Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months
A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide
Status
Completed
Phase
Not applicable
Enrollment
225
Locations
33
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide
Interventions
Treatment arms and agents.
No intervention details reported.
Timeline
From registration to results.
First posted
Oct 7, 2005
Study start
May 2003
Primary completion
Feb 18, 2005
Study completion
Feb 18, 2005
Results posted
Not reported
Registry updated
Aug 2, 2019
Outcomes
What the study measures.
Primary outcomes
Secondary outcomes
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
Risk of significant regurgitation in each valve at 6 & 12 months
Prevalence of valvular regurgitation at baseline
Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
33 registered sites.
Belgium · Czechia · Denmark · France · Hungary · Italy · Poland · Spain · Sweden · United Kingdom. Showing up to 24 locations stored in the fast local snapshot.
Cliniques Universitaires Saint Luc
Brussels, Belgium
UZ Gasthuisberg
Leuven, Belgium
CHU de Liege
Liège, Belgium
University Hospital, Charles University
Kralove, Czechia
1st School of Medicine, Charles University
Prague, 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
Orléans, France
Hôpital du Haut-Lévêque
Pessac, France
Hôpital Maison Blanche
Reims, France
CHU de Rangueil
Toulouse, France
Semmelweis University Medical School
Budapest, Hungary
National Medical Center
Budapest, Hungary
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
Milan, Italy
University "Federico II" of Naples
Naples, Italy
Clinica Medica II
Roma, Italy
Bielanski Hospital
Warsaw, Poland
Hospital General de Alicante
Alicante, Spain
Clínica Puerta de Hierro
Madrid, Spain
Publications
Results and literature.
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Put the record in context.
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