Pub Date : 2026-01-01DOI: 10.1016/j.jchf.2025.102754
Quan M. Bui MD, Kimberly N. Hong MD, MHSA
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Pub Date : 2026-01-01DOI: 10.1016/j.jchf.2025.03.007
John W. Ostrominski MD , Muthiah Vaduganathan MD, MPH , Brian L. Claggett PhD , Akshay S. Desai MD, MPH , Pardeep S. Jhund MBChB, MSc, PhD , Carolyn S.P. Lam MD, PhD , Michele Senni MD , Sanjiv J. Shah MD , Adriaan A. Voors MD , Faiez Zannad MD , Bertram Pitt MD , Maria Borentian MD , Katja Rohwedder MD , James Lay-Flurrie MSc , Marco Antonio Lavagnino MD , John J.V. McMurray MD , Scott D. Solomon MD
Background
The NYHA functional classification remains an important and widely used metric in heart failure (HF)-oriented clinical care and research.
Objectives
This study aims to evaluate whether the effect of finerenone varies according to NYHA functional class in HF with mildly reduced or preserved ejection fraction.
Methods
In this prespecified analysis of the FINEARTS-HF trial, treatment effects of finerenone according to baseline NYHA functional class (II or III/IV) were examined on the primary endpoint (cardiovascular death and total HF events) and key secondary endpoints. Effects of finerenone on change in NYHA functional class were evaluated using ordinal logistic regression.
Results
At baseline, 4,146 (69%) and 1,854 (31%) participants were NYHA functional class II and III/IV, respectively. Participants with baseline NYHA functional class III/IV vs II experienced a significantly higher rate of cardiovascular death and total HF events (adjusted rate ratio: 1.28 [95% CI: 1.11-1.46]; P < 0.001). Finerenone consistently reduced the primary endpoint irrespective of baseline NYHA functional class (Pinteraction = 0.54), with greater absolute benefits in NYHA functional class III/IV (absolute rate reduction [ARR]: 4.5 per 100 person-years) vs II (ARR: 2.0 per 100 person-years). Benefits of finerenone on Kansas City Cardiomyopathy Questionnaire–Total Symptom Score at 12 months were consistent irrespective of NYHA functional class (Pinteraction = 0.93). NYHA functional class improved similarly in the finerenone and placebo arms out to 12 months. The safety profile of finerenone was similar among participants with baseline NYHA functional class III/IV vs II.
Conclusions
In this FINEARTS-HF analysis, finerenone reduced clinical outcomes and improved patient-reported health status in HF with mildly reduced or preserved ejection fraction irrespective of baseline NYHA functional class. (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure [FINEARTS-HF]; NCT04435626)
{"title":"Finerenone and NYHA Functional Class in Heart Failure","authors":"John W. Ostrominski MD , Muthiah Vaduganathan MD, MPH , Brian L. Claggett PhD , Akshay S. Desai MD, MPH , Pardeep S. Jhund MBChB, MSc, PhD , Carolyn S.P. Lam MD, PhD , Michele Senni MD , Sanjiv J. Shah MD , Adriaan A. Voors MD , Faiez Zannad MD , Bertram Pitt MD , Maria Borentian MD , Katja Rohwedder MD , James Lay-Flurrie MSc , Marco Antonio Lavagnino MD , John J.V. McMurray MD , Scott D. Solomon MD","doi":"10.1016/j.jchf.2025.03.007","DOIUrl":"10.1016/j.jchf.2025.03.007","url":null,"abstract":"<div><h3>Background</h3><div>The NYHA functional classification remains an important and widely used metric in heart failure (HF)-oriented clinical care and research.</div></div><div><h3>Objectives</h3><div>This study aims to evaluate whether the effect of finerenone varies according to NYHA functional class in HF with mildly reduced or preserved ejection fraction.</div></div><div><h3>Methods</h3><div>In this prespecified analysis of the FINEARTS-HF trial, treatment effects of finerenone according to baseline NYHA functional class (II or III/IV) were examined on the primary endpoint (cardiovascular death and total HF events) and key secondary endpoints. Effects of finerenone on change in NYHA functional class were evaluated using ordinal logistic regression.</div></div><div><h3>Results</h3><div>At baseline, 4,146 (69%) and 1,854 (31%) participants were NYHA functional class II and III/IV, respectively. Participants with baseline NYHA functional class III/IV vs II experienced a significantly higher rate of cardiovascular death and total HF events (adjusted rate ratio: 1.28 [95% CI: 1.11-1.46]; <em>P <</em> 0.001). Finerenone consistently reduced the primary endpoint irrespective of baseline NYHA functional class (<em>P</em><sub>interaction</sub> = 0.54), with greater absolute benefits in NYHA functional class III/IV (absolute rate reduction [ARR]: 4.5 per 100 person-years) vs II (ARR: 2.0 per 100 person-years). Benefits of finerenone on Kansas City Cardiomyopathy Questionnaire–Total Symptom Score at 12 months were consistent irrespective of NYHA functional class (<em>P</em><sub>interaction</sub> = 0.93). NYHA functional class improved similarly in the finerenone and placebo arms out to 12 months. The safety profile of finerenone was similar among participants with baseline NYHA functional class III/IV vs II.</div></div><div><h3>Conclusions</h3><div>In this FINEARTS-HF analysis, finerenone reduced clinical outcomes and improved patient-reported health status in HF with mildly reduced or preserved ejection fraction irrespective of baseline NYHA functional class. (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure [FINEARTS-HF]; <span><span>NCT04435626</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"14 1","pages":"Article 102440"},"PeriodicalIF":11.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143996639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.jchf.2025.102716
Paul J. Kim MD, MAS , Amit H. Alam MD , Jeffrey J. Teuteberg MD , Kiran K. Khush MD, MAS , Sean P. Pinney MD , Richard K. Cheng MD, MSc , Amin Yehya MD , Jeremy Kobulnik MD , Kevin M. Pinney BS , Kris A. Oreschak PhD , Christopher R. Ensor PharmD , Steve Fan PhD , Marcus A. Urey MD , Palak Shah MD , Shelley A. Hall MD
Background
Donor-derived cell-free DNA (dd-cfDNA) has emerged as a biomarker for antibody-mediated rejection (AMR), but its performance characteristics have not been evaluated in a large contemporary heart transplant population.
Objectives
The study aimed to characterize the incidence and timing of biopsy-proven AMR and evaluate the performance characteristics of dd-cfDNA for AMR.
Methods
The authors included 2,240 subjects from the SHORE (Surveillance HeartCare Outcomes Registry) registry transplanted between 2017 and 2022 with verified biopsy, dd-cfDNA, echocardiographic, and donor-specific antibody (DSA) data. They evaluated the performance characteristics of dd-cfDNA for AMR and the incidence of AMR in different clinical contexts.
Results
AMR was present in 2.6% of biopsies with significant variability depending on the clinical context: AMR occurred in 1.1% of biopsies with normal graft function and no DSAs vs 20.4% of biopsies with known DSA and graft dysfunction. In patients with neither DSA nor graft dysfunction, the incidence of AMR was 0.7% for dd-cfDNA levels <0.20%, 1.2% for levels between 0.20% and 0.49%, and 6.7% for dd-cfDNA levels ≥0.50%. In patients with known DSA but no graft dysfunction, the incidence of AMR was 1.4% for dd-cfDNA levels <0.20%, 4.8% for levels between 0.20% and 0.49%, and 15.5% for dd-cfDNA levels ≥0.50%.
Conclusions
The authors document significant context dependent variability of AMR incidence and the utility of dd-cfDNA in predicting biopsy yield. These data complement prior studies on the interpretation of peripheral gene expression profiling and dd-cfDNA for rejection monitoring and should further obviate the need for surveillance biopsies. (Surveillance HeartCare Outcomes Registry [SHORE]; NCT03695601)
{"title":"Donor-Derived Cell-Free DNA in Antibody-Mediated Rejection","authors":"Paul J. Kim MD, MAS , Amit H. Alam MD , Jeffrey J. Teuteberg MD , Kiran K. Khush MD, MAS , Sean P. Pinney MD , Richard K. Cheng MD, MSc , Amin Yehya MD , Jeremy Kobulnik MD , Kevin M. Pinney BS , Kris A. Oreschak PhD , Christopher R. Ensor PharmD , Steve Fan PhD , Marcus A. Urey MD , Palak Shah MD , Shelley A. Hall MD","doi":"10.1016/j.jchf.2025.102716","DOIUrl":"10.1016/j.jchf.2025.102716","url":null,"abstract":"<div><h3>Background</h3><div>Donor-derived cell-free DNA (dd-cfDNA) has emerged as a biomarker for antibody-mediated rejection (AMR), but its performance characteristics have not been evaluated in a large contemporary heart transplant population.</div></div><div><h3>Objectives</h3><div>The study aimed to characterize the incidence and timing of biopsy-proven AMR and evaluate the performance characteristics of dd-cfDNA for AMR.</div></div><div><h3>Methods</h3><div>The authors included 2,240 subjects from the SHORE (Surveillance HeartCare Outcomes Registry) registry transplanted between 2017 and 2022 with verified biopsy, dd-cfDNA, echocardiographic, and donor-specific antibody (DSA) data. They evaluated the performance characteristics of dd-cfDNA for AMR and the incidence of AMR in different clinical contexts.</div></div><div><h3>Results</h3><div>AMR was present in 2.6% of biopsies with significant variability depending on the clinical context: AMR occurred in 1.1% of biopsies with normal graft function and no DSAs vs 20.4% of biopsies with known DSA and graft dysfunction. In patients with neither DSA nor graft dysfunction, the incidence of AMR was 0.7% for dd-cfDNA levels <0.20%, 1.2% for levels between 0.20% and 0.49%, and 6.7% for dd-cfDNA levels ≥0.50%. In patients with known DSA but no graft dysfunction, the incidence of AMR was 1.4% for dd-cfDNA levels <0.20%, 4.8% for levels between 0.20% and 0.49%, and 15.5% for dd-cfDNA levels ≥0.50%.</div></div><div><h3>Conclusions</h3><div>The authors document significant context dependent variability of AMR incidence and the utility of dd-cfDNA in predicting biopsy yield. These data complement prior studies on the interpretation of peripheral gene expression profiling and dd-cfDNA for rejection monitoring and should further obviate the need for surveillance biopsies. (Surveillance HeartCare Outcomes Registry [SHORE]; <span><span>NCT03695601</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"14 1","pages":"Article 102716"},"PeriodicalIF":11.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145338759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.jchf.2025.03.006
John W. Ostrominski MD , Finnian R. Mc Causland MBBCh, MMSc , Brian L. Claggett PhD , Akshay S. Desai MD MPH , Pardeep S. Jhund MBChB, MSc, PhD , Carolyn S.P. Lam MD, PhD , Michele Senni MD , Sanjiv J. Shah MD , Adriaan A. Voors MD , Faiez Zannad MD , Bertram Pitt MD , Patrick Schloemer PhD , Meike Brinker MD , Markus F. Scheerer PhD , John J.V. McMurray MD , Scott D. Solomon MD , Muthiah Vaduganathan MD, MPH
Background
Estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio are complementary domains of kidney disease staging and independently associated with heart failure (HF) progression.
Objectives
The purpose of this study was to evaluate whether the efficacy and safety of finerenone varies according to kidney risk among patients with HF with mildly reduced or preserved ejection fraction.
Methods
In this prespecified analysis of FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure), clinical outcomes and treatment effects of finerenone on the primary endpoint (cardiovascular death and total [first and recurrent] HF events) and key secondary endpoints were evaluated according to baseline KDIGO (Kidney Disease: Improving Global Outcomes) risk category (low, moderately increased, and high or very high). Key exclusion criteria in FINEARTS-HF were eGFR <25 mL/min/1.73 m2 or serum potassium >5.0 mmol/L.
Results
Overall, 5,797 (97%) FINEARTS-HF participants had classifiable KDIGO risk category at baseline, of whom 2,022 (35%), 1,688 (29%), and 2,087 (36%) were low, moderate, and high/very high risk, respectively. Over a median follow-up of 2.7 years, higher kidney risk was associated with a higher rate of primary outcome events, with similar findings for other key endpoints, including the composite kidney outcome, new-onset atrial fibrillation, and vascular events. Benefits of finerenone vs placebo on the primary endpoint (Pinteraction = 0.24) and Kansas City Cardiomyopathy Questionnaire–Total Symptom Score at 12 months (Pinteraction = 0.36) were consistent irrespective of baseline kidney risk category. Participants with higher kidney risk experienced greater reductions in urine albumin-to-creatinine ratio after 6 months (Pinteraction = 0.031), without differences in eGFR slope. Risks of safety events, including hyperkalemia, with finerenone vs placebo were not enhanced among participants with higher kidney risk.
Conclusions
Finerenone appears to consistently improve clinical outcomes, HF-related health status, and albuminuria across a broad spectrum of kidney risk in patients with HF with mildly reduced or preserved ejection fraction. (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure [FINEARTS-HF]; NCT04435626)
{"title":"Finerenone Across the Spectrum of Kidney Risk in Heart Failure","authors":"John W. Ostrominski MD , Finnian R. Mc Causland MBBCh, MMSc , Brian L. Claggett PhD , Akshay S. Desai MD MPH , Pardeep S. Jhund MBChB, MSc, PhD , Carolyn S.P. Lam MD, PhD , Michele Senni MD , Sanjiv J. Shah MD , Adriaan A. Voors MD , Faiez Zannad MD , Bertram Pitt MD , Patrick Schloemer PhD , Meike Brinker MD , Markus F. Scheerer PhD , John J.V. McMurray MD , Scott D. Solomon MD , Muthiah Vaduganathan MD, MPH","doi":"10.1016/j.jchf.2025.03.006","DOIUrl":"10.1016/j.jchf.2025.03.006","url":null,"abstract":"<div><h3>Background</h3><div>Estimated glomerular filtration rate<span> (eGFR) and urine albumin-to-creatinine ratio are complementary domains of kidney disease staging and independently associated with heart failure (HF) progression.</span></div></div><div><h3>Objectives</h3><div><span>The purpose of this study was to evaluate whether the efficacy and safety of finerenone varies according to kidney risk among patients with HF with mildly reduced or preserved </span>ejection fraction.</div></div><div><h3>Methods</h3><div><span>In this prespecified analysis of FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure), clinical outcomes and treatment effects of finerenone on the primary endpoint (cardiovascular death and total [first and recurrent] HF events) and key secondary endpoints were evaluated according to baseline KDIGO (Kidney Disease: Improving Global Outcomes) risk category (low, moderately increased, and high or very high). Key exclusion criteria in FINEARTS-HF were eGFR <25 mL/min/1.73 m</span><sup>2</sup> or serum potassium >5.0 mmol/L.</div></div><div><h3>Results</h3><div>Overall, 5,797 (97%) FINEARTS-HF participants had classifiable KDIGO risk category at baseline, of whom 2,022 (35%), 1,688 (29%), and 2,087 (36%) were low, moderate, and high/very high risk, respectively. Over a median follow-up of 2.7 years, higher kidney risk was associated with a higher rate of primary outcome events, with similar findings for other key endpoints, including the composite kidney outcome, new-onset atrial fibrillation, and vascular events. Benefits of finerenone vs placebo on the primary endpoint (<em>P</em><sub>interaction</sub><span> = 0.24) and Kansas City Cardiomyopathy Questionnaire–Total Symptom Score at 12 months (</span><em>P</em><sub>interaction</sub> = 0.36) were consistent irrespective of baseline kidney risk category. Participants with higher kidney risk experienced greater reductions in urine albumin-to-creatinine ratio after 6 months (<em>P</em><sub>interaction</sub><span> = 0.031), without differences in eGFR slope. Risks of safety events, including hyperkalemia, with finerenone vs placebo were not enhanced among participants with higher kidney risk.</span></div></div><div><h3>Conclusions</h3><div><span><span>Finerenone appears to consistently improve clinical outcomes, HF-related health status, and </span>albuminuria across a broad spectrum of kidney risk in patients with HF with mildly reduced or preserved ejection fraction. (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure [FINEARTS-HF]; </span><span><span>NCT04435626</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"14 1","pages":"Article 102439"},"PeriodicalIF":11.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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