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
Prevalence of valvular regurgitation at baseline
Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months
Risk of significant regurgitation in each valve at 6 & 12 months

Trial Locations

Locations (33)

University "Federico II" of Naples; 🇮🇹 Naples, Italy

Cliniques Universitaires Saint Luc; 🇧🇪 Bruxelles, Belgium

CHU de Liege; 🇧🇪 Liege, Belgium

University Hospital, Charles University; 🇨🇿 Kralove, Czechia

Hôpital de Bois; 🇫🇷 Bois Guillaume, France

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

Hôpital de la Timone; 🇫🇷 Marseille, France

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

CHU de Brabois; 🇫🇷 Nancy, France

Hôpital du Haut-Lévêque; 🇫🇷 Pessac, France

Hôpital Maison Blanche; 🇫🇷 Reims, France

CHU de Rangueil; 🇫🇷 Toulouse, France

Clínica Puerta de Hierro; 🇪🇸 Madrid, Spain

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

Semmelweis University Medical School; 🇭🇺 Budapest, Hungary

Università degli Studi di Ferrara; 🇮🇹 Ferrara, Italy

National Medical Center; 🇭🇺 Budapest, Hungary

Dipartimento di Scienze, Endocrinologiche e Metaboliche; 🇮🇹 Genova, Italy

Clinica Medica II; 🇮🇹 Roma, Italy

Università degli Studi di Milano; 🇮🇹 Milano, Italy

Bielanski Hospital; 🇵🇱 Warsaw, Poland

Hospital General de Alicante; 🇪🇸 Alicante, Spain

Research Centre for Endocrinology and Metabolism; 🇸🇪 Göteborg, Sweden

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Royal Free Hospital; 🇬🇧 Hampstead, United Kingdom

Endokrinologiska kliniken; 🇸🇪 Malmö, Sweden

Northern General Hospital; 🇬🇧 Sheffield, United Kingdom

Christie Hospital; 🇬🇧 Manchester, United Kingdom

Queen Elizabeth Medical Centre; 🇬🇧 Edgbaston, Birmingham, United Kingdom

Karolinska Sjukhuset; 🇸🇪 Stockholm, Sweden

National University Hospital; 🇩🇰 Copenhagen, Denmark

Michael White Diabetes Centre; 🇬🇧 Hull, United Kingdom

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium