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NCT00234520 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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