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

Completed

• Conditions: Acromegaly

• Registration Number: NCT00234520
• Lead Sponsor: Ipsen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2005-02-18
• Study Completion: 2005-02-18
• Study First Submitted: 2005-10-05
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months

Secondary Outcome Measures

Name	Time	Method
Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months
Risk in each of the 4 valves at 6 & 12 months
Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months
Risk of significant regurgitation in each valve at 6 & 12 months
Prevalence of valvular regurgitation at baseline

Trial Locations

Locations (33)

Cliniques Universitaires Saint Luc; 🇧🇪 Bruxelles, Belgium

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

CHU de Liege; 🇧🇪 Liege, Belgium

University Hospital, Charles University; 🇨🇿 Kralove, Czechia

1st School of Medicine, Charles University; 🇨🇿 Prague 2, Czechia

National University Hospital; 🇩🇰 Copenhagen, Denmark

Hôpital de Bois; 🇫🇷 Bois Guillaume, France

Hôpital de la Timone; 🇫🇷 Marseille, France

CHU de Brabois; 🇫🇷 Nancy, France

Centre Hospitalier Régional d'Orléans; 🇫🇷 Orleans, France

Scroll for more (23 remaining)