- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000474
Prevention and Treatment of Hypertension Study (PATHS)
Study Overview
Status
Intervention / Treatment
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 participant's 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 Type
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
Collaborators and Investigators
Publications and helpful links
General Publications
- Cushman WC, Cutler JA, Bingham SF, Harford T, Hanna E, Dubbert P, Collins JF, Dufour M, Follman D, Allender PS. Prevention and Treatment of Hypertension Study (PATHS). Rationale and design. Am J Hypertens. 1994 Sep;7(9 Pt 1):814-23. doi: 10.1093/ajh/7.9.814.
- Cushman WC, Cutler JA, Hanna E, Bingham SF, Harford T, Allender S, Follman D, Kirk G, Walsh S for the PATHS Group. The Prevention and Treatment of Hypertension Study (PATHS) primary results: effects of an alcohol treatment program on blood pressure. 36th Annual Conference on Cardiovascular Disease Epidemiology and Prevention (Abstract)
- Cushman WC, Cutler JA, Hanna E, Bingham SF, Follmann D, Harford T, Dubbert P, Allender PS, Dufour M, Collins JF, Walsh SM, Kirk GF, Burg M, Felicetta JV, Hamilton BP, Katz LA, Perry HM Jr, Willenbring ML, Lakshman R, Hamburger RJ. Prevention and Treatment of Hypertension Study (PATHS): effects of an alcohol treatment program on blood pressure. Arch Intern Med. 1998 Jun 8;158(11):1197-207. doi: 10.1001/archinte.158.11.1197.
- Bulpitt CJ, Shipley MJ. Failure of alcohol reduction to lower blood pressure in the PATHS trial. Prevention and Treatment of Hypertension Study. Arch Intern Med. 1999 Jan 25;159(2):195-6. doi: 10.1001/archinte.159.2.195. No abstract available.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 63
Plan for Individual participant data (IPD)
Study Data/Documents
-
Individual Participant Data Set
Information identifier: PATHSInformation comments: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
- Study Protocol
- Manual of Procedures
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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