Brief Title
Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant
Official Title
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI).
Secondary Outcome
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
Condition
Acromegaly
Intervention
pegvisomant
Study Arms / Comparison Groups
Pegvisomant
Description: patients with active acromegaly and impaired cardiac function
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
4
Start Date
June 2006
Completion Date
December 2010
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bruno Allolio, MD, 004993120139716, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT00552851
Organization ID
NRA 6290010
Secondary IDs
EudraCT No: 2006-001108-35
Study Sponsor
University of Wuerzburg
Collaborators
Pfizer
Study Sponsor
Bruno Allolio, MD, Principal Investigator, University of Wuerzburg. Department of Endocrinology
Verification Date
September 2010