NCT01302652

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

4 years

First QC Date

February 18, 2011

Last Update Submit

March 17, 2015

Conditions

Acromegaly

Keywords

acromegalygrowth hormonegrowth hormone deficiency

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Echocardiographic Findings at One Year

    baseline and one year

Study Arms (2)

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 Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

AcromegalyDwarfism, Pituitary

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesDwarfismBone Diseases, DevelopmentalHypopituitarism

Study Officials

  • Karen K Miller, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 24, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

US(1)