Leveraging Exercise Stress Echocardiography for Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- HFpEF clinic visit at 1 month and 6 months
研究概览
简要总结
The purpose of this study is to find out if additional images taken during a stress echocardiogram study and risk score calculation will help the doctor determine if shortness of breath or chest pain are caused by stiff heart (heart failure with preserved ejection fraction or HFpEF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically indicated exercise stress echo for the evaluation of exertional dyspnea or chest pain
- •Age ≥50 years
排除标准
- •Known history of HFpEF
- •LVEF <50% on baseline echo study
- •History of hypertrophic cardiomyopathy, amyloidosis, or pulmonary arterial hypertension, severe right ventricular dysfunction and severe valvular disease based on chart review or baseline echo study
- •History of organ transplant (heart, kidney, liver, lungs)
- •Severe pulmonary disease requiring ambulatory oxygen therapy
- •End-stage renal disease requiring long-term renal replacement therapy
- •Decompensated liver disease
- •Conditions that prevent accurate assessment of E/e' ratio (mitral prosthetic valve, severe mitral annular calcification)
- •Plan to use echo contrast agent during stress study (i.e. contrast agent needed for baseline study)
- •Patients from outside Duke health system with no plan for long-term care at Duke
研究组 & 干预措施
Enrolled subjects undergoing clinical stress echocardiogram
The enrolled subject will undergo their clinically indicated stress echocardiogram study for chest pain or shortness of breath. At the conclusion of the clinical study 4 additional echo images will be obtained for research purposes.
干预措施: Echocardiogram (Diagnostic Test)
结局指标
主要结局
HFpEF clinic visit at 1 month and 6 months
时间窗: Within 6 months of participant enrollment
Number of participants undergoing resting only or exercise right heart catheterization
Confirmed HFpEF diagnosis at 1 month and 6 months
时间窗: Within 6 months of participant enrollment
Number of participants being documented to have HFpEF diagnosis in Electronic Health Record
Estimate the prevalence of undiagnosed HFpEF in patients undergoing exercise stress echo using HFpEF probability score and exercise echo filling pressure assessment
时间窗: Within 6 months of participant enrollment
Participants are presumed to have undiagnosed HFpEF using these following definitions: 1. Participants with H2FPEF score ≥6 2. Participants with elevated exercise echo filling pressure 3. Participants with H2FPEF score ≥6 or elevated exercise echo filling pressure The difference in undiagnosed HFpEF prevalence between definition #1 and #3 will inform the incremental diagnostic value of exercise echo filling pressure assessment.
次要结局
- HFpEF clinical referral at months 1 and 6(Within 6 months of participant enrollment)
- SGLT2 inhibitor use at baseline, months 1 and 6(Baseline at enrollment and 6 months post enrollment)
- Right heart catherization (both resting and exercise) referral at months 1 and 6(Within 6 months of participant enrollment)
- Right heart catheterization (both resting and exercise) visit at 1 month and 6 months(Within 6 months of participant enrollment)
- MRA Use at baseline, months 1 and 6(Baseline at enrollment and 6 months post enrollment)
- GLP1 RA use at baseline, months 1 and 6(Baseline at enrollment and 6 months post enrollment)