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
  Purpose

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).


Condition
Acromegaly

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Physiologic Growth Hormone Administration on Echocardiographic Parameters in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change from Baseline in Echocardiographic Findings at One Year [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum and plasma


Estimated Enrollment: 20
Study Start Date: February 2011
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
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

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Karen K Miller, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Karen Klahr Miller, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01302652     History of Changes
Other Study ID Numbers: 2010P002188
Study First Received: February 18, 2011
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
acromegaly
growth hormone
growth hormone deficiency

Additional relevant MeSH terms:
Dwarfism, Pituitary
Acromegaly
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014