Effect of Finerenone on Myocardial Fibrosis and Cardiac Function in HFmrEF/HFpEF Patients

NCT07583173 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2025-2885
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart failure with mildly reduced ejection fraction; Heart failure with preserved ejection fraction; Myocardial fibrosis; Imaging

Outcome Measures

Primary Outcomes (1)

• Change in CMR-measured extracellular volume (ECV) from baseline to Month 6 (∆ECV = ECV[post-treatment] - ECV[baseline])

  6 months

Secondary Outcomes (17)

• Change from baseline to 6 months in CMR-measured parameter: left ventricular end-diastolic volume index

  6 months

• Change from baseline to 6 months in CMR-measured parameter: left ventricular end-systolic volume index

  6 months

• Change from baseline to 6 months in CMR-measured parameter: left ventricular mass index

  6 months

• Change from baseline to 6 months in CMR-measured parameter: left ventricular ejection fraction

  6 months

• Change from baseline to 6 months in CMR-measured parameter: left atrial volume index

  6 months

Study Arms (2)

Finerenone

EXPERIMENTAL

Drug: Oral finerenone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oral finerenone DRUG

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.

Finerenone

Placebo DRUG

Standard heart failure therapy plus matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 80 years (inclusive), any gender.
• Symptomatic heart failure (NYHA class II-IV).
• 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.
• LVEF ≥40% measured by echocardiography or CMR within the past 30 days prior to screening.
• NT-proBNP ≥300 pg/mL for patients in sinus rhythm; NT-proBNP ≥900 pg/mL for patients with atrial fibrillation.
• Presence of myocardial fibrosis, defined as ECV ≥27% measured by CMR at baseline.
• Capable of providing voluntary written informed consent.

You may not qualify if:

• \. 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.
• \. 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.
• \. 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).
• \. Severe malignant ventricular arrhythmia or atrial fibrillation with resting ventricular rate \>100 bpm.
• \. Symptomatic hypotension with mean SBP \<90 mmHg. 13. Any HF condition requiring surgical intervention (e.g., severe aortic stenosis or mitral regurgitation).
• \. History of peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, primary right ventricular cardiomyopathy, constrictive pericarditis, hereditary hypertrophic cardiomyopathy, or infiltrative cardiomyopathy (including amyloidosis).
• \. Contraindications to CMR (e.g., magnetic metal implants, claustrophobia, contrast allergy).
• \. 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.
• \. Current or prior use (within 4 weeks before screening) of any MRA (e.g., spironolactone, eplerenone, canrenone, esaxerenone).
• \. Use of renin inhibitors or potassium-sparing diuretics prior to randomization that cannot be discontinued.
• \. Severe comorbidities (e.g., malignancy, lymphoma, cirrhosis, HIV-positive) with life expectancy \<2 years.
• \. 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.
• \. Participation in another clinical trial within 3 months prior to this study.
• \. Any condition, in the investigator's judgment, that would preclude safe study participation or protocol compliance.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Beijing, 100037, China

Location

Related Publications (9)

• Lewis GA, Dodd S, Clayton D, Bedson E, Eccleson H, Schelbert EB, Naish JH, Jimenez BD, Williams SG, Cunnington C, Ahmed FZ, Cooper A, Rajavarma Viswesvaraiah, Russell S, McDonagh T, Williamson PR, Miller CA. Pirfenidone in heart failure with preserved ejection fraction: a randomized phase 2 trial. Nat Med. 2021 Aug;27(8):1477-1482. doi: 10.1038/s41591-021-01452-0. Epub 2021 Aug 12.

  PMID: 34385704 BACKGROUND

• Requena-Ibanez JA, Santos-Gallego CG, Rodriguez-Cordero A, Vargas-Delgado AP, Mancini D, Sartori S, Atallah-Lajam F, Giannarelli C, Macaluso F, Lala A, Sanz J, Fuster V, Badimon JJ. Mechanistic Insights of Empagliflozin in Nondiabetic Patients With HFrEF: From the EMPA-TROPISM Study. JACC Heart Fail. 2021 Aug;9(8):578-589. doi: 10.1016/j.jchf.2021.04.014.

  PMID: 34325888 BACKGROUND

• Mason T, Coelho-Filho OR, Verma S, Chowdhury B, Zuo F, Quan A, Thorpe KE, Bonneau C, Teoh H, Gilbert RE, Leiter LA, Juni P, Zinman B, Jerosch-Herold M, Mazer CD, Yan AT, Connelly KA. Empagliflozin Reduces Myocardial Extracellular Volume in Patients With Type 2 Diabetes and Coronary Artery Disease. JACC Cardiovasc Imaging. 2021 Jun;14(6):1164-1173. doi: 10.1016/j.jcmg.2020.10.017. Epub 2021 Jan 13.

  PMID: 33454272 BACKGROUND

• Droebner K, Pavkovic M, Grundmann M, Hartmann E, Goea L, Nordlohne J, Klar J, Eitner F, Kolkhof P. Direct Blood Pressure-Independent Anti-Fibrotic Effects by the Selective Nonsteroidal Mineralocorticoid Receptor Antagonist Finerenone in Progressive Models of Kidney Fibrosis. Am J Nephrol. 2021;52(7):588-601. doi: 10.1159/000518254. Epub 2021 Aug 30.

  PMID: 34515038 BACKGROUND

• Luettges K, Bode M, Diemer JN, Schwanbeck J, Wirth EK, Klopfleisch R, Kappert K, Thiele A, Ritter D, Foryst-Ludwig A, Kolkhof P, Wenzel UO, Kintscher U. Finerenone Reduces Renal RORgammat gammadelta T Cells and Protects against Cardiorenal Damage. Am J Nephrol. 2022;53(7):552-564. doi: 10.1159/000524940. Epub 2022 Jun 8.

  PMID: 35675794 BACKGROUND

• Barton AK, Tzolos E, Bing R, Singh T, Weber W, Schwaiger M, Varasteh Z, Slart RHJA, Newby DE, Dweck MR. Emerging molecular imaging targets and tools for myocardial fibrosis detection. Eur Heart J Cardiovasc Imaging. 2023 Feb 17;24(3):261-275. doi: 10.1093/ehjci/jeac242.

  PMID: 36575058 BACKGROUND

• Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE Investigators. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025 Aug 7;393(6):533-543. doi: 10.1056/NEJMoa2410659. Epub 2025 Jun 5.

  PMID: 40470996 BACKGROUND

• Solomon SD, McMurray JJV, Vaduganathan M, Claggett B, Jhund PS, Desai AS, Henderson AD, Lam CSP, Pitt B, Senni M, Shah SJ, Voors AA, Zannad F, Abidin IZ, Alcocer-Gamba MA, Atherton JJ, Bauersachs J, Chang-Sheng M, Chiang CE, Chioncel O, Chopra V, Comin-Colet J, Filippatos G, Fonseca C, Gajos G, Goland S, Goncalvesova E, Kang S, Katova T, Kosiborod MN, Latkovskis G, Lee AP, Linssen GCM, Llamas-Esperon G, Mareev V, Martinez FA, Melenovsky V, Merkely B, Nodari S, Petrie MC, Saldarriaga CI, Saraiva JFK, Sato N, Schou M, Sharma K, Troughton R, Udell JA, Ukkonen H, Vardeny O, Verma S, von Lewinski D, Voronkov L, Yilmaz MB, Zieroth S, Lay-Flurrie J, van Gameren I, Amarante F, Kolkhof P, Viswanathan P; FINEARTS-HF Committees and Investigators. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2024 Oct 24;391(16):1475-1485. doi: 10.1056/NEJMoa2407107. Epub 2024 Sep 1.

  PMID: 39225278 BACKGROUND

• Vaduganathan M, Claggett BL, Lam CSP, Pitt B, Senni M, Shah SJ, Voors AA, Zannad F, Desai AS, Jhund PS, Viswanathan P, Bomfim Wirtz A, Schloemer P, Lay-Flurrie J, McMurray JJV, Solomon SD. Finerenone in patients with heart failure with mildly reduced or preserved ejection fraction: Rationale and design of the FINEARTS-HF trial. Eur J Heart Fail. 2024 Jun;26(6):1324-1333. doi: 10.1002/ejhf.3253. Epub 2024 May 14.

  PMID: 38742248 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

finerenone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Wang, MD

CONTACT

86-10-88396953; wangxiao@fuwai.com

Yingying Guo, MD

CONTACT

86-10-88396953; ying15836089137@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 13, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)