Mitral Remodeling Index: A Novel Composite Measure the Effect of ARNI Alone Versus ARNI Combined With SGLT2 Inhibitors on Functional Mitral Regurgitation Remodeling.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- LVEF %
研究概览
简要总结
This study aimed to compare the effects of ARNI monotherapy versus combined ARNI and SGLT2 inhibitor therapy on Mitral Remodeling Index (MRIx) and Functional mitral regurgitation (FMR) remodeling in patients with heart failure with reduced ejection fraction (HFrEF).
详细描述
This was a study conducted at Madinah Cardiac Center (MCC), Saudi Arabia, a tertiary referral center with a high-volume heart-failure unit and advanced echocardiographic services. Consecutive patients with chronic heart failure with reduced ejection fraction (HFrEF) and functional mitral regurgitation (FMR) were enrolled between [January 2025] and [December 2025].
Eligible patients were on sacubitril/valsartan (ARNI), either as monotherapy or in combination with a sodium-glucose cotransporter-2 (SGLT2) inhibitor, according to contemporary heart failure guidelines and treating physician discretion.
The study protocol conformed to the principles of the Declaration of Helsinki and was approved by the local institutional ethics committee; Madinah Cardiac Center before the beginning of the study.
• Treatment Groups
Patients were stratified into two groups based on pharmacological therapy:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years;
- •left ventricular ejection fraction (LVEF) <50%;
- •Presence of functional mitral regurgitation (mild, moderate, or severe) on transthoracic echocardiography; and
- •stable sinus rhythm or controlled atrial fibrillation.
排除标准
- •primary (degenerative or rheumatic) mitral valve disease,
- •prior mitral valve surgery or transcatheter intervention,
- •acute decompensated heart failure within four weeks,
- •significant primary valvular disease other than FMR,
- •severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m²),
- •inadequate echocardiographic image quality.
研究组 & 干预措施
ARNI Monotherapy Group:
Patients receiving sacubitril/valsartan without concomitant SGLT2 inhibitor therapy.
干预措施: Sacubitril/Valsartan 49 MG-51 MG Oral Tablet [ENTRESTO] (Drug)
Combination Therapy Group:
Patients receiving sacubitril/valsartan in combination with an SGLT2 inhibitor (empagliflozin 10 mg daily).
干预措施: Empagliflozin10Mg Tab (Drug)
结局指标
主要结局
LVEF %
时间窗: 6 months
Change in left ventricular ejection fraction percent
Left Atrial Volume index (LAVI)
时间窗: 6 months
Change Left Atrial Volume index (LAVI)
Mitral Remodeling Index
时间窗: 6 months
Change in Mitral Remodeling Index
Peak GLS number
时间窗: 6 months
Change in Peak Global Longitudinal Strain
次要结局
未报告次要终点
研究者
Rehab Werida
Associate Professor
Damanhour University