Prevention and Treatment of Hypertension Study (PATHS)

Phase 3

Completed

• Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

• Registration Number: NCT00000474
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

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 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 Timeline

• Study Start: 1989-09
• Study Completion: 1994-09
• Study First Submitted: 1999-10-27
• Study First Submitted QC: 1999-10-27
• Study First Posted: 1999-10-28
• Status Verified: 2001-06
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified