Clinical trial NCT00552851: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acromegaly
Heart Failure
Hypertrophy, Left Ventricular
Keywords: acromegaly
heart failure
hypertrophy
cardiomegaly
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-11-02
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI).
timeFrame: one year
Secondary outcomes:
measure: 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
timeFrame: one year
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University of Wuerzburg, Department of Endocrinology
state: Bavaria
Study officials:
affiliation: University of Wuerzburg. Department of Endocrinology
name: Bruno Allolio, MD
role: PRINCIPAL_INVESTIGATOR
References: