Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005363
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Ambulatory Blood Pressure and Prognosis
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To continue a prospective study of the ability of ambulatory blood pressure to predict cardiovascular morbidity in patients with mild hypertension
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 eg 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 2000 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
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 eg 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 2000 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL048945 | NIH | None | httpsreporternihgovquickSearchR01HL048945 |