Effects of Somatostatin on ADPKD Heart

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

Official title:

EFFECT OF SOMATOSTTIN ON EARLY DIASTOLIC LEFT VENTRICULAR FUNCTION IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A MATCHED-COHORT, SPECKLE-TRACKING ECHOCARDIOGRAPHIC STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119013
• Other study ID #: ADPKD-heart
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 17, 2014
• Last updated: April 17, 2014
• Start date: January 2009

Study information

• Verified date: January 2014
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Glomerular Filtration Rate > 40 ml/Min
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Drug:
• Octeotride

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No