Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000498
Status:
COMPLETED
Last Update Posted:
2016-07-26
First Post:
1999-10-27
Brief Title:
Control of Hypertension by Non-Pharmacologic Means
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:
2000-01
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 determine whether blood pressure could be controlled by nutritional-hygienic non-pharmacologic means in hypertensives treated with drugs in the Hypertension Detection and Follow-up Trial HDFP
Detailed Description:
BACKGROUND
In the 1970s many studies had been conducted to control blood pressure in individuals maintained at normotensive levels by the use of weight control and sodium restriction without the concomitant use of anti-hypertensives The associations between weight sodium and blood pressure had been well established but data on the relationship of intervention to blood pressure control had been less so
DESIGN NARRATIVE
Patients were randomly assigned to one of three groups The 95 patients in Group I were advised to control weight reduce sodium intake modify dietary and alcohol intake and were removed from pharmacologic treatment The 44 patients in Group II were removed from pharmacologic treatment with no other intervention The 48 patients in Group III were continued on pharmacologic treatment with no other intervention The primary endpoint was the proportion in Groups I and II with diastolic blood pressure less than or equal to 90 mm Hg in the absence of antihypertensive drugs Secondary endpoints were average diastolic and systolic pressures
The study completion date listed in this record was obtained from the CRISP legacy data
In the 1970s many studies had been conducted to control blood pressure in individuals maintained at normotensive levels by the use of weight control and sodium restriction without the concomitant use of anti-hypertensives The associations between weight sodium and blood pressure had been well established but data on the relationship of intervention to blood pressure control had been less so
DESIGN NARRATIVE
Patients were randomly assigned to one of three groups The 95 patients in Group I were advised to control weight reduce sodium intake modify dietary and alcohol intake and were removed from pharmacologic treatment The 44 patients in Group II were removed from pharmacologic treatment with no other intervention The 48 patients in Group III were continued on pharmacologic treatment with no other intervention The primary endpoint was the proportion in Groups I and II with diastolic blood pressure less than or equal to 90 mm Hg in the absence of antihypertensive drugs Secondary endpoints were average diastolic and systolic pressures
The study completion date listed in this record was obtained from the CRISP legacy data
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 |
|---|---|---|---|
| R01HL024999 | NIH | None | httpsreporternihgovquickSearchR01HL024999 |