IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Urinary albumin excretion
研究概览
简要总结
To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease.
详细描述
This is a multi-center, randomized, open-label, investigator-initiated study with a parallel design. Patients with type 2 diabetes and coronary heart disease who are microalbuminuric [urinary albumin excretion (UAE): 30-500 mg/day], will be randomized after informed consent, in a 1:1 ratio to the following treatment groups: Group Α: Ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day.
Group Β: Placebo. Urinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28).
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
- Single (Outcomes Assessor)
盲法说明
Urinary albumin excretion at 3 month
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes and coronary heart disease;
- •Urinary albumin excretion: 30-500mg/24h;
- •Sinus rhythm, and resting heart rate ≥ 70bpm;
排除标准
- •Renal dysfunction defined as eGFR < 30ml/min/1.73m^2;
- •Atrial flutter, and atrial fibrillation;
- •Resting heart rate < 70bpm;
- •Combined with non-dihydropyridine CCB;
- •UAE<30mg/24h, or > 500mg/24h;
- •Acute heart failure;
- •Low blood pressure (BP<90/50mmHg);
- •Acute myocardial infarction (<14 days);
研究组 & 干预措施
Ivabradine
Ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day.
干预措施: Ivabradine (Drug)
Sham Comparator
Urinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28).
干预措施: Sham Comparator (Other)
结局指标
主要结局
Urinary albumin excretion
时间窗: 3 month
Urinary albumin excretion at 3 month
次要结局
- Serum creatinine(3 month)
- Blood urea nitrogen(3 month)
- Cyscatin-c(3 month)
- Hypersensitive c-reactive protein (hsCRP)(3 month)
- β2-microglobulin(3 month)
- Neutrophil gelatinase-associated lipocalin(NGAL)(3 month)
- Albuminuria and urine creatinine ratio (ACR)(3 month)
- N-acyl-β-D-glucosidase(3 month)
- Retinol binding protein(3 month)
研究者
Shaoliang Chen
Vice President
Nanjing First Hospital, Nanjing Medical University