Viewing Study NCT02119013



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Last Modification Date: 2024-10-26 @ 11:23 AM
Study NCT ID: NCT02119013
Status: COMPLETED
Last Update Posted: 2014-04-21
First Post: 2014-04-17

Brief Title: Effects of Somatostatin on ADPKD Heart
Sponsor: Federico II University
Organization: Federico II University

Study Overview

Official Title: EFFECT OF SOMATOSTTIN ON EARLY DIASTOLIC LEFT VENTRICULAR FUNCTION IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE A MATCHED-COHORT SPECKLE-TRACKING ECHOCARDIOGRAPHIC STUDY
Status: COMPLETED
Status Verified Date: 2014-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 348 years mean glomerular filtration rate 8226 mLmin173m2 were randomly assigned to 36 month treatment with placebo n18 or octreotide n17 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 Simpsons 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: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None