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Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT00552851 (opens ClinicalTrials.gov in a new tab)Other idNRA 6290010Other idEudraCT No: 2006-001108-35

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
4 participants (estimated)
Sponsor
University of Wuerzburg · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Germany

Start
Jun 2006
Primary completion
Not stated
Completion
Dec 2010 (estimated)
First posted
2 Nov 2007 (estimated)
Last update posted
24 Sept 2010 (estimated)
Conditions
Acromegaly · Heart Failure · Hypertrophy, Left Ventricular

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008200920102011
  1. Ph 4

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

    NCT00552851

    Jun 2006 to est. Dec 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • pegvisomantDrug

Arms1

  • Other

    Pegvisomant

    patients with active acromegaly and impaired cardiac function

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI).

    Time frame · one year

Secondary outcomes(1)
  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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