberts L, Tasto C, Joseph A, Anker SD; FIDELIO-DKD Investigators. Finerenone Reduces New-Onset Atrial Fibrillation in Patients With Chronic Kidney Disease and Type 2 Diabetes. J Am Coll Cardiol. 2021 Jul 13;78(2):142-152. doi: 10.1016/j.jacc.2021.04.079. Epub 2021 May 17.
PubMed 34015478
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Finerenone on Cardiac Electrical Stability in Patients With Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT07866287
- Acronym / sponsor ID
- Finerenone and arrythmias
- Keywords
- electrical instability, HFpEF, AF, Holter
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFpEF patients in sinus rhythm receiving Finerenone | – | Drug: FinerenoneThe 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. |
| HFpEF patients in sinus rhythm receiving a placebo | – | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- Estimated glomerular filtration rate (eGFR)<25 mL/min/1.73m2 at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinerenoneTo 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. | Drug | HFpEF patients in sinus rhythm receiving Finerenone |
| PlaceboTo 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. | Drug | HFpEF patients in sinus rhythm receiving a placebo |
Primary outcome
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.
Time frame: Baseline
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.
1 secondary outcome
Change in LA and LV structure and function from baseline to 6 months.
Time frame: Baseline up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 40306837Pabon MA, Filippatos G, Claggett BL, Miao MZ, Desai AS, Jhund PS, Henderson A, Brinker M, Schloemer P, Hofmeister L, Li L, Lam CSP, Senni M, Shah SJ, Voors AA, Zannad F, Rossing P, Ruilope LM, Anker SD, Pitt B, Agarwal R, McMurray JJV, Solomon SD, Vaduganathan M. Finerenone Reduces New-Onset Atrial Fibrillation Across the Spectrum of Cardio-Kidney-Metabolic Syndrome: The FINE-HEART Pooled Analysis. J Am Coll Cardiol. 2025 May 6;85(17):1649-1660. doi: 10.1016/j.jacc.2025.03.429. Epub 2025 Mar 17.
- Background: PubMed 40156827Matsumoto S, Henderson AD, Jhund PS, Bauersachs J, Chioncel O, Claggett BL, Comin-Colet J, Desai AS, Filippatos G, Lam CSP, Pitt B, Scheerer MF, Lay-Flurrie J, Amarante F, Brinker M, Schou M, Senni M, Shah SJ, Voors AA, Zannad F, Zieroth S, Vaduganathan M, Solomon SD, McMurray JJV. Finerenone and Atrial Fibrillation in Heart Failure: A Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial. JAMA Cardiol. 2025 Jul 1;10(7):696-707. doi: 10.1001/jamacardio.2025.0848.
- Background: PubMed 34015478Filippatos G, Bakris GL, Pitt B, Agarwal R, Rossing P, Ruilope LM, Butler J, Lam CSP, Kolkhof P, Roberts L, Tasto C, Joseph A, Anker SD; FIDELIO-DKD Investigators. Finerenone Reduces New-Onset Atrial Fibrillation in Patients With Chronic Kidney Disease and Type 2 Diabetes. J Am Coll Cardiol. 2021 Jul 13;78(2):142-152. doi: 10.1016/j.jacc.2021.04.079. Epub 2021 May 17.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Preserved Ejection Fraction and Atrial Fibrillation (AF), run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yousef Abolela Ahmed (+201096071339, yousefabolela@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07866287, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.