A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide

Acromegaly Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234520
• Other study ID #: 2-47-52030-721
• Status: Completed
• Start date: May 2003
• Est. completion date: February 18, 2005

Study information

• Verified date: August 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: February 18, 2005
• Est. primary completion date: February 18, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Bruxelles
Belgium	UZ Gasthuisberg	Leuven
Belgium	CHU de Liege	Liege
Czechia	University Hospital, Charles University	Kralove
Czechia	1st School of Medicine, Charles University	Prague 2
Denmark	National University Hospital	Copenhagen
France	Hôpital de Bois	Bois Guillaume
France	Hôpital de la Timone	Marseille
France	CHU de Brabois	Nancy
France	Centre Hospitalier Régional d'Orléans	Orleans
France	Hôpital du Haut-Lévêque	Pessac
France	Hôpital Maison Blanche	Reims
France	CHU de Rangueil	Toulouse
Hungary	National Medical Center	Budapest
Hungary	Semmelweis University Medical School	Budapest
Italy	Ospedali Riuniti di Bergamo	Bergamo
Italy	Università degli Studi di Ferrara	Ferrara
Italy	Dipartimento di Scienze, Endocrinologiche e Metaboliche	Genova
Italy	Università degli Studi di Milano	Milano
Italy	University "Federico II" of Naples	Naples
Italy	Clinica Medica II	Roma
Poland	Bielanski Hospital	Warsaw
Spain	Hospital General de Alicante	Alicante
Spain	Clínica Puerta de Hierro	Madrid
Spain	Fundación Jiménez Díaz	Madrid
Sweden	Research Centre for Endocrinology and Metabolism	Göteborg
Sweden	Endokrinologiska kliniken	Malmö
Sweden	Karolinska Sjukhuset	Stockholm
United Kingdom	Queen Elizabeth Medical Centre	Edgbaston	Birmingham
United Kingdom	Royal Free Hospital	Hampstead
United Kingdom	Michael White Diabetes Centre	Hull
United Kingdom	Christie Hospital	Manchester
United Kingdom	Northern General Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Belgium,  Czechia,  Denmark,  France,  Hungary,  Italy,  Poland,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

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.2007-21 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months
Secondary	Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months
Secondary	Risk in each of the 4 valves at 6 & 12 months
Secondary	Risk of significant regurgitation in each valve at 6 & 12 months
Secondary	Prevalence of valvular regurgitation at baseline
Secondary	Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months