Aims Pulmonary congestion (PC) expressed by residual lung ultrasound B-lines (LUS-BL) could exist in some discharged heart failure (HF) patients, which is a known determinant of poor outcomes. Detection efficacy for PC is suboptimal with widely used imaging modalities, like X-ray or echocardiography, while lung ultrasound (LUS) can sufficiently detect PC by visualizing LUS-BL. In this trial, we sought to evaluate the impact LUS-BL-guided intensive HF management post-discharge on outcome of HF patients discharged with residual LUS-BL up to 1 year after discharge. IMP-OUTCOME is a prospective, single-centre, single-blinded, randomized cohort study, which is designed to investigate if LUS-BL-guided intensive HF management post-discharge in patients with residual LUS-BL could improve the clinical outcome up to 1 year after discharge or not. Methods and resultsAfter receiving the standardized treatment of HF according to current guidelines, 318 patients with ≥3 LUS-BL assessed by LUS within 48 h before discharge will be randomly divided into the conventional HF management group and the LUS-BL-guided intensive HF management group at 1:1 ratio. Patient-related basic clinical data including sex, age, blood chemistry, imaging examination, and drug utilization will be obtained and analysed. LUS-BL will be assessed at 2 month interval post-discharge in both groups, but LUS-BL results will be enveloped in the conventional HF management group, and diuretics will be adjusted based on symptom and physical examination results with or without knowing the LUS-BL results. Echocardiography examination will be performed for all patients at 12 month post-discharge. The primary endpoint is consisted of the composite of readmission for worsening HF and all-cause death during follow up as indicated. The secondary endpoints consisted of the change in the New York Heart Association classification, Duke Activity Status Index, N terminal pro brain natriuretic peptide value, malignant arrhythmia event and 6 min walk distance at each designed follow up, echocardiography-derived left ventricular ejection fraction, and number of LUS-BL at 12 month post-discharge. Safety profile will be recorded and managed accordingly for all patients. Conclusions This trial will explore the impact of LUS-BL-guided intensive HF management on the outcome of discharged HF patients with residual LUS-BL up to 1 year after discharge in the era of sodium-glucose cotransporter-2 inhibitors and angiotensin receptor blocker-neprilysin inhibitor. Trial Registration: ClinicalTrials.gov: NCT05035459
Background The disease burden from ischaemic heart disease remains heavy in the Chinese population. Traditional risk scores for estimating long-term mortality in patients with acute myocardial infarction (AMI) have been developed without sufficiently considering advances in interventional procedures and medication. The goal of this study was to develop a risk score comprising clinical parameters and intervention advances at hospital admission to assess 5-year mortality in AMI patients in a Chinese population. Methods We performed a retrospective observational study on 2,722 AMI patients between January 2013 and December 2017. Of these patients, 1,471 patients from Changsha city, Hunan Province, China were assigned to the development cohort, and 1,251 patients from Xiangtan city, Hunan Province, China, were assigned to the validation cohort. Forty-five candidate variables assessed at admission were screened using least absolute shrinkage and selection operator, stepwise backward regression, and Cox regression methods to construct the C2ABS2-GLPK score, which was graded and stratified using a nomogram and X-tile. The score was internally and externally validated. The C-statistic and Hosmer-Lemeshow test were used to assess discrimination and calibration, respectively. Results From the 45 candidate variables obtained at admission, 10 potential predictors, namely, including Creatinine, experience of Cardiac arrest, Age, N-terminal Pro-Brain Natriuretic Peptide, a history of Stroke, Statins therapy, fasting blood Glucose, Left ventricular end-diastolic diameter, Percutaneous coronary intervention and Killip classification were identified as having a close association with 5-year mortality in patients with AMI and collectively termed the C2ABS2-GLPK score. The score had good discrimination (C-statistic = 0.811, 95% confidence intervals (CI) [0.786–0.836]) and calibration (calibration slope = 0.988) in the development cohort. In the external validation cohort, the score performed well in both discrimination (C-statistic = 0.787, 95% CI [0.756–0.818]) and calibration (calibration slope = 0.976). The patients were stratified into low- (≤148), medium- (149 to 218) and high-risk (≥219) categories according to the C2ABS2-GLPK score. The predictive performance of the score was also validated in all subpopulations of both cohorts. Conclusion The C2ABS2-GLPK score is a Chinese population-based risk assessment tool to predict 5-year mortality in AMI patients based on 10 variables that are routinely assessed at admission. This score can assist physicians in stratifying high-risk patients and optimizing emergency medical interventions to improve long-term survival in patients with AMI.
Background:Discharged heart failure (HF) patients might still have lung congestion (PC) expressed by residual lung ultrasound B-lines (LU-BL). Detection efficacy for PC is suboptimal with widely used imaging modalities, like x-ray or echocardiography, while lung ultrasound (LU) can sufficiently detect PC by visualizing LU-BL. In this trial, we sought to evaluate the impact of residual LU-BL at discharge and other clinical indexes on rehospitalization due to HF and all-cause mortality (composite primary outcome) up to 1 year post discharge in HF patients. The impact of intensive HF therapy post discharge on outcome up to 1 year after discharge will also be investigated for discharged HF patients with evidence of PC.Aim: IMP-OUTCOME is a prospective, single-center, observational cohort study, which is designed to investigate whether residual LU-BL at discharge is one of the independent determinants of poor outcome in discharged HF patients and if intensive HF therapy (adding SGLT2 inhibitor and more frequent follow up including LU-BL assessment) post discharge could improve the outcome of discharged HF patients with residual LU-BL up to 1 year after discharge.Methods and results: After receiving the standardized treatment of HF according to current guidelines, 233 discharged HF patients will be grouped into < 3 LU-BL and ≥ 3 LU-BL groups according to LU measurement within 48 hours before discharge. Patients in the ≥ 3 LU-BL group will be further divided into the conventional HF therapy group and the intensive HF therapy group at 1:1 ratio. Intensive HF therapy group will be treated with an SGLT2 inhibitor, if not contraindicated, beyond other HF medications and monitored by HF nurses and cardiologists at 1-month interval by clinical visit. Patient-relates basic clinical data including sex, age, blood chemistry, imaging examination, drug utilization, and so on will be obtained and analyzed. Following discharge from the hospital, patients in the LU-BL<3 group and conventional HF therapy group will be followed up at 1 month, 3 months, 6 months, post discharge by clinical visit or telephone call, by clinical visit at 12 months post discharge. LU-BL will be assessed monthly post discharge in the intensive HF therapy group, and at 12 months post discharge for patients in the conventional HF therapy group and LU-BL<3 group. Echocardiography examination will be performed for all patients at 12 months post discharge. The primary endpoint is the composite of re-hospitalization for worsening HF and all-cause death during follow-up. Secondary endpoints include the change in the Duke Activity Status Index (DASI), NT-pro BNP value and 6-min walk distance at each follow up, EF and number of LU-BL at 12 months post discharge. Conclusion: This trial will explore the potential impact of residual B-lines on the outcome of discharged HF patients and the impact of intensive HF management on the outcome of discharged HF patients with residual LU-BL up to 1 year after discharge.Trial Registration ClinicalTrials.gov; NCT05035459. Registration date, 2021/09/02, “prospectively registered”.
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