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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
Sponsor:
Information provided by (Responsible Party):
Eleonora Riccio, 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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: OCTEOTRIDE
Octeotride, 20 mg monthly intramuscular injection for 3 years
Drug: Octeotride
Placebo Comparator: PLACEBO
Placebo (salin soluction), intramuscular injection monthly for 3 years
Drug: Placebo



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119013


Sponsors and Collaborators
Federico II University
Investigators
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Principal Investigator: eleonora riccio, md Federico II University

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Responsible Party: Eleonora Riccio, MD, Federico II University
ClinicalTrials.gov Identifier: NCT02119013     History of Changes
Other Study ID Numbers: ADPKD-heart
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn