Clinical trial NCT00234520: A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide
Official title: A Multicentre Prospective Controlled Observer Blinded Cohort Study in Patients With Acromegaly to Evaluate the Risk of Cardiac Valvular Regurgitation in Patients Treated With Lanreotide Relative to Patients Treated With Octreotide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-10-07
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide


Eligibility criteria: Inclusion Criteria:

* Patient has a diagnosis of Acromegaly
* Patient is being treated with lanreotide or octreotide in any dose form at the selection visit or is a de novo patient who is due to commence treatment within 2 weeks of baseline
* Patient started treatment with either lanreotide or octreotide when both products were available on the market in their country
* Patient must not change treatment form lanreotide to octreotide or vice versa for the duration of the study

Exclusion Criteria:

* Patients with known significant valve abnormalities prior to treatment with either lanreotide or octreotide
* Patients who have received treatment with a somatostatin analogue other than lanreotide or octreotide for more than 3 months
* Patients who have received treatment with a GH antagonist for more than 3 months
* Patients who have had heart valve replacement therapy

Primary outcomes:
measure: Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months
Secondary outcomes:
measure: Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months
measure: Risk in each of the 4 valves at 6 & 12 months
measure: Risk of significant regurgitation in each valve at 6 & 12 months
measure: Prevalence of valvular regurgitation at baseline
measure: Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Liege
country: Belgium
facility: CHU de Liege
city: Kralove
country: Czechia
facility: University Hospital, Charles University
city: Prague 2
country: Czechia
facility: 1st School of Medicine, Charles University
city: Copenhagen
country: Denmark
facility: National University Hospital
city: Bois Guillaume
country: France
facility: Hôpital de Bois
city: Marseille
country: France
facility: Hôpital de la Timone
city: Nancy
country: France
facility: CHU de Brabois
city: Orleans
country: France
facility: Centre Hospitalier Régional d'Orléans
city: Pessac
country: France
facility: Hôpital du Haut-Lévêque
city: Reims
country: France
facility: Hôpital Maison Blanche
city: Toulouse
country: France
facility: CHU de Rangueil
city: Budapest
country: Hungary
facility: Semmelweis University Medical School
city: Budapest
country: Hungary
facility: National Medical Center
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
city: Ferrara
country: Italy
facility: Università degli Studi di Ferrara
city: Genova
country: Italy
facility: Dipartimento di Scienze, Endocrinologiche e Metaboliche
city: Milano
country: Italy
facility: Università degli Studi di Milano
city: Naples
country: Italy
facility: University "Federico II" of Naples
city: Roma
country: Italy
facility: Clinica Medica II
city: Warsaw
country: Poland
facility: Bielanski Hospital
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Madrid
country: Spain
facility: Clínica Puerta de Hierro
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Göteborg
country: Sweden
facility: Research Centre for Endocrinology and Metabolism
city: Malmö
country: Sweden
facility: Endokrinologiska kliniken
city: Stockholm
country: Sweden
facility: Karolinska Sjukhuset
city: Edgbaston
country: United Kingdom
facility: Queen Elizabeth Medical Centre
state: Birmingham
city: Hampstead
country: United Kingdom
facility: Royal Free Hospital
city: Hull
country: United Kingdom
facility: Michael White Diabetes Centre
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Colao A, Marek J, Goth MI, Caron P, Kuhn JM, Minuto FM, Weissman NJ. No greater incidence or worsening of cardiac valve regurgitation with somatostatin analog treatment of acromegaly. J Clin Endocrinol Metab. 2008 Jun;93(6):2243-8. doi: 10.1210/jc.2007-2199. Epub 2008 Apr 1.