Cardiac Function and Morphology Evaluated by Magnetic Res... | NCT00970463

Studies
Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly

NCT00970463

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

Sep 2, 2009Estimated

Enrollment

22Actual

Phase

Not provided

Conditions

Growth Hormone Deficiency
Cardiac Function

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Sep 1, 2009

First Submission Date that Met QC Criteria

Sep 1, 2009

First Posted Date

Sep 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2009

Last Update Posted Date

Sep 2, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To test the hypothesis that both lack and excess of growth hormone (GH) is associated with cardiac abnormalities. Cardiac function and morphology will be evaluated by MRI before and after treatment.

Detailed Description

It is an open prospective noninterventional clinical study. Treatment and follow-up will be according to usual guidelines, and will be unaffected by inclusion in the study. GHD patients will be treated with daily subcutaneous GH injections. Patients with acromegaly will be treated with either transsphenoidal surgery or by medical treatment with long acting somatostatin analogues, dopamine agonist, GH antagonist or combinations of these treatment modalities.

Patients will be examined by Cardiac MRI before treatment and after one year of treatment.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GH		Patients with GHD
Pegvisomant and Somatostatin analogues		Acromegaly

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in cardiac function i relation to changes in the activity of the GH-axis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Peak GH below 6.0 ng/mL during Pyridostigmine-GHRH test.
Nadir GH above 0.4 ng/mL and elevated levels of IGF-I during oral glucose tolerance test

Exclusion Criteria:

Contraindications for magnetic resonance scan

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with GHD based on an insufficient stimulation of GH-secretion during Pyridostigmin-GHRH test.

Patients with acromegaly based on an insufficient supression of GH-secretion during oral glucose tolerance test

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20730514	Derived	Andreassen M, Faber J, Kjaer A, Petersen CL, Kristensen LO. Cardiac function in growth hormone deficient patients before and after 1 year with replacement therapy: a magnetic resonance imaging study. Pituitary. 2011 Mar;14(1):1-10. doi: 10.1007/s11102-010-0250-7.

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases