Effect of Growth Hormone (GH) on Cardiac Echos in GH Deficient Patients After Acromegaly Treatment
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
First received: February 18, 2011
Last updated: February 4, 2014
Last verified: February 2014
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).
||Observational Model: Case Control
Time Perspective: Prospective
||Effects of Physiologic Growth Hormone Administration on Echocardiographic Parameters in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly
Biospecimen Retention: Samples Without DNA
Primary Outcome Measures:
- Change from Baseline in Echocardiographic Findings at One Year [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Men and women between age 18-75 who have developed growth hormone deficiency after history of acromegaly with biochemical cure.
- age 18-75
- history of acromegaly with biochemical cure
- growth hormone deficiency
- 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302652
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
Massachusetts General Hospital
||Karen K Miller, MD
||Massachusetts General Hospital
No publications provided
||Karen Klahr Miller, MD, Principal Investigator, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 18, 2011
||February 4, 2014
||United States: Institutional Review Board
Keywords provided by Massachusetts General Hospital:
growth hormone deficiency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Bone Diseases, Endocrine
Central Nervous System Diseases
Endocrine System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs