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临床试验/NCT02119013
NCT02119013已完成2 期

EFFECT OF SOMATOSTTIN ON EARLY DIASTOLIC LEFT VENTRICULAR FUNCTION IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A MATCHED-COHORT, SPECKLE-TRACKING ECHOCARDIOGRAPHIC STUDY

Federico II University0 个研究点目标入组 35 人开始时间: 2009年1月最近更新:
适应症
干预措施

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

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

Experimental

Octeotride, 20 mg monthly intramuscular injection for 3 years

干预措施: Octeotride (Drug)

PLACEBO

Placebo Comparator

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

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eleonora Riccio

MD

Federico II University

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Effects of Somatostatin on ADPKD Heart | 临床试验