Slow-release CArvedilol in Patients With REduced Strain and Preserved Ejection Fraction Heart Failure (CARE-preserved HF): A Prospective Randomized, Double-Blinded, Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- GLS change
研究概览
简要总结
Beta-blockers improve clinical outcomes in heart failure and reduced ejection fraction (HFrEF); but not in those with preserved EF. Global longitudinal strain (GLS) is a prognostic factor independent of left ventricular ejection fraction (LVEF). In a retrospective with 1969 patients with HF and LVEF of ≥40%, beta-blocker was associated with improved survival in those with low GLS (GLS <14%), but not in those with GLS ≥14%. In this prospective, randomized clinical study, the investigators will assess the effect of slow-release carvedilol in patients with HFpEF and hypertension. The primary endpoint is the time-averaged proportional changes in NT-proBNP level and GLS change from baseline to month 6.
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, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥20 yrs
- •symptomatic HFpEF with LVEF≥50%
- •NT-proBNP ≥220 pg/ml (sinus rhythm) or ≥660 pg/ml(AF) (BNP ≥80 pg/ml (sinus rhythm) or ≥240 pg/ml(AF) )
- •SBP≥140mmHg and/or DBP ≥90mmHg, or if taking anti-hypertensive medication, SBP ≥110mmHg.
- •LAVI≥29(sinus rhythm)/34ml/m2 (AF) or LVMI≥115(male)/95(female) g/m2
- •meet one the following
- •Average E/e'≥ 9
- •Septal e' < 7 cm/s
- •Lateral e' <10 cm/s
- •TR velocity > 2.8 m/s
- •PASP > 35 mmHg
排除标准
- •systolic blood pressure < 110 mmHg, or heart rate < 60 beats/min
- •contra-indication to beta-blockers
- •creatinine> 2.4mg/dL
- •amyloidosis, hypertrophic cardiomyopathy with obstruction, severe aortic or mitral valve disease, acute coronary syndrome, Cerebrovascular event within 6 months, PCI within 3 months before
- •AST/ALT >3 x normal upper range
研究组 & 干预措施
Carvedilol-group
Patients receiving carvedilol
干预措施: Carvedilol (Drug)
Placebo-group
Patients receiving placebo
干预措施: Placebo (Drug)
结局指标
主要结局
GLS change
时间窗: 6 months
Change of GLS from baselin to 6 months
NT-proBNP change
时间窗: 6 months
Time averaged NT-proBNP change from baseline to 6 months
次要结局
- Mortality(6 months)
- rehospitalization(6 months)
- off-level NT-proBNP(6 months)
研究者
Dong-Ju Choi
Professor
Seoul National University Bundang Hospital