Cardiovascular DiseasesNCT00005417
Fifteen Year Follow-up of 5,500 Black and 5,500 Other Hypertensives
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To seek predictors of mortality, hospitalization, and dialysis using data from a hypertensive population which began treatment in 1974. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1991to Sep 1993
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To seek predictors of mortality, hospitalization, and dialysis using data from a hypertensive population which began treatment in 1974.
Read the detailed description
DESIGN NARRATIVE:
Patients dying before 1989 were identified using the VA's Beneficiary Identification Records Location Subsystem and the National Death Index (NDI). Using NDI information to locate them, death certificates were obtained on all dead patients. Arrangements were made to collect data on the VA hospitalizations occurring after antihypertensive treatment had begun, and application was made to match patients against the USRDS Dialysis and Transplant Registry. The basic clinical data were collected in 32 VA Hypertension Screening and Treatment Program (HSTP) clinics during the 40 month period beginning in 1974. Approximately 30,000 completed Screening and Evaluation Forms and 75,000 Treatment Visit Forms were completed during the 40 months of data collection. The collected information was entered into the HSTP Master File at the VA Computer Center in Austin, Texas. Predictors were sought for (1) all-cause mortality, (2) cause-specific mortality (obtained from death certificates and hospitalization and clinic records), (3) endstage renal disease (obtained from the USRDS Dialysis and Transplant Registry), (4) VA hospital usage combined with other data related to cost care.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension, Kidney Failure, Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1991
- Study completionSep 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005417
- Sponsor's protocol ID
- 4335
- Other IDs
- R03HL047677
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Perry HM Jr, Miller JP, Fornoff JR, Baty JD, Sambhi MP, Rutan G, Moskowitz DW, Carmody SE. Early predictors of 15-year end-stage renal disease in hypertensive patients. Hypertension. 1995 Apr;25(4 Pt 1):587-94. doi: 10.1161/01.hyp.25.4.587.
PubMed 7721402
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fifteen Year Follow-up of 5,500 Black and 5,500 Other Hypertensives
- ClinicalTrials.gov ID
- NCT00005417
- Acronym / sponsor ID
- 4335
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1991
- Study completion
- Sep 1993 (actual)
- First posted
- 26 May 2000 (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.
To seek predictors of mortality, hospitalization, and dialysis using data from a hypertensive population which began treatment in 1974.
Detailed description
DESIGN NARRATIVE:
Patients dying before 1989 were identified using the VA's Beneficiary Identification Records Location Subsystem and the National Death Index (NDI). Using NDI information to locate them, death certificates were obtained on all dead patients. Arrangements were made to collect data on the VA hospitalizations occurring after antihypertensive treatment had begun, and application was made to match patients against the USRDS Dialysis and Transplant Registry. The basic clinical data were collected in 32 VA Hypertension Screening and Treatment Program (HSTP) clinics during the 40 month period beginning in 1974. Approximately 30,000 completed Screening and Evaluation Forms and 75,000 Treatment Visit Forms were completed during the 40 months of data collection. The collected information was entered into the HSTP Master File at the VA Computer Center in Austin, Texas. Predictors were sought for (1) all-cause mortality, (2) cause-specific mortality (obtained from death certificates and hospitalization and clinic records), (3) endstage renal disease (obtained from the USRDS Dialysis and Transplant Registry), (4) VA hospital usage combined with other data related to cost care.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 13 May 2016.
- Background: PubMed 7721402Perry HM Jr, Miller JP, Fornoff JR, Baty JD, Sambhi MP, Rutan G, Moskowitz DW, Carmody SE. Early predictors of 15-year end-stage renal disease in hypertensive patients. Hypertension. 1995 Apr;25(4 Pt 1):587-94. doi: 10.1161/01.hyp.25.4.587.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 May 2016. 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?
On the ClinicalTrials.gov record for NCT00005417, which also lists 1 linked publication.
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 13 May 2016.