EFFECT OF SOMATOSTTIN ON EARLY DIASTOLIC LEFT VENTRICULAR FUNCTION IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A MATCHED-COHORT, SPECKLE-TRACKING ECHOCARDIOGRAPHIC STUDY
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 主要终点
- EFFECT ON LEFT VENTRICULAR DYASTOLIC FUNCTION
研究概览
简要总结
Autosomal dominant polycystic kidney disease (ADPKD) is associated with early onset hypertension and left ventricular (LV) hypertrophy. Since LV hypertrophy is associated with LV diastolic function impairment, we aimed to assess the changes over time of LV diastolic function in ADPKD patients and whether they were affected by the treatment with the somatostatin analogue, octreotide.
35 ADPKD patients (14 males) aged 34±8 years (mean glomerular filtration rate 82±26 mL/min/1.73m2) were randomly assigned to 36 month treatment with placebo (n=18) or octreotide (n=17). Clinical and echocardiography parameters were evaluated at baseline and study end. LV mass (M) and ejection fraction (EF) were calculated according to Devereux formula and biplane Simpson's algorithm, respectively. LV filling was assessed by mitral and pulmonary vein flow velocity curves and mitral annulus early diastolic velocity peak (Ea) by tissue Doppler imaging.
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
- •diagnosis of autosomal dominant polycystic kidney disease
- •glomerular filtration rate grater than 40 ml/min
排除标准
- •diabetes mellitus
- •proteinuria greater than 1 g/24 hours
- •significant glomerular disease
- •urinary tract lithiasis and infections
- •symptomatic gallstones
- •biliary sludge
- •pregnant women
- •lactanting women
研究组 & 干预措施
OCTEOTRIDE
Octeotride, 20 mg monthly intramuscular injection for 3 years
干预措施: Octeotride (Drug)
PLACEBO
Placebo (salin soluction), intramuscular injection monthly for 3 years
干预措施: Placebo (Drug)
结局指标
主要结局
EFFECT ON LEFT VENTRICULAR DYASTOLIC FUNCTION
时间窗: 3 years
To assess the changes over time of left ventricular dyastolic function in ADPKD patients and whether they were affected by the treatment with the somatostatin analogue, octreotide
次要结局
未报告次要终点
研究者
Eleonora Riccio
MD
Federico II University
