Transforming the Primary Prevention Paradigm for Heart Failure: Feasibility of the Implementation of Tools for Heart Failure Risk Prediction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Change from baseline in BNP at 1 year
研究概览
简要总结
The purpose of this study is to gather information to develop a heart failure screening and prevention program.
详细描述
All participants will undergo phlebotomy for specimen collection (BNP, hs-cTn, BMP and lipid testing, biorepository storage) and baseline echocardiography. All participants will additionally be administered a health and lifestyle questionnaire, undergo measurement of vital signs, and receive uniform education on heart-healthy lifestyle and signs and symptoms of heart failure. Participants who are randomized to the intervention arm will receive a referral to Heart Failure Prevention Clinic, a pharmacist-directed practice in collaboration with an attending cardiologist, where they will be followed for 1 year, with their primary care physician updated after each visit. The information from their BNP, hs-cTn, and echocardiography will be provided to them and their primary care physicians as well as the pharmacist and cardiologist team members. The participants (and their primary care providers) who are randomized to usual care will be blinded to their BNP and hs-cTn values and echocardiography results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10-year risk of heart failure >5% based on the PCP-HF equations
- •At least one primary care visit in the last 12 months
- •At least one additional primary care visit in the last 5 years
- •Had cholesterol and glucose checked within the past 5 years
排除标准
- •History of cardiovascular disease
- •Signs and symptoms of heart failure
- •Estimated glomerular filtration rate <45 mL/min/1.73m^2
- •Stage 3 or 4 cancer
- •Pregnancy
结局指标
主要结局
Change from baseline in BNP at 1 year
时间窗: baseline, 1-year
All participants will have brain natriuretic peptide (BNP) measured at baseline and at 1-year follow-up.
次要结局
- Change from baseline in hs-cTn at 1 year(baseline, 1-year)
- Change from baseline in BP at 1 year(baseline, 1-year)
- Change from baseline in serum glucose at 1 year(baseline, 1-year)
- Change from baseline in weight status at 1 year(baseline, 1-year)
- Change from baseline in creatinine at 1 year(baseline, 1-year)
- Change from baseline in LDL at 1 year(baseline, 1-year)
- Change from baseline in estimated glomerular filtration rate at 1 year(baseline, 1-year)
- Smoking quit attempt or cessation(baseline, 1-year)
研究者
Sadiya Khan
Assistant Professor of Medicine (Cardiology) and Preventive Medicine (Epidemiology)
Northwestern University