Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure: The FIT-HF Pilot Study.
Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure: The FIT-HF Pilot Study.
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DOI：
10.3389/fcvm.2021.785109
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发表时间：
2021
影响因子：
3.6
通讯作者：
Khan SS
中科院分区：
文献类型：
--
作者：
Wang MC;Dolan B;Freed BH;Vega L;Markoski N;Wainright AE;Kane B;Seegmiller LE;Harrington K;Lewis AA;Shah SJ;Yancy CW;Neeland IJ;Ning H;Lloyd-Jones DM;Khan SS
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，需要新的预防方法。一种基于定量风险的策略，与既定的动脉粥样硬化性心血管疾病预防指南相一致，或许能有效地筛选出最有可能从强化预防护理中获益的患者，但基于风险的策略尚未应用于心力衰竭的预防。
方法与结果：心力衰竭风险预测工具实施可行性（FIT - HF）试点研究将招募100名无心血管疾病的参与者，这些参与者在单一综合医疗系统接受初级医疗服务，且根据先前验证的预防心力衰竭合并队列方程，其10年心力衰竭预测风险≥5%。所有参与者将完成一份健康与生活方式调查问卷，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]和高敏肌钙蛋白I[hs - cTn]）检测及超声心动图筛查。参与者将按1:1的比例随机分为两组，分别接受为期1年的药剂师主导的干预或常规护理。干预组的参与者将在与监督心脏病专家签订合作医疗协议的药剂师处接受咨询。药剂师将进行生活方式指导，并根据最新的临床实践指南，建议启动或强化治疗，以优化对危险因素（高血压、糖尿病和胆固醇）的管理。主要结局指标是1年时BNP的变化，次要和探索性结局指标包括随访时hs - cTn、危险因素水平和心脏力学的变化。将通过监测留存率来检验可行性。
结论：FIT - HF试点研究将为基于定量风险招募策略纳入药剂师主导的预防项目以降低心力衰竭风险的可行性提供见解。
临床试验注册：https://clinicaltrials.gov/ct2/show/NCT04684264
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
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影响因子：
12.7
作者：
Glasgow, RE;Vogt, TM;Boles, SM
通讯作者：
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作者：
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Wijeysundera, Duminda N.
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作者：
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DOI：
10.1136/bmj.c3995
发表时间：
2010-08-23
期刊：
BMJ (Clinical research ed.)
影响因子：
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作者：
Clark CE;Smith LF;Taylor RS;Campbell JL
通讯作者：
Campbell JL
DOI：
10.1161/circheartfailure.120.007462
发表时间：
2020-11
期刊：
Circulation. Heart failure
影响因子：
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作者：
Bavishi A;Bruce M;Ning H;Freaney PM;Glynn P;Ahmad FS;Yancy CW;Shah SJ;Allen NB;Vupputuri SX;Rasmussen-Torvik LJ;Lloyd-Jones DM;Khan SS
通讯作者：
Khan SS