Discriminative and Prognostic Value of Myocardial Energetics and Pressure-Volume Loop Parameters Derived From Cardiac MRI in Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 5,500
- 主要终点
- Number of Participants with All-Cause Death
研究概览
简要总结
This is a multi-center, observational study designed to evaluate the discriminative and prognostic value of pressure-volume (PV) loop analysis parameters and myocardial energetics derived from cardiac MRI in patients with heart failure with preserved ejection fraction (HFpEF). This study plans to enroll 3000 adult HFpEF patients and 500 adult healthy controls. The primary clinical endpoint was a composite of all-cause mortality and heart failure hospitalization, with events ascertained through medical records, clinic visits, and telephone follow-up. This study aims to determine whether cardiac MRI-derived PV loop analysis parameters and myocardial energetics provide incremental discriminative and prognostic information beyond conventional cardiac MRI parameters in patients with HFpEF. The study is non-interventional and does not involve any investigational drugs or devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptoms and/or signs of HF ≥ New York Heart Association (NYHA) class II;
- •Left ventricular ejection fraction (LVEF) of 50% or higher;
- •N-terminal fragment of the prohormone of brain natriuretic peptide (NT-proBNP) level > 125 pg/mL or brain natriuretic peptide (BNP) level > 35 pg/mL in sinus rhythm, or NT-proBNP level > 365 pg/mL or BNP level > 105 pg/mL in atrial fibrillation;
- •At least one of objective indicators of (i) cardiac structural abnormalities including LA maximum volume index (LAVi max) > 29 mL/m2 or echocardiography-measured LV end-diastolic mass index (LVMi) ≥ 115 g/m2 for men and ≥ 95 g/m2 for women, and (ii) LV diastolic dysfunction including early and/or late diastolic mitral inflow velocity (E/A) < 1 or early diastolic mitral inflow velocity and/or mitral annular peak early diastolic velocity (E/e') > 13.
排除标准
- •Primary cardiomyopathy;
- •Acute coronary syndrome;
- •Primary severe valvular heart disease;
- •Acute pulmonary embolism;
- •Severe renal dysfunction;
- •Poor image quality that was insufficient to identify myocardial endocardium and epicardium.
研究组 & 干预措施
HFpEF patients
Heart failure with preserved ejection fraction (HFpEF) patients
Healthy controls
Sex- and age-matched healthy controls
结局指标
主要结局
Number of Participants with All-Cause Death
时间窗: 3-year
All-cause death was defined as death from any cause occurring during the 3-year follow-up period. Mortality status was ascertained through review of medical records, hospital discharge summaries, and follow-up contacts.
次要结局
- Number of Participants with Cardiovascular Death(3-year)
- Number of Participants with Heart Failure Hospitalization(3-year)
研究者
Minjie Lu
MD, PhD
Chinese Academy of Medical Sciences, Fuwai Hospital