Effect of Finerenone on Myocardial Fibrosis and Cardiac Function in HFmrEF/HFpEF Patients (FINE-FOCUS)

May 6, 2026 updated by: Xiao Wang, China National Center for Cardiovascular Diseases

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Finerenone on Myocardial Fibrosis and Cardiac Structure and Function in Heart Failure Patients With Mildly Reduced or Preserved Ejection Fraction

FINE-FOCUS study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the effect of Finerenone versus placebo on myocardial fibrosis and cardiac structure/function as assessed by cardiac magnetic resonance (CMR) in symptomatic heart failure patients with a left ventricular ejection fraction (LVEF) ≥40%. A sub-study will include 18F-FAPI-PET/CT imaging to evaluate the effect of finerenone on myocardial fibrosis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Heart failure (HF) with mildly reduced ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) are common and associated with high morbidity and mortality. A diverse range of pathophysiological mechanisms is involved in HFmrEF/HFpEF, and this heterogeneity has made it challenging to demonstrate a reduction in mortality in trials to date.

Preclinical studies have established myocardial fibrosis as a key pathophysiological driver of heart failure. In patients with HFmrEF/HFpEF, myocardial fibrosis, assessed by cardiovascular magnetic resonance, is associated with mortality and heart failure hospitalization. Finerenone is a non-steroidal mineralocorticoid receptor antagonist and exhibits more potent anti-inflammatory and antifibrotic effects than steroidal mineralocorticoid receptor antagonists in preclinical models.

Specifically targeting the extracellular matrix may represent a novel therapeutic approach for heart failure, the FINE-FOCUS study(A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Finerenone on Myocardial Fibrosis and Cardiac Structure and Function in Heart Failure Patients with Mildly Reduced or Preserved Ejection Fraction) was designed to test whether finerenone induces regression of myocardial fibrosis in patients with HFmrEF/HFpEF and evidence of myocardial fibrosis.

PET-CT substudy: A subset of eligible patients will be enrolled into a sub-study to evaluate the effect of finerenone on myocardial fibrosis assessed by 18F-FAPI-PET/CT.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100037
        • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
        • Principal Investigator:
          • Kefei Dou, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiao Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 to 80 years (inclusive), any gender.
  2. Symptomatic heart failure (NYHA class II-IV).
  3. Emergency department visit or hospitalization for HF within the past 3 months, or escalation of intravenous or oral diuretic therapy for worsening HF within the past 3 months.
  4. LVEF ≥40% measured by echocardiography or CMR within the past 30 days prior to screening.
  5. NT-proBNP ≥300 pg/mL for patients in sinus rhythm; NT-proBNP ≥900 pg/mL for patients with atrial fibrillation.
  6. Presence of myocardial fibrosis, defined as ECV ≥27% measured by CMR at baseline.
  7. Capable of providing voluntary written informed consent.

Exclusion Criteria:

  • 1. eGFR <25 mL/min/1.73 m² at screening or enrollment. 2. Serum potassium concentration ≥5.0 mmol/L at screening or enrollment. 3. Prior confirmed diagnosis of HFrEF. 4. Acute inflammatory heart disease (e.g., acute myocarditis). 5. Acute myocardial infarction or other event likely to have reduced LVEF within 30 days prior to randomization.

    6. Coronary artery bypass grafting within 30 days prior to randomization. 7. Percutaneous coronary intervention within 30 days prior to randomization. 8. History of stroke or transient ischemic attack (TIA) within 90 days prior to randomization.

    9. Conditions where the investigator considers the primary cause of dyspnea (and thus heart failure symptoms) to be severe pulmonary disease, anemia, or obesity. Specific exclusions include: severe pulmonary disease requiring home oxygen therapy or long-term oral steroids; history of primary pulmonary hypertension; hemoglobin <100 g/L; severe valvular heart disease; BMI ≥50 kg/m².

    10. Systolic blood pressure (SBP) >160 mmHg despite combination therapy with 3 antihypertensive drugs, OR SBP >180 mmHg on any treatment measured on (two consecutive occasions at least 2 minutes apart).

    11. Severe malignant ventricular arrhythmia or atrial fibrillation with resting ventricular rate >100 bpm.

    12. Symptomatic hypotension with mean SBP <90 mmHg. 13. Any HF condition requiring surgical intervention (e.g., severe aortic stenosis or mitral regurgitation).

    14. History of peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, primary right ventricular cardiomyopathy, constrictive pericarditis, hereditary hypertrophic cardiomyopathy, or infiltrative cardiomyopathy (including amyloidosis).

    15. Contraindications to CMR (e.g., magnetic metal implants, claustrophobia, contrast allergy).

    16. History of hyperkalemia or acute renal failure during prior MRA therapy. 17. Known allergy or severe adverse reaction to finerenone. 18. History of severe hepatic impairment (Child-Pugh C). 19. Requirement for any intravenous inotropic drugs or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) within 24 hours prior to randomization.

    20. Current or prior use (within 4 weeks before screening) of any MRA (e.g., spironolactone, eplerenone, canrenone, esaxerenone).

    21. Use of renin inhibitors or potassium-sparing diuretics prior to randomization that cannot be discontinued.

    22. Severe comorbidities (e.g., malignancy, lymphoma, cirrhosis, HIV-positive) with life expectancy <2 years.

    23. Pregnancy, lactation, or planning pregnancy. Women of childbearing potential must have a negative serum pregnancy test pre-treatment, agree to serum/urine pregnancy tests at study visits (Months 3 and 6), and commit to using highly effective contraception during the study and for 3 months after. Male participants with female partners of childbearing potential must also agree to use highly effective contraception during the study and for 3 months after.

    24. Participation in another clinical trial within 3 months prior to this study.

    25. Any condition, in the investigator's judgment, that would preclude safe study participation or protocol compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Standard heart failure therapy plus matching placebo
Experimental: Finerenone
Drug: Oral finerenone
Standard heart failure therapy plus oral finerenone eGFR ≤60 mL/min/1.73 m²: Start 10 mg once daily, target 20 mg once daily. eGFR >60 mL/min/1.73 m²: Start 20 mg once daily, target 40 mg once daily. Dose adjustments are mandated based on serum potassium levels and eGFR changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in CMR-measured extracellular volume (ECV) from baseline to Month 6 (∆ECV = ECV[post-treatment] - ECV[baseline])
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to 6 months in CMR-measured parameter: left ventricular end-diastolic volume index
Time Frame: 6 months
6 months
Change from baseline to 6 months in CMR-measured parameter: left ventricular end-systolic volume index
Time Frame: 6 months
6 months
Change from baseline to 6 months in CMR-measured parameter: left ventricular mass index
Time Frame: 6 months
6 months
Change from baseline to 6 months in CMR-measured parameter: left ventricular ejection fraction
Time Frame: 6 months
6 months
Change from baseline to 6 months in CMR-measured parameter: left atrial volume index
Time Frame: 6 months
6 months
Change from baseline to 6 months in CMR-measured parameter: left ventricular myocardial strain
Time Frame: 6 months
6 months
Change from baseline to 6 months in echocardiography-measured parameter: tricuspid regurgitation velocity
Time Frame: 6 months
6 months
Change from baseline to 6 months in echocardiography-measured parameter: E/e' ratio
Time Frame: 6 months
6 months
Change in CMR native T1 mapping from baseline to 6 months
Time Frame: 6 months
6 months
Change in LGE mass from baseline to 6 months
Time Frame: 6 months
6 months
Change in LGE percentage of left ventricular mass from baseline to 6 months
Time Frame: 6 months
6 months
Change in Pulmonary artery pressure by echocardiography from baseline to 6 months
Time Frame: 6 months
6 months
Change from baseline to 6 months in levels of NT-proBNP
Time Frame: 6 months
6 months
Change from baseline to 6 months in levels of total PINP
Time Frame: 6 months
6 months
Change from baseline to 6 months in levels of PIIINP
Time Frame: 6 months
6 months
Change from baseline to 6 months in levels of β-crosslaps
Time Frame: 6 months
6 months
Change from baseline to 6 months in levels of sST2
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Investigators

  • Principal Investigator: Ke fei Dou, MD, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
  • Principal Investigator: Xiao Wang, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-2885

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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