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

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Brief 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

Official 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

Brief Summary

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

Study Type

Observational

Primary Outcome

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

Secondary Outcome

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

Condition

Acromegaly

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

225

Start Date

May 2003

Completion Date

February 18, 2005

Primary Completion Date

February 18, 2005

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations

NCT ID

NCT00234520

Organization ID

2-47-52030-721

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

August 2019