AcromegalyNCT01302652
Effect of Growth Hormone (GH) on Cardiac Echos in GH Deficient Patients After Acromegaly Treatment
An observational study of Acromegaly, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to study the effects of growth hormone (GH) replacement on the heart. The investigators will study these effects in people who have been cured of acromegaly and then have developed growth hormone deficiency (GHD, not enough growth hormone). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acromegaly
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Feb 2015
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women between age 18-75 who have developed growth hormone deficiency after history of acromegaly with biochemical cure.
Who may be able to join
- age 18-75
- history of acromegaly with biochemical cure
- growth hormone deficiency
Who cannot join
- untreated thyroid disease within the past 3 months
- untreated adrenal insufficiency within the past 3 months
- uncontrolled hypertension
- congestive heart failure
- gonadal steroid therapy within the past 3 months
- pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Effects of Physiologic Growth Hormone Administration on Echocardiographic Parameters in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly
The purpose of this research study is to study the effects of growth hormone (GH) replacement on the heart. The investigators will study these effects in people who have been cured of acromegaly and then have developed growth hormone deficiency (GHD, not enough growth hormone).
- Conditions
- Acromegaly
- Keywords
- acromegaly, growth hormone, growth hormone deficiency
- Medical subject headings
- Acromegaly, Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GH deficient after acromegaly cure (on GH replacement) | Men and women with growth hormone deficiency following cure of acromegaly who are receiving growth hormone treatment. | |
| GH deficient after acromegaly cure (not on GH replacement) | Men and women with growth hormone deficiency following cure of acromegaly who are not receiving growth hormone treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Echocardiographic Findings at One Year
Measured: baseline and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2015
- Study completionFeb 2015
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.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Klahr Miller, MD, Massachusetts General Hospital
- Investigators
- Karen K Miller, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302652
- Sponsor's protocol ID
- 2010P002188
- Status last verified
- Mar 2015
- First submitted
- 18 Feb 2011
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physiologic Growth Hormone Administration on Echocardiographic Parameters in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly
- ClinicalTrials.gov ID
- NCT01302652
- Acronym / sponsor ID
- 2010P002188
- Conditions
- Acromegaly
- Keywords
- acromegaly, growth hormone, growth hormone deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Feb 2011 (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 research study is to study the effects of growth hormone (GH) replacement on the heart. The investigators will study these effects in people who have been cured of acromegaly and then have developed growth hormone deficiency (GHD, not enough growth hormone).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH deficient after acromegaly cure (on GH replacement) | – | –Men and women with growth hormone deficiency following cure of acromegaly who are receiving growth hormone treatment. |
| GH deficient after acromegaly cure (not on GH replacement) | – | –Men and women with growth hormone deficiency following cure of acromegaly who are not receiving growth hormone treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women between age 18-75 who have developed growth hormone deficiency after history of acromegaly with biochemical cure.
Key inclusion criteria (3 listed)
- age 18-75
- history of acromegaly with biochemical cure
- growth hormone deficiency
Key exclusion criteria (6 listed)
- untreated thyroid disease within the past 3 months
- untreated adrenal insufficiency within the past 3 months
- uncontrolled hypertension
- congestive heart failure
- gonadal steroid therapy within the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in Echocardiographic Findings at One Year
Time frame: baseline and one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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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.
Karen K Miller, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Massachusetts General Hospital at 1 site in United States.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 18 Mar 2015. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Echocardiographic Findings at One Year (time frame: baseline and 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 18 Mar 2015.