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  • 2区Q2影响因子: 4.1
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    1. Prevalence and prognostic significance of malnutrition in diabetic patients with coronary artery disease: a cohort study.
    1. 糖尿病患者营养不良的患病率和预后意义与冠状动脉疾病:一项队列研究。
    作者:Wei Wen , Zhang Lingyu , Li Guode , Huang Zhidong , Liu Jin , Wu Zhihuang , Wu Yuanying , Lin Jinrong , Zhang Yunhan , Yu Yaren , Huang Haozhang , Li Qiang , Wang Bo , Liu Yong , Tu Mei , Chen Hong , Chen Shiqun
    期刊:Nutrition & metabolism
    日期:2021-11-27
    DOI :10.1186/s12986-021-00626-4
    BACKGROUND:Malnutrition is associated with poor prognosis in cardiovascular disease patients or in diabetic patients. However, the relationship between malnutrition and clinical outcomes in diabetic patients with coronary artery disease (CAD) is not well known. The aim of this study is to report the prevalence and prognostic consequences of malnutrition in diabetic patients with CAD. METHODS:In this retrospective observational study, the Controlling Nutritional Status (CONUT) score applied to 12,898 consecutive diabetic patients with CAD. The association between malnutrition and long-term all-cause mortality was examined using Cox proportional hazards regression analysis. RESULTS:According to CONUT score, 60.5% patients suffered from malnutrition; 46.4%, 13.2%, and 0.9% patients had mild, moderate, and severe malnutrition, respectively. During a median follow-up of 4.88 (2.83-7.51) years, 1973 (15.3%) patients died. After adjustment for confounders, malnutrition was associated with significantly increased risk for long-term all-cause mortality (adjusted hazard ratio for mild malnutrition and moderate to severe malnutrition, respectively: 1.38 [95% confidence interval (CI) 1.07-1.77]; P value = 0.012 and 1.63 [95% CI 1.18-2.24]; P value = 0.003). A similar association was observed around subgroups. CONCLUSIONS:Malnutrition is common in diabetic patients with CAD and is strongly associated with increased mortality. It is necessary to adequately assess the nutritional status and take the effective nutritional guidance to improve the prognosis of diabetic patients with CAD.
  • 4区Q3影响因子: 1.5
    2. Combined effect of nutritional status on long-term outcomes in patients with coronary artery disease undergoing percutaneous coronary intervention.
    2. 对长期结果患者的冠状动脉疾病经皮冠状动脉介入的营养状况的综合作用。
    作者:Wada Hideki , Dohi Tomotaka , Miyauchi Katsumi , Endo Hirohisa , Tsuboi Shuta , Ogita Manabu , Kasai Takatoshi , Okazaki Shinya , Isoda Kikuo , Suwa Satoru , Daida Hiroyuki
    期刊:Heart and vessels
    日期:2018-06-08
    DOI :10.1007/s00380-018-1201-x
    Previous studies have reported the prognostic value of objective nutritional indices such as the Controlling Nutritional Status (CONUT) score, Geriatric Nutritional Risk Index (GNRI) and Prognostic Nutritional Index (PNI). However, the effects of these indices in patients with coronary artery disease (CAD) who have undergone percutaneous coronary intervention (PCI) remain unclear. Furthermore, there are insufficient data to combine these indices. A total of 1984 patients who underwent elective PCI were enrolled. The Combined Objective Nutritional Score was determined by assigning 1 point each for high CONUT score (3-12), low GNRI (< 98) or low PNI (< 45). Patients were grouped into normal nutritional status (0 points), mild-to-moderate malnutrition (1-2 points) and severe malnutrition (3 points). Incidences of all-cause death and cardiac death were evaluated. Among the 1984 patients, 514 (25.9%) and 244 (12.3%) had mild-to-moderate and severe malnutrition, respectively. During follow-up (median 7.4 years), 293 all-cause deaths were identified, including 92 cardiac deaths. Kaplan-Meier curves showed ongoing divergence in rates of death among nutritional statuses determined by the novel score (log rank test, p < 0.0001). Multivariate Cox hazard analysis showed that patients with a Combined Objective Nutritional Score of 3 showed 2.91-fold (95% confidence interval (CI) 2.10-4.00; p < 0.0001) and 2.16-fold (95% CI 1.15-3.92; p = 0.02) increases in risk of mortality and cardiac mortality compared with patients with a Combined Objective Nutritional Score of 0. In conclusion, malnutrition as evaluated by the Combined Objective Nutritional Score was significantly associated with worse long-term cardiovascular outcomes among CAD patients who underwent PCI.
  • 2区Q1影响因子: 3.7
    3. Prognostic impact of nutritional status assessed by the Controlling Nutritional Status score in patients with stable coronary artery disease undergoing percutaneous coronary intervention.
    3. 通过在稳定患者冠状动脉疾病经皮冠状动脉介入的控制营养状况打分来评价营养状况预后的影响。
    作者:Wada Hideki , Dohi Tomotaka , Miyauchi Katsumi , Doi Shinichiro , Konishi Hirokazu , Naito Ryo , Tsuboi Shuta , Ogita Manabu , Kasai Takatoshi , Okazaki Shinya , Isoda Kikuo , Suwa Satoru , Daida Hiroyuki
    期刊:Clinical research in cardiology : official journal of the German Cardiac Society
    日期:2017-06-20
    DOI :10.1007/s00392-017-1132-z
    BACKGROUND:Recently, malnutrition has been shown to be related to worse clinical outcomes in patients with heart failure. However, the association between nutritional status and clinical outcomes in patients with coronary artery disease (CAD) remains unclear. We investigated the prognostic value of malnutrition assessed by the Controlling Nutritional Status (CONUT; range 0-12, higher = worse, consisting of serum albumin, cholesterol and lymphocytes) score in patients with CAD. METHODS:The CONUT score was measured on admission in a total of 1987 patients with stable CAD who underwent elective percutaneous coronary intervention (PCI) between 2000 and 2011. Patients were divided into two groups according to their CONUT score (0-1 vs. ≥2). The incidence of major adverse cardiac events (MACE), including all-cause death and non-fatal myocardial infarction, was evaluated. RESULTS:The median CONUT score was 1 (interquartile range 0-2). During the median follow-up of 7.4 years, 342 MACE occurred (17.2%). Kaplan-Meier curves revealed that patients with high CONUT scores had higher rates of MACE (log-rank p < 0.0001). High CONUT scores showed a significant increase in the incidence of MACE compared with low CONUT scores, even after adjusting for confounding factors (hazard ratio: 1.64, 95% confidence interval 1.30-2.07, p < 0.0001). Adding CONUT scores to a baseline model with established risk factors improved the C-index (p = 0.02), net reclassification improvement (p = 0.004) and integrated discrimination improvement (p = 0.0003). CONCLUSIONS:Nutritional status assessed by the CONUT score was significantly associated with long-term clinical outcomes in patients with CAD. Pre-PCI assessment of the CONUT score may provide useful prognostic information.
  • 3区Q2影响因子: 3
    4. Associations between depression, nutrition, and outcomes among individuals with coronary artery disease.
    4. 冠心病患者抑郁、营养和预后之间的关系。
    作者:Wang Haochen , Liu Fengyao , Ma Huan , Yin Han , Wang Ping , Bai Bingqing , Guo Lan , Geng Qingshan
    期刊:Nutrition (Burbank, Los Angeles County, Calif.)
    日期:2021-01-14
    DOI :10.1016/j.nut.2021.111157
    OBJECTIVES:Depression and malnutrition are prevalent among people with coronary artery disease (CAD) and can affect their prognosis, but the relationship between depression and malnutrition and its co-effect on prognosis is not clear. We sought to explore that relationship and its effects. METHODS:In this study, the nutritional and emotional statuses of 547 people with CAD were assessed using the Controlling Nutritional Status (CONUT) score and the Patient Health Questionnaire-9. The average follow-up period was 2.1 y, after which we explored the relationship between depression and nutrition and prognosis. RESULTS:A total of 41% of the participants were found to have mild malnutrition, 10% moderate to severe malnutrition, 26% had mild depression, and 11% had moderate to severe depression. A total of 20.6% of the participants were found to have comorbidities of depression and malnutrition; and both moderate to severe depression (adjusted hazard ratio [HR], 1.674; 95% confidence interval [CI], 1.098-2.551) and moderate to severe malnutrition (adjusted HR, 1.686; 95% CI, 1.073-2.648) were observed to be risk factors for the composite end point. Participants with comorbidities of depression and malnutrition were found to have increased risk of cardiovascular death (HR, 5.390; 95% CI, 1.483-19.589) and composite end point (adjusted HR, 1.791; 95% CI, 1.133-2.833) compared to those without both depression and malnutrition. CONCLUSIONS:Depression and malnutrition were found to be risk factors for adverse outcomes in people with CAD. People with CAD should pay attention to their emotional and nutritional statuses, and interventions must be timely and efficient.
  • 4区Q2影响因子: 1.3
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    5. The predictive ability of Controlling Nutritional Status score on in-hospital mortality in patients admitted to coronary care unit.
    5. 控制营养状况评分对冠心病监护病房住院患者住院死亡率的预测能力。
    期刊:Revista da Associacao Medica Brasileira (1992)
    日期:2024-12-02
    DOI :10.1590/1806-9282.20240958
    OBJECTIVE:Controlling Nutritional Status score was previously described and has been used in predicting short- and long-term outcomes in different patient populations. The aim of this study was to test the relationship between Controlling Nutritional Status score and in-hospital mortality in coronary care unit patients (MORCOR-TURK population). METHODS:In this multicenter and national study, all patients with an available Controlling Nutritional Status score were included in the analysis. The Controlling Nutritional Status score was calculated according to previously described criteria. To be able to understand the significance of the Controlling Nutritional Status score, we constructed two models. Model 1 included age, heart failure, chronic kidney disease, hypertension, diabetes mellitus, and coronary artery disease history. Model 2 included the Controlling Nutritional Status score and Model 1. We then statistically compared the performances of the two models. RESULTS:A total of 1,018 patients with known Controlling Nutritional Status scores were included in the analysis. Demographic characteristics are shown. In Model 1, the -2 log-likelihood ratio was 395.995, Nagelkerke R2 was 0.133, and area under the curve was 0.739 (95%CI 0.67-0.81). In the second model to which the Controlling Nutritional Status score is added (Model 2), the -2 log-likelihood ratio was 373.743, Nagelkerke R2 was 0.191, and area under the curve was 0.787 (95%CI 0.72-0.85). The area under the curve value of Model 2 was statistically higher than Model 1 (DeLong p-value: 0.01). A statistically significant correlation was found between death and Controlling Nutritional Status score in Model 2 [OR 1.347 (1.193-1.521), p<0.001]. CONCLUSIONS:Our study showed that the Controlling Nutritional Status score may be a significant predictor of in-hospital mortality in coronary care unit patients.
  • 4区Q4影响因子: 0.6
    6. Impact of Controlling Nutritional Status Score (CONUT) and Prognostic Nutritional Index (PIN) on Patients Undergoing Coronary Artery Bypass Graft Surgery.
    6. 控制营养状况评分(CONUT)和预后营养指数(PIN)的患者接受冠状动脉旁路移植术的影响。
    作者:Teker Açıkel Melike Elif , Korkut Ali Kubilay
    期刊:The heart surgery forum
    日期:2019-07-25
    DOI :10.1532/hsf.2493
    BACKGROUND:The aim of this study is to evaluate the negative effect of malnutrition in patients with coronary artery disease who are undergoing coronary artery bypass graft surgery. METHODS:In this study, we analyzed 149 patients, who underwent coronary artery bypass surgery. Nutritional status of the patients was classified using controlling nutritional status score (CONUT) and prognostic nutritional index (PNI). Statistical correlation between malnutrition and complication following operation was evaluated with the chi-square test. Statistical alpha significant level was accepted P < 0.05. RESULTS:There were various complications in 38 patients. Renal failure was the predominant problem in 18 of them. There was statistical significance between malnutrition and complication (P < .001). There were more complications in the controlling nutritional status score and prognostic nutritional index groups. Renal complication (P < .001), hemorrhage (P < .05), and mortality (P < .05) were high in the severe controlling nutritional status score and prognostic nutritional index groups. CONCLUSION:There are manifest correlations between the severe controlling nutritional status score and prognostic nutritional index groups and morbidity and mortality after coronary artery bypass graft surgery. We found that renal complications, hemorrhage, and mortality rate.
  • 2区Q1影响因子: 5
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    7. Association between Preoperative Nutritional Status and Clinical Outcomes of Patients with Coronary Artery Disease Undergoing Percutaneous Coronary Intervention.
    7. 经皮冠状动脉介入冠状动脉疾病患者术前营养状况及临床结果的关系。
    作者:Chen Su-Chan , Yang Ya-Ling , Wu Cheng-Hsueh , Huang Shao-Sung , Chan Wan Leong , Lin Shing-Jong , Chou Chia-Yu , Chen Jaw-Wen , Pan Ju-Pin , Charng Min-Ji , Chen Ying-Hwa , Wu Tao-Cheng , Lu Tse-Min , Hsu Pai-Feng , Huang Po-Hsun , Cheng Hao-Min , Huang Chin-Chou , Sung Shih-Hsien , Lin Yenn-Jiang , Leu Hsin-Bang
    期刊:Nutrients
    日期:2020-05-02
    DOI :10.3390/nu12051295
    BACKGROUND:Malnutrition is associated with poor outcomes in patients with cancer, heart failure and chronic kidney disease. This study aimed to investigate the predictive value of the Controlling Nutritional Status (CONUT) score in coronary artery disease (CAD) patients. METHODS:We recruited a cohort of 3118 patients with CAD undergoing percutaneous coronary intervention (PCI) from 2005 to 2015. Nutritional status was evaluated using the CONUT score, with higher scores reflecting worse nutritional status. RESULTS:After adjustment for comorbidities and medication, an increased CONUT score was independently associated with a higher risk of acute myocardial infarction (AMI) (HR: 1.13; 95% CI: 1.03-1.24), cardiovascular (CV) death (HR: 1.18; 95% CI: 1.07-1.30), congestive heart failure (CHF) (HR: 1.11; 95% CI: 1.04-1.18), a major adverse cardiovascular event (MACE) (HR: 1.14; 95% CI: 1.07-1.22), and total CV events (HR: 1.11; 95% CI: 1.07-1.15). The subgroup analyses demonstrated that the association of the CONUT score existed independently of other established cardiovascular risk factors. In addition, CONUT significantly improved risk stratification for myocardial infarction (MI), cardiac death, CHF, MACEs and total CV events compared to conventional risk factors in CAD patients by the significant increase in the C-index (p < 0.05) and reclassification risk categories in cardiac death and MACEs. Conclusions The CONUT score improved the risk prediction of adverse events compared to traditional risk factors in CAD patients after percutaneous coronary intervention (PCI).
  • 2区Q1影响因子: 5.1
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    8. Prevalence and prognostic value of malnutrition in patients with acute coronary syndrome and chronic kidney disease.
    8. 营养不良的患病率和预后价值急性冠脉综合征和慢性肾脏疾病患者。
    期刊:Frontiers in nutrition
    日期:2023-07-14
    DOI :10.3389/fnut.2023.1187672
    Background:Malnutrition is a rising global health issue associated with unfavorable outcomes of a variety of disorders. Currently, the prevalence and prognostic significance of malnutrition to patients with acute coronary syndrome (ACS) and chronic kidney disease (CKD) remained largely unclear. Methods:A total of 705 patients diagnosed with ACS and CKD in the First Affiliated Hospital of Wenzhou Medical University between 2013 and 2021 were included in this retrospective cohort study. Malnutrition was assessed by the Controlling Nutritional Status (CONUT), the Geriatric Nutritional Risk Index (GNRI), and the Prognostic Nutritional Index (PNI), respectively. The relationships between malnutrition and all-cause mortality and major cardiovascular events (MACEs) were analyzed. Results:During a median follow-up of 31 months, 153 (21.7%) patients died, and 165 (23.4%) had MACEs. The prevalence of malnutrition was 29.8, 80.6, and 89.8% for the PNI, CONUT, and GNRI, respectively. All the malnutrition indexes were correlated with each other ( = 0.77 between GNRI and PNI,  = -0.72 between GNRI and CONUT, and  = -0.88 between PNI and CONUT, all  < 0.001). Compared with normal nutrition, malnutrition was independently associated with an increased risk for all-cause mortality (adjusted hazard ratio for moderate and severe degrees of malnutrition, respectively: 7.23 [95% confidence interval (CI): 2.69 to 19.49] and 17.56 [95% CI: 5.61 to 55.09] for the CONUT score, 2.18 [95% CI: 0.93 to 5.13] and 3.16 [95% CI: 1.28 to 7.79] for the GNRI, and 2.52 [95% CI: 1.62 to 3.94] and 3.46 [95% CI: 2.28 to 5.25] for the PNI score. values were lower than 0.05 for all nutritional indexes, except for moderate GNRI value = 0.075). As for MACEs, similar results were observed in the CONUT and PNI. All the risk scores could improve the predictive ability of the Global Registry of Acute Coronary Events (GRACE) risk score for both all-cause mortality and MACEs. Conclusion:Malnutrition was common in patients with ACS and CKD regardless of the screening tools used, and was independently associated with all-cause mortality and MACEs. Malnutrition scores could facilitate risk stratification and prognosis assessment.
  • 1区Q1影响因子: 22.3
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    9. Prevalence and Prognostic Significance of Malnutrition in Patients With Acute Coronary Syndrome.
    9. 急性冠脉综合征患者营养不良的患病率和预后意义。
    作者:Raposeiras Roubín Sergio , Abu Assi Emad , Cespón Fernandez María , Barreiro Pardal Cristina , Lizancos Castro Andrea , Parada Jose Antonio , Pérez David Dobarro , Blanco Prieto Sonia , Rossello Xavier , Ibanez Borja , Íñiguez Romo Andrés
    期刊:Journal of the American College of Cardiology
    日期:2020-08-18
    DOI :10.1016/j.jacc.2020.06.058
    BACKGROUND:Malnutrition is associated with poor prognosis in a wide range of illnesses. However, its prognostic impact in patients with acute coronary syndrome (ACS) is not well known. OBJECTIVES:This study sought to report the prevalence, clinical associations, and prognostic consequences of malnutrition in patients with ACS. METHODS:In this study, the Controlling Nutritional Status (CONUT) score, the Nutritional Risk Index (NRI), and the Prognostic Nutritional Index (PNI) was applied to 5,062 consecutive patients with ACS. The relationships between malnutrition risk and all-cause mortality and major cardiovascular events (MACEs) (cardiovascular mortality, reinfarction, or ischemic stroke) were examined. RESULTS:According to the CONUT score, NRI, and PNI, 11.2%, 39.5%, and 8.9% patients were moderately or severely malnourished, respectively; 71.8% were at least mildly malnourished by at least 1 score. Although worse scores were most strongly related to lower body mass index, between 8.4% and 36.7% of patients with a body mass index of ≥25 kg/m were moderately or severely malnourished, depending on the nutritional index used. During a median follow-up of 3.6 years (interquartile range: 1.3 to 5.3 years), 830 (16.4%) patients died, and 1,048 (20.7%) had MACEs. Compared with good nutritional status, malnutrition was associated with significantly increased risk for all-cause death (adjusted hazard ratio for moderate and severe degrees of malnutrition, respectively: 2.02 [95% confidence interval (CI): 1.65 to 2.49] and 3.65 [95% CI: 2.41 to 5.51] for the CONUT score, 1.40 [95% CI: 1.17 to 1.68] and 2.87 [95% CI: 2.17 to 3.79] for the NRI, and 1.71 [95% CI: 1.37 to 2.15] and 1.95 [95% CI: 1.55 to 2.45] for the PNI score; p values <0.001 for all nutritional indexes). Similar results were found for the CONUT score and PNI regarding MACEs. All risk scores improve the predictive ability of the GRACE (Global Registry of Acute Coronary Events) risk score for both all-cause mortality and MACEs. CONCLUSIONS:Malnutrition is common among patients with ACS and is strongly associated with increased mortality and cardiovascular events. Clinical trials are needed to prospectively evaluate the efficacy of nutritional interventions on outcomes in patients with ACS.
  • 3区Q1影响因子: 3.7
    10. Malnutrition in patients with coronary artery disease: Prevalence and mortality in a 46,485 Chinese cohort study.
    10. 冠心病患者营养不良:46485项中国队列研究中的患病率和死亡率。
    期刊:Nutrition, metabolism, and cardiovascular diseases : NMCD
    日期:2022-01-06
    DOI :10.1016/j.numecd.2021.12.023
    BACKGROUND AND AIMS:Malnutrition is associated with poor prognosis in a wide range of illnesses. However, its long-term prognostic impact in general coronary artery disease (CAD) patients is not well known. We aim to report the prevalence and long-term mortality of malnutrition in the whole general population. METHODS AND RESULTS:In this retrospective cohort study, the controlling nutritional status (CONUT) score was applied to 46,485 consecutive patients undergoing coronary angiography (CAG) and diagnosed with CAD from January 2007 to July 2018. Patients were stratified as having no malnutrition (n = 19,780), mild (n = 21,092), moderate (n = 5286) and severe malnutrition (n = 327), based on CONUT score. Overall, mean age was 63.1 ± 10.7 years, and 75.8% of patients (n = 35,250) were male. 45.4% of patients were mildly malnourished and 12.1% were moderately or severely malnourished. During a median follow-up of 5.1 years (interquartile range: 3.0-7.7 years), 6093 (17.3%) patients died. After adjusting for confounders, malnutrition risk was associated with significantly increased risk for all-cause death (mild vs. normal, HR = 1.19,95% confidence interval [CI]: 1.12 to 1.28; moderate vs. normal, HR = 1.42,95% CI: 1.30 to 1.55; severe vs. Normal, HR = 1.95, 95% CI: 1.57 to 2.41) (p for trend<0.001). The similar result on all-cause mortality was also found in different subgroups stratified by gender, chronic kidney disease, anemia, percutaneous coronary intervention. CONCLUSIONS:Malnutrition is a common complication among patients with CAD, and is strongly associated with increased mortality. Further studies need to explore the efficacy of nutritional interventions on long-term prognosis among CAD patients. This study was registered at Clinicaltrials.gov as NCT04407936.
  • 3区Q2影响因子: 3.4
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    11. Prognostic significance of controlling nutritional status in older adults with heart failure with preserved ejection fraction: a prospective comparative study with other objective nutritional indices.
    11. 预后的意义控制老年人营养状况与心力衰竭与射血分数保留:未来的比较研究与其他客观的营养指标。
    期刊:Aging clinical and experimental research
    日期:2023-04-01
    DOI :10.1007/s40520-023-02395-x
    OBJECTIVE:We explored the prognostic significance of controlling nutritional status (CONUT) score in older adults with heart failure with preserved ejection fraction (HFpEF) and compared CONUT with other objective nutritional indices. METHODS:This is a single-center retrospective cohort study in older adult coronary artery disease patients undergoing HFpEF. Clinical data and laboratory results were collected before discharge. CONUT, geriatric nutritional risk index (GNRI), and prognostic nutritional index (PNI) were calculated according to the formula. The primary endpoint of this study was readmission due to heart failure and all-cause mortality in the first year after hospitalization. RESULTS:A total of 371 older adults were enrolled. All patients were discharged and followed up for 1 year, and readmission for heart failure was 26% while all-cause mortality was 20%. Compared with the none and mild malnutrition risk group, the readmission rate for heart failure (HF) within 1 year (36% vs. 18%, 23%) and all-cause mortality rate in the moderate and severe malnutrition risk group (40% vs. 8%, 0%) were higher (P < 0.05). On multivariate logistic analysis, CONUT was not associated with readmission due to HF within 1 year. CONUT was significantly associated with all-cause mortality independently of GNRI or PNI, after adjustment for major confounders including age, bedridden; length of stay; history of chronic kidney disease; loop diuretics use; angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and beta-adrenergic blocking agents use; New York Heart Association (NYHA) functional class; hemoglobin; potassium; Creatinine; triglycerides; glycosylated hemoglobin; brain natriuretic peptide; left ventricular ejection fraction; GNRI and PNI via multivariable Cox analysis (HR (95% CI) 1.764 (1.503, 2.071); 1.646 (1.359, 1.992); 1.764 (1.503, 2.071), respectively). Kaplan-Meier analysis revealed that the risk of all-cause mortality significantly increased in accordance with a higher CONUT (CONUT 5-12 compare to 0-1:HR (95% CI) 6.16 (3.78, 10.06); CONUT 2-4 compare to 0-1:HR (95% CI) 0.16 (0.10, 0.26)). CONUT showed the best area under the curve value (0.789) for the prediction of all-cause mortality compared with the other objective nutritional indices. CONCLUSION:CONUT is a simple and strong prognostic indicator for the prediction of all-cause mortality in older adults with HFpEF. CLINICAL TRIALS: GOV IDENTIFIER:NCT05586828.
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