Cardiovascular DiseasesNCT00005409
Longitudinal Studies of Blood Pressure in the Elderly
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To study further the association between blood pressure mortality among those who participated in both the Hypertension Detection and Follow-up Program (HDFP) screen and the East Boston Established Populations for Epidemiologic Studies in the Elderly (EPESE) study. 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
- May 1991to Apr 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 study further the association between blood pressure mortality among those who participated in both the Hypertension Detection and Follow-up Program (HDFP) screen and the East Boston Established Populations for Epidemiologic Studies in the Elderly (EPESE) study.
Read the detailed description
BACKGROUND:
In middle-age, level of blood pressure (BP) is a strong and independent predictor of both total and cardiovascular disease (CVD) mortality. However, among the elderly, recent short-term observational studies, including the East Boston Established Populations for Epidemiologic Studies in the Elderly (EPESE), have raised the possibility of a J-shaped curve. In a study of short-term mortality, low blood pressures were positively associated with total and cardiovascular disease mortality. However, a further analysis confined to the 2079 (68 percent) of this cohort who were also screened nine years previously for the Hypertension Detection and Follow-Up Program showed the more conventional positive linear relationship between systolic blood pressure, and no association between diastolic blood pressure and mortality. The observations of higher short-term total and cardiovascular disease mortality at lower blood pressure levels among the elderly could have reflected a particular susceptibility to deleterious consequences of drug therapy for high blood pressure. Alternatively, such a finding might have been artifactual, due to survival bias or confounding by co-morbid conditions.
DESIGN NARRATIVE:
Linking data from the HDFP and the EPESE studies, the investigators examined change in blood pressure, antihypertensive medication use, and mortality over a 15-year period. With regard to the association between lower blood pressure and increased mortality, they determined whether the relationship previously observed reflected a fall from normotensive levels as opposed to a consistently low blood pressure. With regard to the upper end of the mortality curve, they assessed the effect of antihypertensive drug treatment on mortality as compared to those with untreated hypertension. The latter question had particular public health significance because questions remained about the risk-to-benefit ratio of antihypertensive drug treatment in this age group. Furthermore, they also described changes in blood pressure in this population and medication usage patterns over time and correlated type of medication and mortality.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
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 startMay 1991
- Study completionApr 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
- NCT00005409
- Sponsor's protocol ID
- 4327
- Other IDs
- R03HL046923
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Glynn RJ, Field TS, Satterfield S, Hebert PR, Buring JE, Taylor JO, Hennekens CH. Modification of increasing systolic blood pressure in the elderly during the 1980s. Am J Epidemiol. 1993 Sep 15;138(6):365-79. doi: 10.1093/oxfordjournals.aje.a116869.
PubMed 8213742
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Studies of Blood Pressure in the Elderly
- ClinicalTrials.gov ID
- NCT00005409
- Acronym / sponsor ID
- 4327
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 1991
- Study completion
- Apr 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 study further the association between blood pressure mortality among those who participated in both the Hypertension Detection and Follow-up Program (HDFP) screen and the East Boston Established Populations for Epidemiologic Studies in the Elderly (EPESE) study.
Detailed description
BACKGROUND:
In middle-age, level of blood pressure (BP) is a strong and independent predictor of both total and cardiovascular disease (CVD) mortality. However, among the elderly, recent short-term observational studies, including the East Boston Established Populations for Epidemiologic Studies in the Elderly (EPESE), have raised the possibility of a J-shaped curve. In a study of short-term mortality, low blood pressures were positively associated with total and cardiovascular disease mortality. However, a further analysis confined to the 2079 (68 percent) of this cohort who were also screened nine years previously for the Hypertension Detection and Follow-Up Program showed the more conventional positive linear relationship between systolic blood pressure, and no association between diastolic blood pressure and mortality. The observations of higher short-term total and cardiovascular disease mortality at lower blood pressure levels among the elderly could have reflected a particular susceptibility to deleterious consequences of drug therapy for high blood pressure. Alternatively, such a finding might have been artifactual, due to survival bias or confounding by co-morbid conditions.
DESIGN NARRATIVE:
Linking data from the HDFP and the EPESE studies, the investigators examined change in blood pressure, antihypertensive medication use, and mortality over a 15-year period. With regard to the association between lower blood pressure and increased mortality, they determined whether the relationship previously observed reflected a fall from normotensive levels as opposed to a consistently low blood pressure. With regard to the upper end of the mortality curve, they assessed the effect of antihypertensive drug treatment on mortality as compared to those with untreated hypertension. The latter question had particular public health significance because questions remained about the risk-to-benefit ratio of antihypertensive drug treatment in this age group. Furthermore, they also described changes in blood pressure in this population and medication usage patterns over time and correlated type of medication and mortality.
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 16 Mar 2016.
- Background: PubMed 8213742Glynn RJ, Field TS, Satterfield S, Hebert PR, Buring JE, Taylor JO, Hennekens CH. Modification of increasing systolic blood pressure in the elderly during the 1980s. Am J Epidemiol. 1993 Sep 15;138(6):365-79. doi: 10.1093/oxfordjournals.aje.a116869.
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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 16 Mar 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 NCT00005409, 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 16 Mar 2016.