ISRCTN74144960招募中2 期
Metformin versus placebo in patients with heart failure with preserved ejection fraction and obesity or insulin resistance (MET-HFpEF)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
研究概览
简要总结
暂无简介。
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 98 Years（—）
- 性别
- All
入选标准
- •Willing/able to consent
- •Aged =18 years
- •Symptomatic HFpEF (NYHA II–III)
- •Elevated indexed left ventricular (LV) mass on screening echo (males >81 g/h¹·7, females >60 g/h¹·7)
- •Insulin resistance (Fasting Insulin Resistance Index [FIRI] =2.7) or pre-diabetes (HbA1c 39–47 mmol/mol) or body mass index (BMI) =30 kg/m²
- •NT-proBNP >300 pg/mL (sinus rhythm) or >600 pg/mL (AF)
- •Left ventricular ejection fraction (LVEF) =45%
- •On loop diuretics
- •Able/willing to comply
排除标准
- •Type 1 or 2 diabetes
- •HbA1c >47 mmol/mol
- •SBP >180 mmHg
- •eGFR <30 ml/min/1.73 m²
- •Contraindications to CMR
- •Previous LVEF <40%
- •Metformin hypersensitivity
- •Severe cognitive impairment
- •Active malignancy or other life-threatening disease
- •Hepatic insufficiency or history of alcoholism
- •Acute conditions affecting renal function
- •Pregnancy/lactation
- •Participation in another trial within 30 days
- •Investigator discretion
研究者
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