Effects of Somatostatin on ADPKD Heart

NCT02119013 | Completed Phase 2

• 1 other identifier: ADPKD-heart
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Study Arms (2)

OCTEOTRIDE

EXPERIMENTAL

Octeotride, 20 mg monthly intramuscular injection for 3 years

Drug: Octeotride

PLACEBO

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Octeotride DRUG

OCTEOTRIDE

Placebo DRUG

PLACEBO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of autosomal dominant polycystic kidney disease
• glomerular filtration rate grater than 40 ml/min

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• eleonora riccio, md

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 21, 2014
• Study Start: January 1, 2009
• Primary Completion: September 1, 2013
• Last Updated: April 21, 2014

Record last verified: 2014-01