The Effect of Angiotensin Receptor-Neprilysin Inhibition on Cardiac Fibrosis in Patients With HFpEF: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Extracellular volume [ECV]
研究概览
简要总结
The effectively therapeutic approaches for Heart failure with preserved ejection fraction (HFpEF) remain limited. The PARAGON-HF trial found that Angiotensin Receptor-Neprilysin Inhibition (ARNI) has potential benefits for the management of HFpEF. Nevertheless, the role of ARNI in cardiac fibrosis in HFpEF are still unclear. We will conduct a prospective randomized controlled trial to evaluate the effect of ARNI on cardiac fibrosis in patients with HFpEF by cardiac magnetic resonance (CMR).
详细描述
Heart failure with preserved ejection fraction (HFpEF) comprises approximately 50% of all heart failure. The effectively therapeutic approaches for HFpEF remain limited. The PARAGON-HF trial found that Angiotensin Receptor-Neprilysin Inhibition (ARNI) has potential benefits for the management of HFpEF. Nevertheless, the role of ARNI in cardiac fibrosis in HFpEF are still unclear. We will conduct a prospective randomized controlled trial to evaluate the effect of ARNI on cardiac fibrosis in patients with HFpEF by cardiac magnetic resonance (CMR). We will randomly assign 60 patients with HFpEF (NYHA II-IV) class, ejection fraction ≥ 50% and elevated level of natriuretic peptides to receive sacubitril-valsartan (target 100mg bid) or placebo (100mg bid). The primary endpoint is change in extracellular volume [ECV] measured by CMR. The secondary endpoints were 6-minute walking distance(6-WMD), KCCQ, hospitalizations for heart failure, myocardial infarction and death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent
- •Age ≥ 45 years at time of screening
- •Preserved systolic left ventricular function, defined by left ventricular ejection fraction (LVEF) ≥ 50%
- •NYHA classes II-IV
- •H2FPEF score ≥ 6 or HFA-PEFF score ≥ 5
排除标准
- •Patients with a known history of angioedema
- •History of hypersensitivity to ARNI
- •Any prior echocardiographic measurement of LVEF <45%
- •Significant congenital heart disease
- •Rheumatic valvular heart disease
- •Acute coronary syndrome, cardiac surgery, other major cardiovascular surgery
- •Probable alternative diagnoses could account for the patient's HF symptoms
- •Systolic blood pressure(BP) >180 mm Hg or diastolic BP >120 mm Hg at visit
- •Diastolic BP <90 mm Hg at visit 1, or symptomatic hypotension
- •Patients with a cardiac pacemaker therapy device
- •eGFR <30 ml/min/1.73 m2
- •Serum potassium >5.2 mmol/l at visit 1
- •Pregnant or nursing women
研究组 & 干预措施
HFpEF with ARNI treatment
Sacubitril/valsartan (ARNI, 100mg bid)
干预措施: Angiotensin Receptor-Neprilysin Inhibition (Drug)
Control group
placebo (100mg bid)
干预措施: Placebo (Drug)
结局指标
主要结局
Extracellular volume [ECV]
时间窗: Before ARNI or placebo treatment and after 3 months of continuous ANRI or palcebo treatment
Extracellular volume \[ECV\] assessment by CMR
次要结局
- myocardial infarction, hospitalization for heart failure and death(After 3 months of continuous ANRI or palcebo treatment)
研究者
Dongying Zhang
PhD
Chongqing Medical University