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Effect of Growth Hormone (GH) on Cardiac Echos in GH Deficient Patients After Acromegaly Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01302652
First received: February 18, 2011
Last updated: February 4, 2014
Last verified: February 2014

February 18, 2011
February 4, 2014
February 2011
June 2014   (final data collection date for primary outcome measure)
Change from Baseline in Echocardiographic Findings at One Year [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01302652 on ClinicalTrials.gov Archive Site
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Effect of Growth Hormone (GH) on Cardiac Echos in GH Deficient Patients After Acromegaly Treatment
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).

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum and plasma

Non-Probability Sample

Men and women between age 18-75 who have developed growth hormone deficiency after history of acromegaly with biochemical cure.

Acromegaly
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
Not Provided
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 18-75
  • history of acromegaly with biochemical cure
  • growth hormone deficiency

Exclusion Criteria:

  • 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01302652
2010P002188
No
Karen Klahr Miller, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Karen K Miller, MD Massachusetts General Hospital
Massachusetts General Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP