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

Phase 4

• Conditions: Acromegaly; Heart Failure; Hypertrophy, Left Ventricular
• Interventions: Drug: pegvisomant

• Registration Number: NCT00552851
• Lead Sponsor: University of Wuerzburg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-10-31
• Study First Submitted QC: 2007-11-01
• Study First Posted: 2007-11-02
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-23
• Last Update Posted: 2010-09-24
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pegvisomant	pegvisomant	patients with active acromegaly and impaired cardiac function

Primary Outcome Measures

Name	Time	Method
Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI).	one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Wuerzburg, Department of Endocrinology; 🇩🇪 Wuerzburg, Bavaria, Germany