Evaluation of a Pragmatic NT-ProBNP-based Heart Failure Screening Strategy Among Patients with Type 2 Diabetes: STRONG-DM Study (Screening and Treatment Using Risk-based ApprOach with NT-ProBNP Guidance in Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Incident Heart Failure or All-cause death
研究概览
简要总结
A pragmatic, randomized clinical trial to evaluate the effect of a heart failure (HF) risk assessment and prevention strategy incorporating HF clinical risk scores (WATCH-DM) with cardiac biomarker (NT-proBNP) paired with a clinical decision support tool to implement an intensive prevention strategy among patients with high risk focused on implementation of evidence-based HF preventive therapies.
详细描述
Primary care providers will be randomized to receive notifications via the electronic health record if any patients with diabetes have high heart failure risk based on a combination of clinical risk scores(WATCH-DM), and biomarkers (NT-proBNP). Providers will be provided recommendation to initiate evidence based therapies (SGLT2 inhibitors, GLP1 agonists, non-steroidal MRA) , obtain expert e-consultation, or refer the patient to a cardiometabolic risk management program.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Care Provider that sees diabetes patients in clinic
排除标准
- •Provider does not see patients with Diabetes
结局指标
主要结局
Incident Heart Failure or All-cause death
时间窗: 2-year follow-up
Incident Heart Failure (based on electronic health record International Classification of Diseases codes) or all-cause death. This will be assessed via retrospective chart review.
次要结局
- Prescription Rates of SGLT2i(6-months from electronic health record alert.)
- Prescription Rate of Finerenone(6-months from electronic health record alert.)
- Prescription Rate of GLP1(6-months from electronic health record alert.)
研究者
Ambarish Pandey
Associate Professor of Internal Medicine
University of Texas Southwestern Medical Center