Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00552851 |
Recruitment Status : Unknown
Verified September 2010 by University of Wuerzburg.
Recruitment status was: Recruiting
First Posted : November 2, 2007
Last Update Posted : September 24, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acromegaly Heart Failure Hypertrophy, Left Ventricular | Drug: pegvisomant | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 4 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | June 2006 |
Estimated Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
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 |
- Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI). [ Time Frame: one year ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552851
Contact: Gwendolyn Bender, MD | 004993120139716 | bender_g@medizin.uni-wuerzburg.de | |
Contact: Bruno Allolio, MD | 004993120139020 | allolio_b@medizin.uni-wuerzburg.de |
Germany | |
University of Wuerzburg, Department of Endocrinology | Recruiting |
Wuerzburg, Bavaria, Germany, 97080 | |
Contact: Gwendolyn Bender, MD 004993120139716 bender_g@medizin.uni-wuerzburg.de |
Principal Investigator: | Bruno Allolio, MD | University of Wuerzburg. Department of Endocrinology |
Responsible Party: | Prof. Bruno Allolio, Department of Endocrinology |
ClinicalTrials.gov Identifier: | NCT00552851 |
Other Study ID Numbers: |
NRA 6290010 EudraCT No: 2006-001108-35 |
First Posted: | November 2, 2007 Key Record Dates |
Last Update Posted: | September 24, 2010 |
Last Verified: | September 2010 |
acromegaly heart failure hypertrophy cardiomegaly |
Acromegaly Heart Failure Hypertrophy, Left Ventricular Hypertrophy Heart Diseases Cardiovascular Diseases Pathological Conditions, Anatomical Bone Diseases, Endocrine Bone Diseases |
Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Cardiomegaly |