Effects of Somatostatin on ADPKD Heart

NCT ID: NCT02119013

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease; Glomerular Filtration Rate > 40 ml/Min

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OCTEOTRIDE

Octeotride, 20 mg monthly intramuscular injection for 3 years

Group Type: EXPERIMENTAL

Octeotride

Intervention Type: DRUG

PLACEBO

Placebo (salin soluction), intramuscular injection monthly for 3 years

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Octeotride

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Eleonora Riccio

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

eleonora riccio, md

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Other Identifiers

ADPKD-heart

Identifier Type: -

Identifier Source: org_study_id