Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-04-08 @ 7:58 AM
Study NCT ID:
NCT00234520
Status:
COMPLETED
Last Update Posted:
2019-08-02
First Post:
2005-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000172', 'term': 'Acromegaly'}], 'ancestors': [{'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2005-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-01', 'studyFirstSubmitDate': '2005-10-05', 'studyFirstSubmitQcDate': '2005-10-05', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months'}], 'secondaryOutcomes': [{'measure': 'Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months'}, {'measure': 'Risk in each of the 4 valves at 6 & 12 months'}, {'measure': 'Risk of significant regurgitation in each valve at 6 & 12 months'}, {'measure': 'Prevalence of valvular regurgitation at baseline'}, {'measure': 'Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months'}]}, 'conditionsModule': {'conditions': ['Acromegaly']}, 'referencesModule': {'references': [{'pmid': '18381583', 'type': 'RESULT', 'citation': 'Colao A, Marek J, Goth MI, Caron P, Kuhn JM, Minuto FM, Weissman NJ. No greater incidence or worsening of cardiac valve regurgitation with somatostatin analog treatment of acromegaly. J Clin Endocrinol Metab. 2008 Jun;93(6):2243-8. doi: 10.1210/jc.2007-2199. Epub 2008 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a diagnosis of Acromegaly\n* 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\n* Patient started treatment with either lanreotide or octreotide when both products were available on the market in their country\n* Patient must not change treatment form lanreotide to octreotide or vice versa for the duration of the study\n\nExclusion Criteria:\n\n* Patients with known significant valve abnormalities prior to treatment with either lanreotide or octreotide\n* Patients who have received treatment with a somatostatin analogue other than lanreotide or octreotide for more than 3 months\n* Patients who have received treatment with a GH antagonist for more than 3 months\n* Patients who have had heart valve replacement therapy'}, 'identificationModule': {'nctId': 'NCT00234520', 'briefTitle': 'A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2-47-52030-721'}}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '44000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU de Liege', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '50005', 'city': 'Kralove', 'country': 'Czechia', 'facility': 'University Hospital, Charles University'}, {'zip': '12000', 'city': 'Prague', 'country': 'Czechia', 'facility': '1st School of Medicine, Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': 'DK-2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'National University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '76233', 'city': 'Bois-Guillaume', 'country': 'France', 'facility': 'Hôpital de Bois', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'zip': '43385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '54511', 'city': 'Nancy', 'country': 'France', 'facility': 'CHU de Brabois', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '45067', 'city': 'Orléans', 'country': 'France', 'facility': "Centre Hospitalier Régional d'Orléans", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Hôpital du Haut-Lévêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Hôpital Maison Blanche', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '31054', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '1088', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University Medical School', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1135', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'National Medical Center', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '24128', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Ospedali Riuniti di Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '20122', 'city': 'Ferrara', 'country': 'Italy', 'facility': 'Università degli Studi di Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '46100', 'city': 'Genova', 'country': 'Italy', 'facility': 'Dipartimento di Scienze, Endocrinologiche e Metaboliche', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Università degli Studi di Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'University "Federico II" of Naples', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Clinica Medica II', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '01809', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Bielanski Hospital', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '03012', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '28035', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Clínica Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Research Centre for Endocrinology and Metabolism', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '20502', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Endokrinologiska kliniken', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Sjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'B15 2TH', 'city': 'Edgbaston', 'state': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Medical Centre', 'geoPoint': {'lat': 52.4623, 'lon': -1.92115}}, {'zip': 'NW3 2QG', 'city': 'Hampstead', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.55744, 'lon': -0.18213}}, {'zip': 'HU3 2RW', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Michael White Diabetes Centre', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'S5 7AU', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Northern General Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}