NCT02119013

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

Completed Phase 2/Phase 3 Last updated 17 April 2014

What this trial tests

Phase 2/Phase 3 trial testing Octeotride in Autosomal Dominant Polycystic Kidney Disease in 35 participants. Completed.

Timeline

1 January 2009

Primary endpoint
1 September 2013

Quick facts

Lead sponsor	Federico II University
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	35
Start date	1 January 2009
Primary completion	1 September 2013

Drugs / interventions tested

• Octeotride — full drug profile →
• Placebo

Conditions studied

• Autosomal Dominant Polycystic Kidney Disease — all drugs for Autosomal Dominant Polycystic Kidney Disease →
• Glomerular Filtration Rate > 40 ml/Min — all drugs for Glomerular Filtration Rate > 40 ml/Min →

Sponsor

Federico II University

Who can join

Adults 18 to 80, any sex, with Autosomal Dominant Polycystic Kidney Disease or Glomerular Filtration Rate > 40 ml/Min. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• EFFECT ON LEFT VENTRICULAR DYASTOLIC FUNCTION
  Time frame: 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Experimental Models of Polycystic Kidney Disease: Applications and Therapeutic Testing.
   Sieben CJ, Harris PC. · · 2023 · cited 23× · PMID 37418622 · DOI 10.34067/kid.0000000000000209