Study of Heart Effects When Growth Hormone (GH) is Used for Growth Hormone Deficiency (GHD) Following Cure of Acromegaly - Full Text View

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 May 2012 by Massachusetts General Hospital

First Received on February 18, 2011. Last Updated on May 10, 2012 History of Changes

Sponsor:	Massachusetts General Hospital
Information provided by (Responsible Party):	Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01302652

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:

Genetics Home Reference related topics: combined pituitary hormone deficiency isolated growth hormone deficiency metatropic dysplasia pseudoachondroplasia

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:	February 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:	May 10, 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 23, 2012