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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00552851
• Other study ID #: NRA 6290010
• Secondary ID: EudraCT No: 2006
• Status: Recruiting
• Phase: Phase 4
• First received: October 31, 2007
• Last updated: September 23, 2010
• Start date: June 2006
• Est. completion date: December 2010

Study information

• Verified date: September 2010
• Source: University of Wuerzburg
• Contact: Gwendolyn Bender, MD
• Phone: 004993120139716
• Email: bender_g[@]medizin.uni-wuerzburg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acromegaly
• Heart Failure
• Hypertrophy
• Hypertrophy, Left Ventricular

Intervention

Drug:
• pegvisomant
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

Locations

Country	Name	City	State
Germany	University of Wuerzburg, Department of Endocrinology	Wuerzburg	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
University of Wuerzburg	Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI).		one year
Secondary	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