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

NCT00552851 | Unknown Phase 4 DMC

• 2 other identifiers: NRA 6290010EudraCT No: 2006-001108-35
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly; Heart Failure; Hypertrophy, Left Ventricular

Keywords

acromegaly; heart failure; hypertrophy; cardiomegaly

Outcome Measures

Primary Outcomes (1)

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

  one year

Secondary Outcomes (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

  one year

Study Arms (1)

Pegvisomant

OTHER

patients with active acromegaly and impaired cardiac function

Drug: pegvisomant

Interventions

pegvisomant DRUG

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

Also known as: Somavert

Pegvisomant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Wuerzburg: lead
• Pfizer: collaborator

Study Sites (1)

University of Wuerzburg, Department of Endocrinology

Würzburg, Bavaria, 97080, Germany

RECRUITING

MeSH Terms

Conditions

Acromegaly; Heart Failure; Hypertrophy, Left Ventricular; Hypertrophy; Cardiomegaly

Interventions

pegvisomant

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruno Allolio, MD

  University of Wuerzburg. Department of Endocrinology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwendolyn Bender, MD

CONTACT

004993120139716; bender_g@medizin.uni-wuerzburg.de

Bruno Allolio, MD

CONTACT

004993120139020; allolio_b@medizin.uni-wuerzburg.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 2, 2007
• Study Start: June 1, 2006
• Study Completion: December 1, 2010
• Last Updated: September 24, 2010

Record last verified: 2010-09

Locations

DE (1)