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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Acromegaly; Heart Failure; Hypertrophy, Left Ventricular	Drug: pegvisomant	Phase 4

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	4 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	June 2006
Estimated Study Completion Date :	December 2010

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Pegvisomant; patients with active acromegaly and impaired cardiac function	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; Other Name: Somavert

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI). [ Time Frame: one year ]

Secondary Outcome Measures :

1. 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 [ Time Frame: one year ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Gwendolyn Bender, MD	004993120139716	bender_g@medizin.uni-wuerzburg.de
Contact: Bruno Allolio, MD	004993120139020	allolio_b@medizin.uni-wuerzburg.de

Locations

Germany
University of Wuerzburg, Department of Endocrinology	Recruiting
Wuerzburg, Bavaria, Germany, 97080
Contact: Gwendolyn Bender, MD 004993120139716 bender_g@medizin.uni-wuerzburg.de

Sponsors and Collaborators

University of Wuerzburg

Pfizer

Investigators

Principal Investigator:	Bruno Allolio, MD	University of Wuerzburg. Department of Endocrinology

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Prof. Bruno Allolio, Department of Endocrinology
ClinicalTrials.gov Identifier:	NCT00552851 History of Changes
Other Study ID Numbers:	NRA 6290010; EudraCT No: 2006-001108-35
First Posted:	November 2, 2007
Last Update Posted:	September 24, 2010
Last Verified:	September 2010

Keywords provided by University of Wuerzburg:

acromegaly; heart failure; hypertrophy; cardiomegaly

Additional relevant MeSH terms:

Heart Failure; Hypertrophy; Acromegaly; Hypertrophy, Left Ventricular; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism	Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Cardiomegaly; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs