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Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure: The FIT-HF Pilot Study
Frontiers in Cardiovascular Medicine ( IF 3.6 ) Pub Date : 2021-11-29 , DOI: 10.3389/fcvm.2021.785109
Michael C Wang 1 , Bridget Dolan 2 , Benjamin H Freed 3 , Lourdes Vega 2 , Nikola Markoski 2 , Amy E Wainright 2 , Bonnie Kane 1 , Laura E Seegmiller 1 , Katharine Harrington 1 , Alana A Lewis 3 , Sanjiv J Shah 1, 3 , Clyde W Yancy 3 , Ian J Neeland 4, 5 , Hongyan Ning 1 , Donald M Lloyd-Jones 1, 3 , Sadiya S Khan 1, 3
Affiliation  

Background: Given rising morbidity, mortality, and costs due to heart failure (HF), new approaches for prevention are needed. A quantitative risk-based strategy, in line with established guidelines for atherosclerotic cardiovascular disease prevention, may efficiently select patients most likely to benefit from intensification of preventive care, but a risk-based strategy has not yet been applied to HF prevention.

Methods and Results: The Feasibility of the Implementation of Tools for Heart Failure Risk Prediction (FIT-HF) pilot study will enroll 100 participants free of cardiovascular disease who receive primary care at a single integrated health system and have a 10-year predicted risk of HF of ≥5% based on the previously validated Pooled Cohort equations to Prevent Heart Failure. All participants will complete a health and lifestyle questionnaire and undergo cardiac biomarker (B-type natriuretic peptide [BNP] and high-sensitivity cardiac troponin I [hs-cTn]) and echocardiography screening at baseline and 1-year follow-up. Participants will be randomized 1:1 to either a pharmacist-led intervention or usual care for 1 year. Participants in the intervention arm will undergo consultation with a pharmacist operating under a collaborative practice agreement with a supervising cardiologist. The pharmacist will perform lifestyle counseling and recommend initiation or intensification of therapies to optimize risk factor (hypertension, diabetes, and cholesterol) management according to the most recent clinical practice guidelines. The primary outcome is change in BNP at 1-year, and secondary and exploratory outcomes include changes in hs-cTn, risk factor levels, and cardiac mechanics at follow-up. Feasibility will be examined by monitoring retention rates.

Conclusions: The FIT-HF pilot study will offer insight into the feasibility of a strategy of quantitative risk-based enrollment into a pharmacist-led prevention program to reduce heart failure risk.

Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT04684264



中文翻译:

药剂师主导的基于风险的心力衰竭预防干预的原理和设计:FIT-HF 试点研究

背景:鉴于心力衰竭 (HF) 导致的发病率、死亡率和成本不断上升,因此需要新的预防方法。根据既定的动脉粥样硬化性心血管疾病预防指南,基于风险的定量策略可以有效地选择最有可能从强化预防保健中受益的患者,但基于风险的策略尚未应用于心衰预防。

方法和结果:心力衰竭风险预测工具实施的可行性 (FIT-HF) 试点研究将招募 100 名无心血管疾病的参与者,他们在单一综合卫生系统接受初级保健,并且 10 年预测的 HF 风险≥5 % 基于先前验证的预防心力衰竭的汇集队列方程。所有参与者将完成一份健康和生活方式问卷,并在基线和 1 年随访时接受心脏生物标志物(B 型利钠肽 [BNP] 和高敏心肌肌钙蛋白 I [hs-cTn])和超声心动图筛查。参与者将以 1:1 的比例随机分配到药剂师主导的干预或常规护理 1 年。干预部门的参与者将与根据与监督心脏病专家的合作实践协议开展业务的药剂师进行咨询。药剂师将根据最新的临床实践指南进行生活方式咨询并建议开始或加强治疗以优化风险因素(高血压、糖尿病和胆固醇)管理。主要结果是 1 年 BNP 的变化,次要和探索性结果包括随访时 hs-cTn、危险因素水平和心脏力学的变化。可行性将通过监测保留率来检查。和胆固醇)根据最新的临床实践指南进行管理。主要结果是 1 年 BNP 的变化,次要和探索性结果包括随访时 hs-cTn、危险因素水平和心脏力学的变化。可行性将通过监测保留率来检查。和胆固醇)根据最新的临床实践指南进行管理。主要结果是 1 年 BNP 的变化,次要和探索性结果包括随访时 hs-cTn、危险因素水平和心脏力学的变化。可行性将通过监测保留率来检查。

结论:FIT-HF 试点研究将深入了解将基于风险的定量招募策略纳入药剂师主导的预防计划以降低心力衰竭风险的可行性。

临床试验注册:https://clinicaltrials.gov/ct2/show/NCT04684264

更新日期:2021-11-30
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