Cardiovascular DiseasesNCT00005316
White Coat Hypertension and Antihypertensive Treatment Effect - SCOR in Hypertension
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate the mechanisms of white coat hypertension and study it further as a risk factor for heart damage. 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
- Dec 1985to Nov 1995
- 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 investigate the mechanisms of white coat hypertension and study it further as a risk factor for heart damage.
Read the detailed description
BACKGROUND:
The multidisciplinary SCOR examined causes, consequences, and treatments of human hypertension. A central theme was the renal basis for human hypertension. The subproject on white coat hypertension began in December of 1985.
DESIGN NARRATIVE:
In the longitudinal study, eighty patients with white coat hypertension were compared with 40 age- and sex-matched normotensives, and with 80 patients with sustained hypertension. The protocol consisted of (a) clinic blood pressure measurements made both by a physician and a nurse, (b) self-monitoring at home, (c) noninvasive ambulatory monitoring, (d) reactivity testing (cold pressor test, mental arithmetic, and isometric exercise) and (e) Korotkoff signal recording. Patients were also tested for early markers of disease (echocardiography and urine albumin).
The 80 patients in each of the two hypertensive groups were randomized to one of four treatment protocols (20 patients each); an alpha blocker, a beta blocker, a combined alpha- and beta-blocker, or an ACE inhibitor. The doses of medication were adjusted to produce similar reductions of clinic blood pressure in the different groups. The test battery (a-e) was reported during treatment.
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 startDec 1985
- Study completionNov 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- NCT00005316
- Sponsor's protocol ID
- 4086
- Other IDs
- P50HL018323
- Status last verified
- Aug 2001
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Liu JE, Roman MJ, Pini R, Schwartz JE, Pickering TG, Devereux RB. Cardiac and arterial target organ damage in adults with elevated ambulatory and normal office blood pressure. Ann Intern Med. 1999 Oct 19;131(8):564-72. doi: 10.7326/0003-4819-131-8-199910190-00003.
PubMed 10523216Cavallini MC, Roman MJ, Pickering TG, Schwartz JE, Pini R, Devereux RB. Is white coat hypertension associated with arterial disease or left ventricular hypertrophy? Hypertension. 1995 Sep;26(3):413-9. doi: 10.1161/01.hyp.26.3.413.
PubMed 7649575Pickering TG, Devereux RB, Gerin W, James GD, Pieper C, Schlussel YR, Schnall PL. The role of behavioral factors in white coat and sustained hypertension. J Hypertens Suppl. 1990 Dec;8(7):S141-7.
PubMed 2095382Pickering TG, James GD, Boddie C, Harshfield GA, Blank S, Laragh JH. How common is white coat hypertension? JAMA. 1988 Jan 8;259(2):225-8.
PubMed 3336140
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
- White Coat Hypertension and Antihypertensive Treatment Effect - SCOR in Hypertension
- ClinicalTrials.gov ID
- NCT00005316
- Acronym / sponsor ID
- 4086
- 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
- Dec 1985
- Study completion
- Nov 1995 (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 investigate the mechanisms of white coat hypertension and study it further as a risk factor for heart damage.
Detailed description
BACKGROUND:
The multidisciplinary SCOR examined causes, consequences, and treatments of human hypertension. A central theme was the renal basis for human hypertension. The subproject on white coat hypertension began in December of 1985.
DESIGN NARRATIVE:
In the longitudinal study, eighty patients with white coat hypertension were compared with 40 age- and sex-matched normotensives, and with 80 patients with sustained hypertension. The protocol consisted of (a) clinic blood pressure measurements made both by a physician and a nurse, (b) self-monitoring at home, (c) noninvasive ambulatory monitoring, (d) reactivity testing (cold pressor test, mental arithmetic, and isometric exercise) and (e) Korotkoff signal recording. Patients were also tested for early markers of disease (echocardiography and urine albumin).
The 80 patients in each of the two hypertensive groups were randomized to one of four treatment protocols (20 patients each); an alpha blocker, a beta blocker, a combined alpha- and beta-blocker, or an ACE inhibitor. The doses of medication were adjusted to produce similar reductions of clinic blood pressure in the different groups. The test battery (a-e) was reported during treatment.
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 10523216Liu JE, Roman MJ, Pini R, Schwartz JE, Pickering TG, Devereux RB. Cardiac and arterial target organ damage in adults with elevated ambulatory and normal office blood pressure. Ann Intern Med. 1999 Oct 19;131(8):564-72. doi: 10.7326/0003-4819-131-8-199910190-00003.
- Background: PubMed 7649575Cavallini MC, Roman MJ, Pickering TG, Schwartz JE, Pini R, Devereux RB. Is white coat hypertension associated with arterial disease or left ventricular hypertrophy? Hypertension. 1995 Sep;26(3):413-9. doi: 10.1161/01.hyp.26.3.413.
- Background: PubMed 2095382Pickering TG, Devereux RB, Gerin W, James GD, Pieper C, Schlussel YR, Schnall PL. The role of behavioral factors in white coat and sustained hypertension. J Hypertens Suppl. 1990 Dec;8(7):S141-7.
- Background: PubMed 3336140Pickering TG, James GD, Boddie C, Harshfield GA, Blank S, Laragh JH. How common is white coat hypertension? JAMA. 1988 Jan 8;259(2):225-8.
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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 NCT00005316, which also lists 4 linked publications.
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.