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

NCT00552851

Last updated date
Study Location
University of Wuerzburg, Department of Endocrinology
Wuerzburg, Bavaria, 97080, Germany
Contact
004993120139716

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acromegaly, Heart Failure, Left Ventricular Hypertrophy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Acromegaly, Heart Failure, Left Ventricular HypertrophyChanges of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant
NCT00552851
  1. Wuerzburg, Bavaria
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acromegaly
  • Heart Failure
  • Hypertrophy, Left Ventricular
Intervention  ICMJE 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
Study Arms  ICMJE Pegvisomant
patients with active acromegaly and impaired cardiac function
Intervention: Drug: pegvisomant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 1, 2007)
4
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00552851
Other Study ID Numbers  ICMJE NRA 6290010
EudraCT No: 2006-001108-35
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Bruno Allolio, Department of Endocrinology
Study Sponsor  ICMJE University of Wuerzburg
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Bruno Allolio, MDUniversity of Wuerzburg. Department of Endocrinology
PRS Account University of Wuerzburg
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP