Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000474
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
1999-10-27
Brief Title:
Prevention and Treatment of Hypertension Study PATHS
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:
2001-06
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 evaluate the long-term effect of reduction of alcohol intake on blood pressure in moderate but non-dependent drinkers with mild hypertension or high normal blood pressure
Detailed Description:
BACKGROUND
Numerous observational epidemiologic studies have established ethanol intake as one of the most important determinants of blood pressure levels However data from intervention studies were very limited
The study was an inter-agency agreement involving the Veterans Administration and the National Institute on Alcohol Abuse and Alcoholism NIAAA Protocol development occurred between October 1988 and June 1989 The protocol was approved by the VA Cooperative Studies Evaluation Committee in July 1989 and reviewed by a separate Data and Safety Monitoring Board in September 1989
DESIGN NARRATIVE
Subjects were randomized to intervention or control groups Intervention aimed to reduce alcohol intake to no more than 14 drinks per week and 50 percent or less of each participants baseline level The intervention technique consisted of a cognitive-behavioral program the intensive phase of which consisted of six counseling sessions over three months Echocardiograms were obtained at baseline and six months after randomization Biochemical markers were used to validate changes in alcohol consumption The trial included an eighteen-month feasibility phase with six-month follow-up and a 36-month main trial with two years of follow-up Recruitment for the full-scale trial ended in June 1993 Final study visits were conducted in September and October 1994
The study completion date listed in this record was obtained from the End Date entered in the Query View Report System QVR
Numerous observational epidemiologic studies have established ethanol intake as one of the most important determinants of blood pressure levels However data from intervention studies were very limited
The study was an inter-agency agreement involving the Veterans Administration and the National Institute on Alcohol Abuse and Alcoholism NIAAA Protocol development occurred between October 1988 and June 1989 The protocol was approved by the VA Cooperative Studies Evaluation Committee in July 1989 and reviewed by a separate Data and Safety Monitoring Board in September 1989
DESIGN NARRATIVE
Subjects were randomized to intervention or control groups Intervention aimed to reduce alcohol intake to no more than 14 drinks per week and 50 percent or less of each participants baseline level The intervention technique consisted of a cognitive-behavioral program the intensive phase of which consisted of six counseling sessions over three months Echocardiograms were obtained at baseline and six months after randomization Biochemical markers were used to validate changes in alcohol consumption The trial included an eighteen-month feasibility phase with six-month follow-up and a 36-month main trial with two years of follow-up Recruitment for the full-scale trial ended in June 1993 Final study visits were conducted in September and October 1994
The study completion date listed in this record was obtained from the End Date entered in the Query View Report System QVR
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?: