AcromegalyPhase 4NCT00552851
Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant
A Phase 4 study testing pegvisomant in people with Acromegaly and Heart Failure, run by University of Wuerzburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly, Heart Failure, Hypertrophy, Left Ventricular
- What is being tested?
- pegvisomant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2006to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Wuerzburg, Department of Endocrinology
Würzburg, Bavaria, 97080
Gwendolyn Bender, MD, 004993120139716, bender_g@medizin.uni-wuerzburg.de
About this study
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
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
- Being tested
- pegvisomant
- Keywords
- acromegaly, heart failure, hypertrophy, cardiomegaly
- Medical subject headings
- Acromegaly, Heart Failure, Hypertrophy, Left Ventricular, Hypertrophy, Cardiomegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegvisomantDrug
Also called Somavert
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
| Study group | Role | What they receive |
|---|---|---|
| Pegvisomant | Other | patients with active acromegaly and impaired cardiac function Receives: Drug: pegvisomant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI).
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startJun 2006
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wuerzburg
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Bruno Allolio, MD, Principal investigator, University of Wuerzburg. Department of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552851
- Sponsor's protocol ID
- NRA 6290010
- Other IDs
- EudraCT No: 2006-001108-35
- Status last verified
- Sep 2010
- First submitted
- 31 Oct 2007
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00552851
- Acronym / sponsor ID
- NRA 6290010
- Conditions
- Acromegaly, Heart Failure, Hypertrophy, Left Ventricular
- Keywords
- acromegaly, heart failure, hypertrophy, cardiomegaly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- University of WuerzburgUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2006
- Study completion
- Dec 2010 (estimated)
- First posted
- 2 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegvisomant | Other | Drug: pegvisomantpatients with active acromegaly and impaired cardiac function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegvisomantAlso: Somavertbooster 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 | Drug | Pegvisomant |
Primary outcome
Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI).
Time frame: one year
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Allolio, MD principal investigator
University of Wuerzburg. Department of Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pegvisomant in people with Acromegaly and Heart Failure, run by University of Wuerzburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gwendolyn Bender, MD (004993120139716, bender_g@medizin.uni-wuerzburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI). (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2010.