drugset / Trial / NCT02119013

Effects of Somatostatin on ADPKD Heart

NCT02119013

Phase 2/3 Completed 35 enrolled Federico II University
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2009-01
Primary completion
2013-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Octreotide Peptide 20 mg Intramuscular