Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant
NCT00552851
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Active acromegaly in adult subjects (≥ 18 years) after surgery and/or radiation therapy with elevated IGF-1 levels despite treatment with somatostatin analogues or dopamine agonists
- 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.
- Pregnancy and lactation period
- 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
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- Wuerzburg, Bavaria
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant | |||
| Official Title ICMJE | Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant: an Open-labelled, Prospective Study | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: 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 Name: Somavert | |||
| Study Arms ICMJE | Pegvisomant
patients with active acromegaly and impaired cardiac function Intervention: Drug: pegvisomant | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Unknown status | |||
| Estimated Enrollment ICMJE | 4 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Estimated Study Completion Date ICMJE | December 2010 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Germany | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00552851 | |||
| Other Study ID Numbers ICMJE | NRA 6290010 EudraCT No: 2006-001108-35 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Prof. Bruno Allolio, Department of Endocrinology | |||
| Study Sponsor ICMJE | University of Wuerzburg | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | University of Wuerzburg | |||
| Verification Date | September 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||