Acromegaly
Conditions
Brief summary
The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide
Interventions
None listed
Sponsors
Ipsen
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium, Czechia, Denmark, France, Hungary, Italy, Poland, Spain, Sweden, United Kingdom
Outcome results
None listed