A multicenter prospective cohort study to develop frailty-based prognostic criteria in heart failure patients (FLAGSHIP): rationale and design

Abstract

BackgroundHeart failure (HF) and frailty often co-exist, and frailty in HF results in a poor prognosis. However, in Asian populations, prognostic criteria are needed to examine the effect of frailty on HF. Therefore, we conducted a nationwide cohort study to develop frailty-based prognostic criteria in HF patients (FLAGSHIP). FLAGSHIP mainly aims to 1) develop the frailty criteria based on HF-specific outcomes, 2) propose a hypothesis of the potential mechanisms of frailty manifestations in HF, and 3) examine the effects of outpatient cardiac rehabilitation on frailty.MethodsIn this prospective study, we consecutively enroll ambulatory patients admitted because of acute HF or exacerbation of HF and elderly patients admitted for acute myocardial infarction (age ≥ 70 years). They will be followed up for 2 years to assess frailty and hard clinical events. The primary endpoints of FLAGSHIP are cardiac events including cardiac mortality and HF-related readmission after discharge. Secondary endpoints are readmissions because of fracture or pneumonia and all-cause mortality. We used clinical data, including the items related to the frailty phenotype to develop diagnostic criteria for frailty and known prognostic factors of HF. Cognitive function, depression, and anorexia are also considered as potential components of frailty. As of March 2018, 2650 patients (85% was patients admitted for HF) have been registered from 30 collaborating hospitals nationwide in Japan.DiscussionFLAGSHIP provides diagnostic criteria and fundamental information on frailty manifestations to develop the best practices for the long-term management of HF. Diagnostic criteria on frailty developed by FLAGSHIP is expected to become a novel indicator for the stratification of patients at risk to functional decline after medical or surgical treatment, and in turn to contribute to the best practices in the long-term management of HF.Electronic supplementary materialThe online version of this article (10.1186/s12872-018-0897-y) contains supplementary material, which is available to authorized users.

Low educational level increases functional disability risk subsequent to heart failure in Japan: On behalf of the Iwate KENCO study group

“…Previous studies have shown some predictors of functional decline after HF [ 7 , 20 – 22 , 24 ]. While those studies examined risk factors for functional disability, their timing of assessment differed from our study, that is, while previous studies were conducted on hospital admission and/or at discharge, we gathered information on risk factors in subjects initially free of diseases and identified etiologic precursors by following up for 11 years.…”

“…The risk factors for HF have been well established in a previous cohort study [ 19 ]. Some studies have assessed functional disability using frailty [ 20 , 21 ], ADL [ 7 ], and muscle strength [ 22 ] after HF. Studies have identified risk factors for the development of disability in patients with HF [ 7 , 21 , 23 ].…”

Poor self-rated health predicts the incidence of functional disability in elderly community dwellers in Japan: a prospective cohort study

“…People with unfavorable social status Table 3 Hazard ratios for functional disability among the self-rated health groups excluding participants with sub-clinical and severe cases and unhealthy status might conceive their health as being poor, which consequently lead to be functional disability. CV diseases are well-known risks for future functional disability [38][39][40][41]. The main reasons for receiving LTCI were cerebrovascular disease (stroke) (21.5%) followed by dementia (15.3%) [42].…”

“…CV diseases are well-known risks for future functional disability [ 38 – 41 ]. The main reasons for receiving LTCI were cerebrovascular disease (stroke) (21.5%) followed by dementia (15.3%) [ 42 ].…”

Possibility of Cardio-renal Protection by Long-term Cardiac Rehabilitation in Elderly Patients with Cardiovascular Diseases

“…The low physical strength in elderly patients who are at risk of becoming frail must be addressed (15). The present study showed that the exercise capacity at AT was maintained by continuous CR for up to five years.…”