Pub Date : 2025-02-01DOI: 10.1016/j.jchf.2024.10.017
Ozlem Bilen MD, Michael A. Burke MD
{"title":"Asymptomatic But Obstructive","authors":"Ozlem Bilen MD, Michael A. Burke MD","doi":"10.1016/j.jchf.2024.10.017","DOIUrl":"10.1016/j.jchf.2024.10.017","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 344-345"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142965048","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 : 2025-02-01DOI: 10.1016/j.jchf.2024.10.018
Sureya F. Hussani MD , Kelly Nguyen PharmD , Ka man Yu PharmD , Darius Sinha , Amanda R. Vest MBBS, MPH
{"title":"Antiobesity Medications in Patients With Heart Failure","authors":"Sureya F. Hussani MD , Kelly Nguyen PharmD , Ka man Yu PharmD , Darius Sinha , Amanda R. Vest MBBS, MPH","doi":"10.1016/j.jchf.2024.10.018","DOIUrl":"10.1016/j.jchf.2024.10.018","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"13 2","pages":"Pages 375-380"},"PeriodicalIF":10.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142988722","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 : 2025-01-27DOI: 10.1016/j.jchf.2024.11.015
Sergio Raposeiras-Roubin, Francesco Santoro, Luca Arcari, Ravi Vazirani, Giuseppina Novo, Aitor Uribarri, Mariano Enrica, Javier Lopez-Pais, Federico Guerra, Fernando Alfonso, Toni Pätz, Clara Fernandez-Cordon, Roberta Montisci, Miguel Corbi-Pascual, Maria Francesca Marchetti, Manuel Almendro, Luca Cacciotti, Oscar Vedia, Ibrahim El-Battrawy, Emilia Blanco-Ponce, Natale Daniele Brunetti, Ibrahim Akin, Manuel Martinez-Sellés, Holger Thiele, Thomas Stiermaier, Ingo Eitel, Ivan J Nuñez-Gil
Background: Beta-blockers are considered a reasonable therapy for patients with Takotsubo syndrome (TTS), commonly used despite the absence of consistent evidence about its prognosis impact.
Objectives: This study aimed to assess the impact of beta-blocker therapy on long-term mortality and TTS recurrence.
Methods: The authors analyzed 2,853 patients discharged with a confirmed TTS diagnosis, enrolled in the international multicenter GEIST (The GErman Italian Spanish Takotsubo Registry). They performed a propensity score matching analysis to draw up 2 groups of 697 patients paired according to whether or not they received medical therapy with beta-blockers at hospital discharge. The prognostic value of beta-blockers at discharge to predict mortality and TTS recurrence during follow-up was analyzed using Cox regression.
Results: During a mean follow-up of 2.6 years, 485 patients (17.0%) died and 97 (3.4%) have had TTS recurrence. Patients treated with beta-blockers at discharge (n = 2,125) (74.5%) had a lower mortality rate (6.0 vs 8.1 per 100 patients/year). After propensity score matching, the authors found that mortality during follow-up was lower in the beta-blocker group (HR: 0.71; 95% CI: 0.55-0.90). Differences in mortality were especially at the expense of mortality in the first year. No differences were found by subgroups. Moreover, beta-blocker therapy was not associated with lower TTS recurrence during the follow-up (HR: 0.74, 95% CI: 0.61-1.89). No association between the use of beta-blockers at discharge and left ventricle ejection fraction recovery has also been observed.
Conclusions: Beta-blocker therapy in patients with TTS is associated with lower follow-up mortality, but not with lower TTS recurrence. (The GErman Italian Spanish Takotsubo Registry [GEIST]; NCT04361994).
{"title":"Beta-Blockers and Long-Term Mortality in Takotsubo Syndrome: Results of the Multicenter GEIST Registry.","authors":"Sergio Raposeiras-Roubin, Francesco Santoro, Luca Arcari, Ravi Vazirani, Giuseppina Novo, Aitor Uribarri, Mariano Enrica, Javier Lopez-Pais, Federico Guerra, Fernando Alfonso, Toni Pätz, Clara Fernandez-Cordon, Roberta Montisci, Miguel Corbi-Pascual, Maria Francesca Marchetti, Manuel Almendro, Luca Cacciotti, Oscar Vedia, Ibrahim El-Battrawy, Emilia Blanco-Ponce, Natale Daniele Brunetti, Ibrahim Akin, Manuel Martinez-Sellés, Holger Thiele, Thomas Stiermaier, Ingo Eitel, Ivan J Nuñez-Gil","doi":"10.1016/j.jchf.2024.11.015","DOIUrl":"https://doi.org/10.1016/j.jchf.2024.11.015","url":null,"abstract":"<p><strong>Background: </strong>Beta-blockers are considered a reasonable therapy for patients with Takotsubo syndrome (TTS), commonly used despite the absence of consistent evidence about its prognosis impact.</p><p><strong>Objectives: </strong>This study aimed to assess the impact of beta-blocker therapy on long-term mortality and TTS recurrence.</p><p><strong>Methods: </strong>The authors analyzed 2,853 patients discharged with a confirmed TTS diagnosis, enrolled in the international multicenter GEIST (The GErman Italian Spanish Takotsubo Registry). They performed a propensity score matching analysis to draw up 2 groups of 697 patients paired according to whether or not they received medical therapy with beta-blockers at hospital discharge. The prognostic value of beta-blockers at discharge to predict mortality and TTS recurrence during follow-up was analyzed using Cox regression.</p><p><strong>Results: </strong>During a mean follow-up of 2.6 years, 485 patients (17.0%) died and 97 (3.4%) have had TTS recurrence. Patients treated with beta-blockers at discharge (n = 2,125) (74.5%) had a lower mortality rate (6.0 vs 8.1 per 100 patients/year). After propensity score matching, the authors found that mortality during follow-up was lower in the beta-blocker group (HR: 0.71; 95% CI: 0.55-0.90). Differences in mortality were especially at the expense of mortality in the first year. No differences were found by subgroups. Moreover, beta-blocker therapy was not associated with lower TTS recurrence during the follow-up (HR: 0.74, 95% CI: 0.61-1.89). No association between the use of beta-blockers at discharge and left ventricle ejection fraction recovery has also been observed.</p><p><strong>Conclusions: </strong>Beta-blocker therapy in patients with TTS is associated with lower follow-up mortality, but not with lower TTS recurrence. (The GErman Italian Spanish Takotsubo Registry [GEIST]; NCT04361994).</p>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364879","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 : 2025-01-22DOI: 10.1016/j.jchf.2024.11.003
Antonio Cannata, Amitai Segev, Cristina Madaudo, Emanuele Bobbio, Chiara Baggio, Jonathan Schütze, Piero Gentile, Marta Sanguineti, Luca Monzo, Matteo Schettino, Emma Ferone, Ahmed Elsanhoury, Anan Younis, Matteo Palazzini, Adriana Ferroni, Valentina Giani, Matthew Sadler, Daniela Di Lisi, Mohammad Albarjas, Leonardo Calò, Daniel Sado, Christian Lars Polte, Andrea Garascia, Paul A Scott, Ajay M Shah, Mauro Giacca, Gianfranco Sinagra, Entela Bollano, Theresa McDonagh, Carsten Tschöpe, Giuseppina Novo, Enrico Ammirati, Roy Beigel, Christoph Gräni, Marco Merlo, Pietro Ameri, Daniel I Bromage
Background: Neutrophil-to-lymphocyte ratio (NLR) is an easy-to-use inflammatory biomarker. Baseline NLR is independently associated with incident cardiovascular events and all-cause mortality. However, whether this applies to acute myocarditis (AM) has not been evaluated.
Objectives: The present study aimed to investigate the prognostic value of NLR in patients with AM.
Methods: A total of 1,150 consecutive patients with a diagnosis of AM admitted to 10 international tertiary referral cardiac centers were included in the study. The diagnosis was confirmed using cardiac magnetic resonance or endomyocardial biopsy. The primary outcome measure was a composite of all-cause mortality or heart transplantation. Patients were divided into 2 groups according to an NLR cutoff of 4 derived from spline regression analysis and 70:30 train-test split algorithm.
Results: Patients with an NLR <4 were younger and more likely to present with chest pain, and those with an NLR ≥4 were more likely to present with breathlessness and have other comorbidities. Over a median follow-up of 228 weeks, a NLR ≥4 was associated with a worse prognosis (P < 0.0001). After adjustment for prognostic variables, NLR emerged as an independent predictor of outcome (HR: 3.03 [95% CI: 1.30-7.04]; P = 0.010). Elevated NLR remained associated with worse outcomes among patients with preserved ejection fraction at baseline, who are conventionally considered to be at lower risk of adverse events (P < 0.0001).
Conclusions: In patients with AM, elevated NLR is associated with worse prognosis and may be valuable for stratifying patients, even those conventionally considered at low risk.
{"title":"Elevated Neutrophil-to-Lymphocyte Ratio Predicts Prognosis in Acute Myocarditis.","authors":"Antonio Cannata, Amitai Segev, Cristina Madaudo, Emanuele Bobbio, Chiara Baggio, Jonathan Schütze, Piero Gentile, Marta Sanguineti, Luca Monzo, Matteo Schettino, Emma Ferone, Ahmed Elsanhoury, Anan Younis, Matteo Palazzini, Adriana Ferroni, Valentina Giani, Matthew Sadler, Daniela Di Lisi, Mohammad Albarjas, Leonardo Calò, Daniel Sado, Christian Lars Polte, Andrea Garascia, Paul A Scott, Ajay M Shah, Mauro Giacca, Gianfranco Sinagra, Entela Bollano, Theresa McDonagh, Carsten Tschöpe, Giuseppina Novo, Enrico Ammirati, Roy Beigel, Christoph Gräni, Marco Merlo, Pietro Ameri, Daniel I Bromage","doi":"10.1016/j.jchf.2024.11.003","DOIUrl":"10.1016/j.jchf.2024.11.003","url":null,"abstract":"<p><strong>Background: </strong>Neutrophil-to-lymphocyte ratio (NLR) is an easy-to-use inflammatory biomarker. Baseline NLR is independently associated with incident cardiovascular events and all-cause mortality. However, whether this applies to acute myocarditis (AM) has not been evaluated.</p><p><strong>Objectives: </strong>The present study aimed to investigate the prognostic value of NLR in patients with AM.</p><p><strong>Methods: </strong>A total of 1,150 consecutive patients with a diagnosis of AM admitted to 10 international tertiary referral cardiac centers were included in the study. The diagnosis was confirmed using cardiac magnetic resonance or endomyocardial biopsy. The primary outcome measure was a composite of all-cause mortality or heart transplantation. Patients were divided into 2 groups according to an NLR cutoff of 4 derived from spline regression analysis and 70:30 train-test split algorithm.</p><p><strong>Results: </strong>Patients with an NLR <4 were younger and more likely to present with chest pain, and those with an NLR ≥4 were more likely to present with breathlessness and have other comorbidities. Over a median follow-up of 228 weeks, a NLR ≥4 was associated with a worse prognosis (P < 0.0001). After adjustment for prognostic variables, NLR emerged as an independent predictor of outcome (HR: 3.03 [95% CI: 1.30-7.04]; P = 0.010). Elevated NLR remained associated with worse outcomes among patients with preserved ejection fraction at baseline, who are conventionally considered to be at lower risk of adverse events (P < 0.0001).</p><p><strong>Conclusions: </strong>In patients with AM, elevated NLR is associated with worse prognosis and may be valuable for stratifying patients, even those conventionally considered at low risk.</p>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023513","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}
Background: Acute decompensated heart failure (ADHF) leads to hospitalizations and functional decline in older adults. Although cardiac rehabilitation (CR) is effective for stable heart failure, its impact on ADHF patients, particularly those without frailty, is unclear.
Objectives: The goal of this study was to evaluate the efficacy and safety of early in-hospital CR for patients hospitalized with ADHF who are not frail.
Methods: In this multicenter trial (ACTIVE-ADHF [Effects of Acute Phase Intensive Exercise Training in Patients with Acute Decompensated Heart Failure]), ADHF patients without physical frailty were randomized 2:1 to undergo either exercise-based CR or standard care. The intervention included early mobilization and structured exercise training. The primary outcome was the change in 6-minute walk distance (6MWD) from baseline to discharge. Secondary outcomes assessed physical and cognitive function, quality of life, and safety.
Results: A total of 91 patients were randomized to treatment, with 59 allocated to the intervention group and 32 to the control group. The primary outcome, 6MWD, improved significantly more in the intervention group, with a mean increase of 75.0 ± 7.8 m vs 44.1 ± 10.2 m in the control group, with an effect size of 30.9 ± 13.1 m (95% CI: 4.8-57.0; P = 0.021). The intervention group showed favorable results in secondary efficacy outcomes, including physical and cognitive function, physical activity, and quality of life. Safety outcomes were similar between groups, except for a greater reduction in B-type natriuretic peptide levels at 90 days' postdischarge in the intervention group.
Conclusions: In patients with ADHF without physical frailty, in-hospital exercise-based CR led to significant improvements in 6MWD at 2 weeks after randomization without compromising safety. (ACTIVE-ADHF [Effects of Acute Phase Intensive Exercise Training in Patients with Acute Decompensated Heart Failure]; UMIN000020919).
{"title":"Effects of Acute Phase Intensive Exercise Training in Patients With Acute Decompensated Heart Failure.","authors":"Kentaro Kamiya, Shinya Tanaka, Hiroshi Saito, Masashi Yamashita, Ryusuke Yonezawa, Nobuaki Hamazaki, Ryota Matsuzawa, Kohei Nozaki, Yoshiko Endo, Kazuki Wakaume, Shota Uchida, Emi Maekawa, Yuya Matsue, Makoto Suzuki, Takayuki Inomata, Junya Ako","doi":"10.1016/j.jchf.2024.11.006","DOIUrl":"10.1016/j.jchf.2024.11.006","url":null,"abstract":"<p><strong>Background: </strong>Acute decompensated heart failure (ADHF) leads to hospitalizations and functional decline in older adults. Although cardiac rehabilitation (CR) is effective for stable heart failure, its impact on ADHF patients, particularly those without frailty, is unclear.</p><p><strong>Objectives: </strong>The goal of this study was to evaluate the efficacy and safety of early in-hospital CR for patients hospitalized with ADHF who are not frail.</p><p><strong>Methods: </strong>In this multicenter trial (ACTIVE-ADHF [Effects of Acute Phase Intensive Exercise Training in Patients with Acute Decompensated Heart Failure]), ADHF patients without physical frailty were randomized 2:1 to undergo either exercise-based CR or standard care. The intervention included early mobilization and structured exercise training. The primary outcome was the change in 6-minute walk distance (6MWD) from baseline to discharge. Secondary outcomes assessed physical and cognitive function, quality of life, and safety.</p><p><strong>Results: </strong>A total of 91 patients were randomized to treatment, with 59 allocated to the intervention group and 32 to the control group. The primary outcome, 6MWD, improved significantly more in the intervention group, with a mean increase of 75.0 ± 7.8 m vs 44.1 ± 10.2 m in the control group, with an effect size of 30.9 ± 13.1 m (95% CI: 4.8-57.0; P = 0.021). The intervention group showed favorable results in secondary efficacy outcomes, including physical and cognitive function, physical activity, and quality of life. Safety outcomes were similar between groups, except for a greater reduction in B-type natriuretic peptide levels at 90 days' postdischarge in the intervention group.</p><p><strong>Conclusions: </strong>In patients with ADHF without physical frailty, in-hospital exercise-based CR led to significant improvements in 6MWD at 2 weeks after randomization without compromising safety. (ACTIVE-ADHF [Effects of Acute Phase Intensive Exercise Training in Patients with Acute Decompensated Heart Failure]; UMIN000020919).</p>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023511","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 : 2025-01-21DOI: 10.1016/j.jchf.2024.10.024
Vinayak Subramanian, Traci Betts, Matthew W Segar, Lajjaben Patel, Neil Keshvani, Alvin Chandra, Ambarish Pandey
{"title":"m-Health Based Cardiac Rehabilitation Program for Management of Older Patients With HFpEF: A Pilot RCT.","authors":"Vinayak Subramanian, Traci Betts, Matthew W Segar, Lajjaben Patel, Neil Keshvani, Alvin Chandra, Ambarish Pandey","doi":"10.1016/j.jchf.2024.10.024","DOIUrl":"https://doi.org/10.1016/j.jchf.2024.10.024","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364348","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 : 2025-01-17DOI: 10.1016/j.jchf.2024.10.021
Peter Carson, John R Teerlink, Michel Komajda, Inder Anand, Milton Packer, Javed Butler, Wolfram Doehner, João Pedro Ferreira, Gerasimos Filippatos, Markus Haass, Alan Miller, Steen Pehrson, Stuart J Pocock, Tomoko Iwata, Martina Brueckmann, Tomasz Gasior, Faiez Zannad, Stefan D Anker
Background: There is limited published information on outcome adjudication in heart failure (HF) trials, particularly in heart failure with preserved ejection fraction (HFpEF).
Objectives: The study sought to compare investigator reports with clinical events committee (CEC) adjudication and assess the impact of the SCTI (Standardized Data Collection for Cardiovascular Trials) criteria.
Methods: In the EMPEROR-Preserved (EMPagliflozin outcome tRial in Patients with chronic heart Failure With Preserved Ejection Fraction) trial, we compared investigator reports with CEC for concordance, treatment effect on primary composite outcome events and components (first event primary heart failure hospitalization [HHF] or cardiovascular [CV] mortality), prognosis after first HHF, total HHF, and trial duration with and without SCTI criteria.
Results: The CEC confirmed 67.4% investigator-reported events for the primary outcome (CV mortality 82.7%, HHF 66.3%). The HR for treatment effect did not differ between adjudication methods for the primary outcome: investigator reports (HR: 0.77; 95% CI: 0.69-0.87), CEC (HR: 0.79; 95% CI: 0.69-0.90), its components, or total HHFs. The prognosis after the first HHF for all-cause mortality and CV mortality also did not differ between investigator reports and the CEC, nor did investigator reports and HHFs with a different CEC cause. SCTI criteria were present in 92% of CEC HHFs with a similar treatment effect to non-SCTI criteria. The investigator-reported primary events reached the protocol target number 6 months earlier than the CEC (7 months with full SCTI criteria).
Conclusions: Investigator adjudication is an alternative to a CEC with similar accuracy and faster event accumulation in HFpEF. The use of granular (SCTI) criteria did not improve trial performance. Our data suggest that a broader definition of an HHF event could be particularly beneficial in HFpEF clinical trials. (EMPagliflozin outcome tRial in Patients with chronic heart Failure With Preserved Ejection Fraction; NCT03057951).
{"title":"Comparison of Investigator-Reported and Centrally Adjudicated Heart Failure Outcomes in the EMPEROR-Preserved Trial.","authors":"Peter Carson, John R Teerlink, Michel Komajda, Inder Anand, Milton Packer, Javed Butler, Wolfram Doehner, João Pedro Ferreira, Gerasimos Filippatos, Markus Haass, Alan Miller, Steen Pehrson, Stuart J Pocock, Tomoko Iwata, Martina Brueckmann, Tomasz Gasior, Faiez Zannad, Stefan D Anker","doi":"10.1016/j.jchf.2024.10.021","DOIUrl":"https://doi.org/10.1016/j.jchf.2024.10.021","url":null,"abstract":"<p><strong>Background: </strong>There is limited published information on outcome adjudication in heart failure (HF) trials, particularly in heart failure with preserved ejection fraction (HFpEF).</p><p><strong>Objectives: </strong>The study sought to compare investigator reports with clinical events committee (CEC) adjudication and assess the impact of the SCTI (Standardized Data Collection for Cardiovascular Trials) criteria.</p><p><strong>Methods: </strong>In the EMPEROR-Preserved (EMPagliflozin outcome tRial in Patients with chronic heart Failure With Preserved Ejection Fraction) trial, we compared investigator reports with CEC for concordance, treatment effect on primary composite outcome events and components (first event primary heart failure hospitalization [HHF] or cardiovascular [CV] mortality), prognosis after first HHF, total HHF, and trial duration with and without SCTI criteria.</p><p><strong>Results: </strong>The CEC confirmed 67.4% investigator-reported events for the primary outcome (CV mortality 82.7%, HHF 66.3%). The HR for treatment effect did not differ between adjudication methods for the primary outcome: investigator reports (HR: 0.77; 95% CI: 0.69-0.87), CEC (HR: 0.79; 95% CI: 0.69-0.90), its components, or total HHFs. The prognosis after the first HHF for all-cause mortality and CV mortality also did not differ between investigator reports and the CEC, nor did investigator reports and HHFs with a different CEC cause. SCTI criteria were present in 92% of CEC HHFs with a similar treatment effect to non-SCTI criteria. The investigator-reported primary events reached the protocol target number 6 months earlier than the CEC (7 months with full SCTI criteria).</p><p><strong>Conclusions: </strong>Investigator adjudication is an alternative to a CEC with similar accuracy and faster event accumulation in HFpEF. The use of granular (SCTI) criteria did not improve trial performance. Our data suggest that a broader definition of an HHF event could be particularly beneficial in HFpEF clinical trials. (EMPagliflozin outcome tRial in Patients with chronic heart Failure With Preserved Ejection Fraction; NCT03057951).</p>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080109","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 : 2025-01-17DOI: 10.1016/j.jchf.2024.09.024
Cristine Schmidt, Sandra Magalhães, Priscilla Gois Basilio, Cláudio Santos, Maria Isilda Oliveira, João Pedro Ferreira, Fernando Ribeiro, Mário Santos
Background: Despite being an evidence-based intervention, the implementation of cardiac rehabilitation (CR) is often unsatisfactory, especially among patients with heart failure (HF). Home-based CR can serve as an alternative to improve accessibility for patients unable to participate in center-based programs.
Objectives: The study sought to compare the clinical impact of center- vs home-based CR in HF patients.
Methods: Single-center, parallel group, noninferiority trial, enrolling HF patients irrespective of ejection fraction. Patients were randomly allocated in a 1:1 ratio, then adjusted to a 1 center/2 home ratio during the COVID-19 pandemic, then adjusted to 12 weeks of a standard center-based (24 supervised exercise sessions) or home-based CR (4 supervised sessions plus 20 sessions at home, asynchronously monitored by telephone using wearable smartwatch data) program. The primary outcome was change in peak oxygen uptake (Vo2peak) at 12 weeks.
Results: Of the 120 patients (age 62 ± 11 years, 66% men, mean left ventricular ejection fraction 36 ± 11%) who were randomized to center-based (n = 45) or home-based (n = 75) CR, 95 (79%) had complete Vo2peak data at the 12-week assessment: 34 (76%) in the center-based group and 61 (81%) in the home-based group. No significant between-group differences were found in Vo2peak change from baseline to week 12 (0.8 mL/kg/min [95% CI: 1.8 to -0.16 mL/kg/min]; P = 0.10). Additionally, no between-group differences were found for changes in the prespecified secondary outcomes: 6-minute walking distance, Minnesota Living with Heart Failure Questionnaire scores, disease-related biomarkers, and physical fitness. Exercise adherence to the CR program was similar between groups (home-based 84% vs center-based 81%).
Conclusions: In a contemporary well-treated HF population, home-based CR was noninferior to the center-based program, supporting the home-based approach as an effective and feasible alternative to the traditional center-based programs. (EXercise InTervention in Heart Failure [EXIT-HF]; NCT04334603).
{"title":"Center- vs Home-Based Cardiac Rehabilitation in Patients With Heart Failure: EXIT-HF Randomized Controlled Trial.","authors":"Cristine Schmidt, Sandra Magalhães, Priscilla Gois Basilio, Cláudio Santos, Maria Isilda Oliveira, João Pedro Ferreira, Fernando Ribeiro, Mário Santos","doi":"10.1016/j.jchf.2024.09.024","DOIUrl":"https://doi.org/10.1016/j.jchf.2024.09.024","url":null,"abstract":"<p><strong>Background: </strong>Despite being an evidence-based intervention, the implementation of cardiac rehabilitation (CR) is often unsatisfactory, especially among patients with heart failure (HF). Home-based CR can serve as an alternative to improve accessibility for patients unable to participate in center-based programs.</p><p><strong>Objectives: </strong>The study sought to compare the clinical impact of center- vs home-based CR in HF patients.</p><p><strong>Methods: </strong>Single-center, parallel group, noninferiority trial, enrolling HF patients irrespective of ejection fraction. Patients were randomly allocated in a 1:1 ratio, then adjusted to a 1 center/2 home ratio during the COVID-19 pandemic, then adjusted to 12 weeks of a standard center-based (24 supervised exercise sessions) or home-based CR (4 supervised sessions plus 20 sessions at home, asynchronously monitored by telephone using wearable smartwatch data) program. The primary outcome was change in peak oxygen uptake (Vo<sub>2</sub>peak) at 12 weeks.</p><p><strong>Results: </strong>Of the 120 patients (age 62 ± 11 years, 66% men, mean left ventricular ejection fraction 36 ± 11%) who were randomized to center-based (n = 45) or home-based (n = 75) CR, 95 (79%) had complete Vo<sub>2</sub>peak data at the 12-week assessment: 34 (76%) in the center-based group and 61 (81%) in the home-based group. No significant between-group differences were found in Vo<sub>2</sub>peak change from baseline to week 12 (0.8 mL/kg/min [95% CI: 1.8 to -0.16 mL/kg/min]; P = 0.10). Additionally, no between-group differences were found for changes in the prespecified secondary outcomes: 6-minute walking distance, Minnesota Living with Heart Failure Questionnaire scores, disease-related biomarkers, and physical fitness. Exercise adherence to the CR program was similar between groups (home-based 84% vs center-based 81%).</p><p><strong>Conclusions: </strong>In a contemporary well-treated HF population, home-based CR was noninferior to the center-based program, supporting the home-based approach as an effective and feasible alternative to the traditional center-based programs. (EXercise InTervention in Heart Failure [EXIT-HF]; NCT04334603).</p>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080107","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}