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Study of Heart Effects When Growth Hormone (GH) is Used for Growth Hormone Deficiency (GHD) Following Cure of Acromegaly (AcroGHD)

This study is currently recruiting participants.
Verified October 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01302652
First received: February 18, 2011
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

Having too little or too much GH are both associated with heart disease.

The purpose of this research study is to study the effects of growth hormone (GH) replacement on the heart. We 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 Intervention
Acromegaly
 Procedure: echocardiogram

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:

Drug Information available for: Somatropin
U.S. FDA Resources

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: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
AcroGHD on GH
Men and women with growth hormone deficiency following cure of acromegaly who are receiving growth hormone treatment.
 Procedure: echocardiogram
An echocardiogram will be performed in all subjects at baseline and at one year.
AcroGHD not on GH
Men and women with growth hormone deficiency following cure of acromegaly who are not receiving growth hormone treatment.
 Procedure: echocardiogram
An echocardiogram will be performed in all subjects at baseline and at one year.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302652

Contacts
Contact: Eleanor Lin, MD 617-726-3897
Contact: Neuroendocrine Unit 617-726-3870

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Eleanor Lin, MD     617-726-3870        
Sub-Investigator: Eleanor Lin, MD            
Principal Investigator: Karen K Miller, MD            
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: October 24, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013