Cardiovascular DiseasesNCT00442858
Incidence of Cardiovascular Diseases in Patients With Hypopituitarims
An observational study of Cardiovascular Diseases, run by Lund University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Dec 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed GH deficiency
Who cannot join
- Not confirmed GH deficiency
About this study
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.
- Conditions
- Cardiovascular Diseases
- Keywords
- cardiac disease, cerebrovascular disease, GH deficiency, diabetes mellitus, hypertension, GH therapy, GH deficiency and hypopituitarims
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Disorders, Dwarfism, Pituitary, Diabetes Mellitus, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startJan 1999
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 800 participants
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Eva Marie T Erfurth, MD, PhD, Principal investigator, Endocrine Unit, Department of Medicine, University Hospital, Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442858
- Sponsor's protocol ID
- LU-286-99
- Status last verified
- Mar 2007
- First submitted
- 1 Mar 2007
- Last updated
- 5 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Cardiovascular Diseases in Patients With Hypopituitarims
- ClinicalTrials.gov ID
- NCT00442858
- Acronym / sponsor ID
- LU-286-99
- Conditions
- Cardiovascular Diseases
- Keywords
- cardiac disease, cerebrovascular disease, GH deficiency, diabetes mellitus, hypertension, GH therapy, GH deficiency and hypopituitarims
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- Jan 1999
- Study completion
- Dec 2002
- First posted
- 5 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed GH deficiency
Key exclusion criteria (1 listed)
- Not confirmed GH deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Marie T Erfurth, MD, PhD principal investigator
Endocrine Unit, Department of Medicine, University Hospital, Lund
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Lund University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2007.