Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant
Primary Purpose
Acromegaly, Heart Failure, Hypertrophy, Left Ventricular
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
pegvisomant
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring acromegaly, heart failure, hypertrophy, cardiomegaly
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
- 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
Sites / Locations
- University of Wuerzburg, Department of EndocrinologyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pegvisomant
Arm Description
patients with active acromegaly and impaired cardiac function
Outcomes
Primary Outcome Measures
Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI).
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00552851
First Posted
October 31, 2007
Last Updated
September 23, 2010
Sponsor
University of Wuerzburg
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00552851
Brief Title
Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant
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 Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Wuerzburg
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly, Heart Failure, Hypertrophy, Left Ventricular
Keywords
acromegaly, heart failure, hypertrophy, cardiomegaly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pegvisomant
Arm Type
Other
Arm Description
patients with active acromegaly and impaired cardiac function
Intervention Type
Drug
Intervention Name(s)
pegvisomant
Other Intervention Name(s)
Somavert
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI).
Time Frame
one year
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gwendolyn Bender, MD
Phone
004993120139716
Email
bender_g@medizin.uni-wuerzburg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Allolio, MD
Phone
004993120139020
Email
allolio_b@medizin.uni-wuerzburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Allolio, MD
Organizational Affiliation
University of Wuerzburg. Department of Endocrinology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wuerzburg, Department of Endocrinology
City
Wuerzburg
State/Province
Bavaria
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwendolyn Bender, MD
Phone
004993120139716
Email
bender_g@medizin.uni-wuerzburg.de
12. IPD Sharing Statement
Learn more about this trial
Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant
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