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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT00234520
Date of registration:	05/10/2005
Prospective Registration:	No
Primary sponsor:	Ipsen
Public title:	A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide
Scientific 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
Date of first enrolment:	May 2003
Target sample size:	225
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00234520
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Belgium	Czech Republic	Czechia	Denmark	France	Hungary	Italy	Poland
Spain	Sweden	United Kingdom

Contacts

Name:	Ipsen Medical Director
Address:
Telephone:
Email:
Affiliation:	Ipsen

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acromegaly

Intervention(s)

Primary Outcome(s)

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

Secondary Outcome(s)

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

Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months

Secondary ID(s)

2-47-52030-721

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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