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Completed

NCT Number: NCT00234520

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

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

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques Universitaires Saint Luc, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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

  2. Risk in each of the 4 valves at 6 & 12 months

  3. Risk of significant regurgitation in each valve at 6 & 12 months

  4. Prevalence of valvular regurgitation at baseline

  5. Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 7, 2005
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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