Effects of Somatostatin on ADPKD Heart

Federico II University

Status and phase: Completed; Phase 3; Phase 2

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

Treatments: Drug: Placebo; Drug: Octeotride

Study type: Interventional

Funder types: Other

Identifiers

NCT02119013

ADPKD-heart

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

OCTEOTRIDE

Experimental group

Description:

Octeotride, 20 mg monthly intramuscular injection for 3 years

Treatment:

Drug: Octeotride

PLACEBO

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo