Effects of Somatostatin on ADPKD Heart
Primary Purpose
Autosomal Dominant Polycystic Kidney Disease, Glomerular Filtration Rate > 40 ml/Min
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Octeotride
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OCTEOTRIDE
PLACEBO
Arm Description
Octeotride, 20 mg monthly intramuscular injection for 3 years
Placebo (salin soluction), intramuscular injection monthly for 3 years
Outcomes
Primary Outcome Measures
EFFECT ON LEFT VENTRICULAR DYASTOLIC FUNCTION
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02119013
Brief Title
Effects of Somatostatin on ADPKD Heart
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 Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney Disease, Glomerular Filtration Rate > 40 ml/Min
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCTEOTRIDE
Arm Type
Experimental
Arm Description
Octeotride, 20 mg monthly intramuscular injection for 3 years
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Placebo (salin soluction), intramuscular injection monthly for 3 years
Intervention Type
Drug
Intervention Name(s)
Octeotride
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
EFFECT ON LEFT VENTRICULAR DYASTOLIC FUNCTION
Description
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
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
eleonora riccio, md
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Effects of Somatostatin on ADPKD Heart
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