Nascimento Daniela Meirelles do, Wolffenbüttel Pâmela Iná, Goldraich Lívia Adams, Schaan Beatriz, Clausell Nadine
Laboratory of Physical Activity, Diabetes and Cardiovascular Disease, Clinical Research Center, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil
Laboratory of Physical Activity, Diabetes and Cardiovascular Disease, Clinical Research Center, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.
BMJ Open. 2025 Aug 14;15(8):e101819. doi: 10.1136/bmjopen-2025-101819.
Heart failure (HF) is a debilitating condition associated with high morbidity, mortality and healthcare resource use. Frailty in HF patients is associated with poorer outcomes, including increased morbidity, mortality and reduced quality of life (QoL). Nutritional disorders, such as malnutrition, are common in patients with HF and contribute to functional decline and increased mortality. The Meta-Analysis Global Group in Chronic HF (MAGGIC) risk score was developed to predict 1-year and 3-year hospitalization and mortality in patients with HF. This study aims to assess the added value of frailty, QoL and nutritional status to the MAGGIC risk score.
This prospective cohort study, conducted at a tertiary public hospital in southern Brazil, will include 316 patients with chronic HF who are followed up at the HF Outpatient Clinic. Frailty will be assessed using the Fried scale, health-related QoL will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and nutritional status will be assessed using the Mini Nutritional Assessment. These variables will be incorporated into the MAGGIC risk score. Continuous variables with a normal distribution will be described as mean±SD, skewed variables as median±IQR and categorical variables as absolute and relative frequencies. Survival analysis will be performed using the Kaplan-Meier method with log-rank test comparisons. The prognostic value of frailty, its components, the MLHFQ score and nutritional status will be assessed by Cox regression, which will be adjusted for the MAGGIC risk score. Net Reclassification Improvement and Integrated Discrimination Improvement will assess the accuracy of the MAGGIC score when including frailty, MLHFQ and nutritional status. A p value <0.05 will be considered statistically significant.
This study adheres to the Declaration of Helsinki and was approved by the Institutional Committee for Scientific Ethics and Research (No 20220558) and the Brazilian Government Registry (No 66474223200005327). The data will be available on reasonable request from the corresponding author. The results will be disseminated via peer-reviewed manuscripts and shown at national and international conferences.
心力衰竭（HF）是一种使人衰弱的疾病，与高发病率、死亡率及医疗资源使用相关。HF患者的衰弱与更差的预后相关，包括发病率增加、死亡率上升及生活质量（QoL）下降。营养紊乱，如营养不良，在HF患者中很常见，并导致功能衰退和死亡率增加。慢性HF荟萃分析全球组（MAGGIC）风险评分用于预测HF患者1年和3年的住院率及死亡率。本研究旨在评估衰弱、QoL和营养状况对MAGGIC风险评分的附加价值。
这项前瞻性队列研究在巴西南部的一家三级公立医院进行，将纳入316例在HF门诊接受随访的慢性HF患者。使用Fried量表评估衰弱，使用明尼苏达心力衰竭生活问卷（MLHFQ）评估与健康相关的QoL，使用微型营养评定法评估营养状况。这些变量将纳入MAGGIC风险评分。呈正态分布的连续变量将描述为均值±标准差，偏态变量描述为中位数±四分位数间距，分类变量描述为绝对和相对频率。采用Kaplan-Meier法进行生存分析，并进行对数秩检验比较。将通过Cox回归评估衰弱、其组成部分、MLHFQ评分和营养状况的预后价值，并针对MAGGIC风险评分进行调整。净重新分类改善和综合鉴别改善将评估纳入衰弱、MLHFQ和营养状况时MAGGIC评分的准确性。p值<0.05将被视为具有统计学意义。
本研究遵循《赫尔辛基宣言》，并获得机构科学伦理与研究委员会（编号20220558）和巴西政府注册机构（编号66474223200005327）的批准。如有合理请求，可向通讯作者获取数据。研究结果将通过同行评审的手稿进行传播，并在国内和国际会议上展示。
