Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant

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