Cilostazol for HFpEF (Heart Failure With a Preserved Ejection Fraction)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- KCCQ-12
研究概览
简要总结
Determine if cilostazol improves symptoms and NTproBNP levels (heart failure blood marker) in heart failure with preserved ejection fraction (HFpEF) - a prevalent syndrome without targeted evidence-based treatment.
This will be assessed in a prospective 1-month single blinded study with 2 cross-overs n-of-1 study design with placebo and cilostazol
详细描述
Heart failure (HF) is the #1 reason for hospital admissions. About half of the patients with HF have a preserved ejection fraction (HFpEF). There is no targeted evidence-based treatment for HFpEF. We recently reported that elevating the heart rate with pacemakers conveys clinical benefits e.g. reduction in heart failure symptoms, lowering filling pressures and an increase in walk distance. Cilostazol is a PDE3 inhibitor that increases the heart rate by about 5-8 beats per minute and has other potentially beneficial HFpEF effects such as peripheral vasodilation, lusitropic effects and dromotropic effects. By activating proteinkinase A, cilostazol may also phosphorylate titin, which may reduce myocardial stiffness.
n-of-1 study design using the standard dose cilostazol formulation of 100mg twice a day approved for peripheral vascular disease. The investigators and patients are blinded. The patients serve as their own controls with two crossovers (Week 1: cilostazol or placebo - Week 2: placebo or cilostazol - Week 3: cilostazol or placebo - Week 4: placebo or cilostazol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LVEF ≥ 50% (on last assessment, <2 years)
- •Diagnosis of HFpEF or Shortness of breath with NYHA Class ≥ 2 and one of the following:
- •pulmonary edema on chest imaging or documented on exam or on loop diuretics
- •NTproBNP >400 ng/ml in the last 24 months
- •HFpEF>50% hospitalization in the last 3 years
- •Qualitative echo: > mild diastolic dysfunction on echo report and > mild left ventricular hypertrophy and left atrial dilation or quantitative echo: left ventricular hypertrophy [men ≥115 g/m², women ≥95 g/m² or relative wall thickness >0.42 or any LV wall thickness >1.2cm and has LA dilation (>28ml/m2)
排除标准
- •resting heart rate >100/min
- •patients with LVEF <50%
- •advanced end-stage heart failure,
- •symptomatic COPD on home O2,
- •uncontrolled severe HTN (SBP >160/100 mmHg)
- •patients with life expectancy <6 months,
- •end-stage liver cirrhosis,
- •more than moderate valve disease,
- •infiltrative myocardial disease
- •constrictive pericarditis or myocarditis,
- •patients unable to participate in follow up,
- •pregnant patients or patients without reliable contraceptive agent for the duration of study participation),
- •left ventricular outflow tract obstruction,
- •bleeding dyscrasias, blood dyscrasias,
- •Patients on oral ketoconazole, itraconazole, fluconazole, miconazole, fluvoxamine, fluoxetine, nefazodone, sertraline, erythromycin, clarithromycin or azithromycin
研究组 & 干预措施
Placebo
First week, Placebo twice a day
Second week, Cilostazol 100mg twice a day
Third week, Placebo twice a day
Forth week, Cilostazol 100mg twice a day
干预措施: Placebo (Drug)
Cilostazol
First week, Cilostazol 100mg twice a day
Second week, Placebo twice a day
Third week, Cilostazol 100mg twice a day
Forth week, Placebo twice a day
干预措施: Cilostazol 100Mg Tab (Drug)
Cilostazol
First week, Cilostazol 100mg twice a day
Second week, Placebo twice a day
Third week, Cilostazol 100mg twice a day
Forth week, Placebo twice a day
干预措施: Placebo (Drug)
Placebo
First week, Placebo twice a day
Second week, Cilostazol 100mg twice a day
Third week, Placebo twice a day
Forth week, Cilostazol 100mg twice a day
干预措施: Cilostazol 100Mg Tab (Drug)
结局指标
主要结局
KCCQ-12
时间窗: 4 weeks
The Kansas City Cardiomyopathy Questionnaire contains 12 items that measure the effect of heart failure on health and quality of life. Total scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent
次要结局
- NTproBNP(1st and 3rd week)