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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acromegaly, Heart Failure, Hypertrophy, Left Ventricular

Intervention / Treatment
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* Drug: pegvisomant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pegvisomant<br>patients with active acromegaly and impaired cardiac function | Drug: pegvisomant<br>* 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<br>* Other names: Somavert;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI). |  | one year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acromegaly, heart failure, hypertrophy, cardiomegaly