Prevention and Treatment of Hypertension Study (PATHS)

NCT ID: NCT00000474

Last Updated: 2016-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1989-09-30
• Study Completion Date: 1994-09-30

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).

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: PREVENTION

Interventions

behavior therapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

References

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.

Reference Type: BACKGROUND

PMID: 7811440 (View on PubMed)

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)

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 9625399 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9927105 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

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.

View Document

Document Type: Study Protocol

View Document

Document Type: Manual of Procedures

View Document

Other Identifiers

63

Identifier Type: -

Identifier Source: org_study_id