Acromegaly, Heart Failure, Hypertrophy, Left Ventricular
Conditions
Keywords
acromegaly, heart failure, hypertrophy, cardiomegaly
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.
Interventions
DRUGpegvisomant
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
Sponsors
Pfizer
University of Wuerzburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI). | one year |
Secondary
| Measure | 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 |
Countries
Germany
Contacts
Primary ContactGwendolyn Bender, MD
Backup ContactBruno Allolio, MD
Outcome results
None listed