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

March 17, 2015 updated by: Karen Klahr Miller, MD, Massachusetts General Hospital

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Echocardiographic Findings at One Year
Time Frame: baseline and one year
baseline and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Karen K Miller, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 23, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010P002188

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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