Effects of Somatostatin on ADPKD Heart

Related Clinical Trial
IMPEDE-PKD Randomised Placebo-controlled Trial Daily Caloric Restriction in ADPKD To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy Volunteers and Autosomal Dominant Polycystic Kidney Disease Subjects Establishment of the Human Intestinal and Salivary Microbiota Biobank – Kidney Diseases NOX4 and Related Biomarkers in ADPKD A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD) An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN) PKD Biomarkers Study Sirolimus for Massive Polycystic Liver Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt The German ADPKD Tolvaptan Treatment Registry A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD) Statin Therapy in Patients With Early Stage ADPKD Evaluation of Iliac and Renal Artery for Mechanism of Intracranial Aneurysm in ADPKD A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases – PHOENIX PKD Clinical and Translational Core Study Dynamic Measurement of Renal Functional Reserve as a Predictor of Long-Term Renal Function Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease Renal Sympathetic Denervation for Reduction of Pain and Improvement of Insulin Sensitivity in Adult Polycystic Kidney Disease Evaluation of Nephrectomy Specimen for Intracranial Aneurysm Development in ADPKD Lanreotide In Polycystic Kidney Disease Study Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease Dietary Intervention in ADPKD on Tolvaptan High Water Intake in Polycystic Kidney Disease Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease A Trial of Bardoxolone Methyl in Patients With ADPKD – FALCON Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD Tolvaptan-Octreotide LAR Combination in ADPKD Polycystic Kidney Disease Data Repository ADPKD Patient Registry Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease ADPKD Cohort Study Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD Canadian Medical Assessment of JINARC™ Outcomes Registry Analysis of Clinical and Molecular Genetic Data Influencing the Evolution and Response to Therapy of ADPKD Patients (Autosomal Dominant Polycystic Kidney Disease) ADPKD Alterations in Hepatic Transporter Function Efficacy Study of Water Drinking on PKD Progression. A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up Study Open-Label Tolvaptan Study in Subjects With ADPKD Effects of Somatostatin on ADPKD Heart Clinical and Molecular Description of PKD1 and PKD2 Mutation Negative Carriers in ADPKD Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney Disease Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to Therapy Effect of the Aquaretic Tolvaptan on Nitric Oxide System Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) Outcome of Autosomal Dominant Polycystic Kidney Disease Patients on Peritoneal Dialysis: a National Retrospective Study Based on Two French Registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network). Clinical Implications of DNA Analysis on ADPKD The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease Assessment of Longitudinal Changes in Endothelial Function and Oxidative Stress in Normotensive Patients With ADPKD The Eurocyst Initiative: Building a Network of ADPKD Reference Centers Across Europe Efficacy of Tolvaptan on ADPKD Patients Pravastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001] A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002] Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency ADPKD and Peritoneal Dialysis: How Anticipate Peritoneal Pressure? Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan] Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease The ELiSA Study – Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease) New Quantitive MRI Parameters in Assessing Kidneys of Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease Somatic Mutation Biorepository Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD) A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease Repository Study of Autosomal Dominant Polycystic Kidney Disease Sirolimus In Autosomal Dominant Polycystic Kidney Disease And Severe Renal Insufficiency Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix™ Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patients With Severe Debilitating Pain Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD) 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Brief Title

Effects of Somatostatin on ADPKD Heart

Official Title

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

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.
    


Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

EFFECT ON LEFT VENTRICULAR DYASTOLIC FUNCTION


Condition

Autosomal Dominant Polycystic Kidney Disease

Intervention

Octeotride

Study Arms / Comparison Groups

 OCTEOTRIDE
Description:  Octeotride, 20 mg monthly intramuscular injection for 3 years

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

35

Start Date

January 2009


Primary Completion Date

September 2013

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

eleonora riccio, md, , 



Administrative Informations


NCT ID

NCT02119013

Organization ID

ADPKD-heart


Responsible Party

Principal Investigator

Study Sponsor

Federico II University


Study Sponsor

eleonora riccio, md, Principal Investigator, Federico II University


Verification Date

January 2014