Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant
NCT ID: NCT00552851
Last Updated: 2010-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
4 participants
INTERVENTIONAL
2006-06-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pegvisomant
patients with active acromegaly and impaired cardiac function
pegvisomant
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
Interventions
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pegvisomant
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pegvisomant therapy is indicated (i. e. patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapy, or for whom these therapies are not appropriate)
* Evidence of left ventricular hypertrophy (infero-lateral wall thickness ≥ 12 mm assessed by echocardiography) or
* Evidence of impaired diastolic function (≥ stage 2 as assessed by echocardiography) or
* Evidence of systolic dysfunction (Ejection fraction \< 50% assessed by echocardiography)
* Stable medication for arterial hypertension and heart failure for 3 months
* Written informed consent.
Exclusion Criteria
* Previous therapy with Pegvisomant
* Suspected or known hypersensitivity to the drug or any of its components
* Contraindications for MRI
* History of malignancy during the last 5 years
* Suspected or known drug or alcohol abuse
* Patients who are neither able to self administer study medication on a daily basis nor have a caregiver who can administer study medication to the patient on a daily basis
* Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion
* Participation in another clinical trial
* Pituitary adenoma with a distance to the optic chiasm of \< 3 mm
* Any other drug for treatment of acromegaly (e.g. dopamine agonists, Somatostatin analogues) which would be necessary during the study or patients who apply for radiotherapy
* Instable heart insufficiency classified as NYHA IV.
* Severe renal insufficiency, liver transplantation
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
University of Wuerzburg
OTHER
Responsible Party
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Department of Endocrinology
Principal Investigators
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Bruno Allolio, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wuerzburg. Department of Endocrinology
Locations
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University of Wuerzburg, Department of Endocrinology
Würzburg, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EudraCT No: 2006-001108-35
Identifier Type: -
Identifier Source: secondary_id
NRA 6290010
Identifier Type: -
Identifier Source: org_study_id