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Prevention and Treatment of Hypertension Study (PATHS)

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ClinicalTrials.gov Identifier: NCT00000474
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases Behavioral: behavior therapy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Prevention
Study Start Date : September 1989
Actual Study Completion Date : September 1994

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women with a diastolic blood pressure of 80 to 89 mm Hg and alcohol intake of 21 drinks or more per week.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: PATHS
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  This link exits the ClinicalTrials.gov site
Manual of Procedures  This link exits the ClinicalTrials.gov site

Publications:
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)

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ClinicalTrials.gov Identifier: NCT00000474    
Other Study ID Numbers: 63
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: June 2001
Additional relevant MeSH terms:
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Hypertension
Cardiovascular Diseases
Heart Diseases
Vascular Diseases