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Home » Clinical Trials » Acromegaly

Clinical Trial Details

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Acromegaly, Heart Failure or Hypertrophy, Left Ventricular

Research Study 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

Purpose

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.

To Learn more
Phase

4

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

University of Wuerzburg

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

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

Site Locations (1)

Country State City Zip Facility and Contact
Germany Bavaria Wuerzburg 97080 University of Wuerzburg, Department of Endocrinology
Gwendolyn Bender, MD
004993120139716
bender_g@medizin.uni-wuerzburg.de

Contact

Gwendolyn Bender, MD
004993120139716

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT00552851

Date Last Changed: September 23, 2010

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