Incidence of Cardiovascular Diseases in Patients With Hyp... | NCT00442858

Studies
Incidence of Cardiovascular Diseases in Patients With Hypopituitarims

NCT00442858

Sponsor

Lund University Hospital

Status

Completed

Last Update Posted

Mar 5, 2007Estimated

Enrollment

800

Phase

Not provided

Conditions

Cardiovascular Diseases

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

Mar 2007

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 1999

Primary Completion Date

Not provided

Completion Date

Dec 2002

First Submitted Date

Mar 1, 2007

First Submission Date that Met QC Criteria

Mar 1, 2007

First Posted Date

Mar 5, 2007Estimated

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

Mar 1, 2007

Last Update Posted Date

Mar 5, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of the present study was therefore two-fold: 1) to make a retrospective comparison of incidence of non-fatal stroke and cardiac events between a large cohort of patients with confirmed GHD on replacement therapy (including GH) and a control cohort from the general population; 2) to compare the prevalence of DM and cardioprotective medication between the cohorts at the time of questionnaire distribution with adjustment for possible confounders and effect modifiers.

Detailed Description

Not provided

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

800

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed GH deficiency

Exclusion Criteria:

Not confirmed GH deficiency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Marie T Erfurth, MD, PhD	Endocrine Unit, Department of Medicine, University Hospital, Lund	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D002561	Cerebrovascular Disorders
D004393	Dwarfism, Pituitary
D003920	Diabetes Mellitus
D006973	Hypertension

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided