Heart FailurePhase 4FINE-FOCUSNCT07583173
Effect of Finerenone on Myocardial Fibrosis and Cardiac Function in HFmrEF/HFpEF Patients
A Phase 4 study testing Oral finerenone in people with Heart Failure, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Oral finerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2026to 31 Dec 2027
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Beijing, 100037
Xiao Wang, MD, 86-10-88396953, wangxiao@fuwai.com
Yingying Guo, MD, 86-10-88396953, ying15836089137@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Oral finerenone, Placebo
- Keywords
- Heart failure with mildly reduced ejection fraction, Heart failure with preserved ejection fraction, Myocardial fibrosis, Imaging
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral finerenoneDrug
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.
PlaceboDrug
Standard heart failure therapy plus matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Not described Receives: Drug: Oral finerenone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CMR-measured extracellular volume (ECV) from baseline to Month 6 (∆ECV = ECV[post-treatment] - ECV[baseline])
Measured: 6 months
Secondary outcomes (17)
Change from baseline to 6 months in CMR-measured parameter: left ventricular end-diastolic volume index
Measured: 6 months
Change from baseline to 6 months in CMR-measured parameter: left ventricular end-systolic volume index
Measured: 6 months
Change from baseline to 6 months in CMR-measured parameter: left ventricular mass index
Measured: 6 months
Change from baseline to 6 months in CMR-measured parameter: left ventricular ejection fraction
Measured: 6 months
Change from baseline to 6 months in CMR-measured parameter: left atrial volume index
Measured: 6 months
Change from baseline to 6 months in CMR-measured parameter: left ventricular myocardial strain
Measured: 6 months
Change from baseline to 6 months in echocardiography-measured parameter: tricuspid regurgitation velocity
Measured: 6 months
Change from baseline to 6 months in echocardiography-measured parameter: E/e' ratio
Measured: 6 months
Change in CMR native T1 mapping from baseline to 6 months
Measured: 6 months
Change in LGE mass from baseline to 6 months
Measured: 6 months
Change in LGE percentage of left ventricular mass from baseline to 6 months
Measured: 6 months
Change in Pulmonary artery pressure by echocardiography from baseline to 6 months
Measured: 6 months
Change from baseline to 6 months in levels of NT-proBNP
Measured: 6 months
Change from baseline to 6 months in levels of total PINP
Measured: 6 months
Change from baseline to 6 months in levels of PIIINP
Measured: 6 months
Change from baseline to 6 months in levels of β-crosslaps
Measured: 6 months
Change from baseline to 6 months in levels of sST2
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start15 May 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xiao Wang, China National Center for Cardiovascular Diseases
- Investigators
- Ke fei Dou, MD, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical CollegeXiao Wang, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583173
- Sponsor's protocol ID
- 2025-2885
- Acronym
- FINE-FOCUS
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34385704Requena-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.
PubMed 34325888Mason 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.
PubMed 33454272Droebner 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.
PubMed 34515038Luettges 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.
PubMed 35675794Barton 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.
PubMed 36575058Agarwal 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.
PubMed 40470996Solomon 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.
PubMed 39225278Vaduganathan 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.
PubMed 38742248
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07583173
- Acronym / sponsor ID
- FINE-FOCUS / 2025-2885
- Conditions
- Heart Failure
- Keywords
- Heart failure with mildly reduced ejection fraction, Heart failure with preserved ejection fraction, Myocardial fibrosis, Imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 May 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: Oral finerenone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| Oral finerenoneStandard 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. | Drug | Finerenone |
| PlaceboStandard heart failure therapy plus matching placebo | Drug | Placebo |
Primary outcome
Change in CMR-measured extracellular volume (ECV) from baseline to Month 6 (∆ECV = ECV[post-treatment] - ECV[baseline])
Time frame: 6 months
17 secondary outcomes
Change from baseline to 6 months in CMR-measured parameter: left ventricular end-diastolic volume index
Time frame: 6 months
Change from baseline to 6 months in CMR-measured parameter: left ventricular end-systolic volume index
Time frame: 6 months
Change from baseline to 6 months in CMR-measured parameter: left ventricular mass index
Time frame: 6 months
Change from baseline to 6 months in CMR-measured parameter: left ventricular ejection fraction
Time frame: 6 months
Change from baseline to 6 months in CMR-measured parameter: left atrial volume index
Time frame: 6 months
Change from baseline to 6 months in CMR-measured parameter: left ventricular myocardial strain
Time frame: 6 months
Change from baseline to 6 months in echocardiography-measured parameter: tricuspid regurgitation velocity
Time frame: 6 months
Change from baseline to 6 months in echocardiography-measured parameter: E/e' ratio
Time frame: 6 months
Change in CMR native T1 mapping from baseline to 6 months
Time frame: 6 months
Change in LGE mass from baseline to 6 months
Time frame: 6 months
Change in LGE percentage of left ventricular mass from baseline to 6 months
Time frame: 6 months
Change in Pulmonary artery pressure by echocardiography from baseline to 6 months
Time frame: 6 months
Change from baseline to 6 months in levels of NT-proBNP
Time frame: 6 months
Change from baseline to 6 months in levels of total PINP
Time frame: 6 months
Change from baseline to 6 months in levels of PIIINP
Time frame: 6 months
Change from baseline to 6 months in levels of β-crosslaps
Time frame: 6 months
Change from baseline to 6 months in levels of sST2
Time frame: 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 13 May 2026.
- Background: PubMed 34385704Lewis 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.
- Background: PubMed 34325888Requena-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.
- Background: PubMed 33454272Mason 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.
- Background: PubMed 34515038Droebner 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.
- Background: PubMed 35675794Luettges 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.
- Background: PubMed 36575058Barton 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.
- Background: PubMed 40470996Agarwal 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.
- Background: PubMed 39225278Solomon 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.
- Background: PubMed 38742248Vaduganathan 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.
- Individual participant dataSharing planned: No
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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.
Ke fei Dou, MD principal investigator
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Xiao Wang principal investigator
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral finerenone in people with Heart Failure, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 7 inclusion and 15 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiao Wang, MD (86-10-88396953, wangxiao@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CMR-measured extracellular volume (ECV) from baseline to Month 6 (∆ECV = ECV[post-treatment] - ECV[baseline]) (time frame: 6 months). 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 NCT07583173, which also lists 9 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 13 May 2026.