Ambulatory Blood Pressure and Prognosis

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005363
• Other study ID #: 4250
• Secondary ID: R01HL048945
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: May 12, 2016
• Start date: August 1992
• Est. completion date: July 1994

Study information

• Verified date: April 2000
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 1994
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Hypertension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Devereux RB. Left ventricular geometry, pathophysiology and prognosis. J Am Coll Cardiol. 1995 Mar 15;25(4):885-7. Review. — View Citation

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. — View Citation

Loupal G. [Gastrolithiasis in a llama]. Berl Munch Tierarztl Wochenschr. 1982 Jan 1;95(1):14-6. German. — View Citation

Pickering TG, James GD. Ambulatory blood pressure and prognosis. J Hypertens Suppl. 1994 Nov;12(8):S29-33. Review. — View Citation

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. Review. — View Citation