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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No: 2006-001108-35 |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to evaluate changes in left ventricular mass and cardiac function in patients with active acromegaly before and after treatment with the growth hormone receptor antagonist pegvisomant for one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegvisomant | Other | patients with active acromegaly and impaired cardiac function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegvisomant | Drug | booster dosage 80 mg once sc., than 10 mg once per day, uptitration in steps of 5 mg up to an IGF-1 level in the normal range (every 4 weeks), max. 30 mg once per day. Duration of treatment: one year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI). | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Ejection fraction,Enddiastolic thickness of the infero-lateral wall,Diastolic function,Left ventricular mass index,Stroke volume,Ejection fraction (MRI),CO,Late hyperenhancement,IGF-I,insulin sensitivity,Ringsize,adverse events,Endothelial function | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gwendolyn Bender, MD | Contact | 004993120139716 | bender_g@medizin.uni-wuerzburg.de | |
| Bruno Allolio, MD | Contact | 004993120139020 | allolio_b@medizin.uni-wuerzburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Allolio, MD | University of Wuerzburg. Department of Endocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wuerzburg, Department of Endocrinology | Recruiting | Würzburg | Bavaria | 97080 | Germany |
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|
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| D006333 | Heart Failure |
| D017379 | Hypertrophy, Left Ventricular |
| D006984 | Hypertrophy |
| D006332 | Cardiomegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C406545 | pegvisomant |
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