Autosomal Dominant Polycystic Kidney Disease, Glomerular Filtration Rate > 40 ml/Min
Conditions
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.
Interventions
DRUGOcteotride
DRUGPlacebo
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EFFECT ON LEFT VENTRICULAR DYASTOLIC FUNCTION | 3 years | 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 |
Outcome results
None listed