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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Wuerzburg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT00552851
First received: October 31, 2007
Last updated: September 23, 2010
Last verified: September 2010
  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.


Condition Intervention Phase
Acromegaly
Heart Failure
Hypertrophy, Left Ventricular
Drug: pegvisomant
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Wuerzburg:

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

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 [ Time Frame: one year ]

Estimated Enrollment: 4
Study Start Date: June 2006
Estimated Study Completion Date: December 2010
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552851

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

No publications provided

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
Study First Received: October 31, 2007
Last Updated: September 23, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Wuerzburg:
acromegaly
heart failure
hypertrophy
cardiomegaly

Additional relevant MeSH terms:
Acromegaly
Heart Failure
Hypertrophy
Hypertrophy, Left Ventricular
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly

ClinicalTrials.gov processed this record on September 14, 2014