Effects of Somatostatin on ADPKD Heart
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|ClinicalTrials.gov Identifier: NCT02119013|
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : April 21, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Autosomal Dominant Polycystic Kidney Disease Glomerular Filtration Rate > 40 ml/Min||Drug: Octeotride Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||EFFECT OF SOMATOSTTIN ON EARLY DIASTOLIC LEFT VENTRICULAR FUNCTION IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A MATCHED-COHORT, SPECKLE-TRACKING ECHOCARDIOGRAPHIC STUDY|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||September 2013|
Octeotride, 20 mg monthly intramuscular injection for 3 years
Placebo Comparator: PLACEBO
Placebo (salin soluction), intramuscular injection monthly for 3 years
- EFFECT ON LEFT VENTRICULAR DYASTOLIC FUNCTION [ Time Frame: 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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119013
|Principal Investigator:||eleonora riccio, md||Federico II University|