Effects of Somatostatin on ADPKD Heart

Phase 2

Completed

• Conditions: Glomerular Filtration Rate > 40 ml/Min; Autosomal Dominant Polycystic Kidney Disease
• Interventions: Drug: Octeotride; Drug: Placebo

• Registration Number: NCT02119013
• Lead Sponsor: Federico II University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2013-09
• Status Verified: 2014-01
• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-04-17
• Last Update Submitted: 2014-04-17
• Study First Posted: 2014-04-21
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• diagnosis of autosomal dominant polycystic kidney disease
• glomerular filtration rate grater than 40 ml/min

Exclusion Criteria

• diabetes mellitus
• proteinuria greater than 1 g/24 hours
• significant glomerular disease
• urinary tract lithiasis and infections
• symptomatic gallstones
• biliary sludge
• cancer
• pregnant women
• lactanting women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCTEOTRIDE	Octeotride	Octeotride, 20 mg monthly intramuscular injection for 3 years
PLACEBO	Placebo	Placebo (salin soluction), intramuscular injection monthly for 3 years

Primary Outcome Measures

Name	Time	Method
EFFECT ON LEFT VENTRICULAR DYASTOLIC FUNCTION	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