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

University of Wuerzburg1 site in 1 country4 target enrollmentJune 2006

ConditionsAcromegaly Heart Failure Hypertrophy, Left Ventricular

Interventionspegvisomant

Drugspegvisomant

Overview

Phase: Phase 4
Intervention: pegvisomant
Conditions: Acromegaly
Sponsor: University of Wuerzburg
Enrollment: 4
Locations: 1
Primary Endpoint: Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI).
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

December 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Wuerzburg

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

Arms & Interventions

Pegvisomant

patients with active acromegaly and impaired cardiac function

Intervention: pegvisomant

Outcomes

Primary Outcomes

Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI).

Time Frame: one year

Secondary Outcomes

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)