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CompletedNCT00005363Updated May 13, 2016

Ambulatory Blood Pressure and Prognosis

An observational study in Cardiovascular Diseases, Heart Diseases and Hypertension, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed. Open to male participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2016-05-13.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Ages
Up to 100 Years
Sex
Male
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Study summary

To continue a prospective study of the ability of ambulatory blood pressure to predict cardiovascular morbidity in patients with mild hypertension.

Read the detailed description

BACKGROUND:

This was a continuation of a prospective study of the ability of ambulatory blood pressure to predict cardiovascular morbidity in patients with mild hypertension, which was first started in 1978.

DESIGN NARRATIVE:

Predictor variables evaluated at entry to the longitudinal study included clinic and ambulatory blood pressures (including measures of pressure level and variability in different settings), left ventricular mass index (LVMI, determined by echocardiography), renin-sodium profile, and other cardiovascular risk factors (e.g., cholesterol and smoking). During follow-up, blood pressure, treatment status, BMI, and clinical course were evaluated. Outcome measures were definite cardiovascular morbid events, defined as sudden cardiac death, myocardial infarction, stroke, congestive heart failure, and coronary artery revascularization. The main hypotheses tested were that ambulatory blood pressure would give a better prediction of outcome than clinic pressure, and that patients with white coat hypertension (defined as a high clinic pressure and normal ambulatory pressure) would be at low risk relative to patients with sustained hypertension. Initial results in 729 patients initially studied between 1978 and 1985 using Cox survival analysis showed that the four most significant predictors of morbid events were daytime blood pressure variability, age, male sex, and serum cholesterol. Patients with white coat hypertension appeared to be at a level of risk intermediate between normotensives and sustained hypertensives, but the differences were not yet significant. Expansion of the cohort size to include patients evaluated initially between 1985 and 1990 provided nearly 2,000 patients altogether, which together with the longer follow-up of the initial cohort provided a sufficient number of morbid events to identify the predictive significance of the different blood pressure measures, and their interaction with other risk factors.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

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Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
  • Hypertension
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

Browse Cardiovascular Diseases studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

No eligibility criteria

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Study design

06

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Loupal G. [Gastrolithiasis in a llama]. Berl Munch Tierarztl Wochenschr. 1982 Jan 1;95(1):14-6. No abstract available. German. PubMed 7059338 ↗
  • James GD, Toledano T, Datz G, Pickering TG. Factors influencing the awake-sleep difference in ambulatory blood pressure: main effects and sex differences. J Hum Hypertens. 1995 Oct;9(10):821-6. PubMed 8576898 ↗
  • Devereux RB, de Simone G, Ganau A, Roman MJ. Left ventricular hypertrophy and geometric remodeling in hypertension: stimuli, functional consequences and prognostic implications. J Hypertens Suppl. 1994 Dec;12(10):S117-27. PubMed 7769482 ↗
  • Devereux RB, Roman MJ, Ganau A, de Simone G, Okin PM, Kligfield P. Cardiac and arterial hypertrophy and atherosclerosis in hypertension. Hypertension. 1994 Jun;23(6 Pt 1):802-9. doi: 10.1161/01.hyp.23.6.802. PubMed 8206580 ↗
  • Devereux RB, James GD, Pickering TG. What is normal blood pressure? Comparison of ambulatory pressure level and variability in patients with normal or abnormal left ventricular geometry. Am J Hypertens. 1993 Jun;6(6 Pt 2):211S-215S. PubMed 8347321 ↗
  • Pickering TG, James GD. Determinants and consequences of the diurnal rhythm of blood pressure. Am J Hypertens. 1993 Jun;6(6 Pt 2):166S-169S. doi: 10.1093/ajh/6.6.166s. PubMed 8347311 ↗
  • Devereux RB. Left ventricular geometry, pathophysiology and prognosis. J Am Coll Cardiol. 1995 Mar 15;25(4):885-7. doi: 10.1016/0735-1097(94)00547-4. No abstract available. PubMed 7884092 ↗
  • Pickering TG, James GD. Ambulatory blood pressure and prognosis. J Hypertens Suppl. 1994 Nov;12(8):S29-33. PubMed 7707152 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00005363
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
First posted
May 26, 2000
Start date
Aug 1992
Completion
Jul 1994
Last update
May 13, 2016
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2000. You cannot join it, but the record below documents what was studied.

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