ClinicalTrials.gov processed this data on March 29, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT0000047463NCT00000474Prevention and Treatment of Hypertension Study (PATHS)National Heart, Lung, and Blood Institute (NHLBI)NIHNational Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
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.
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).
CompletedSeptember 1989September 1994Phase 3InterventionalNoRandomizedPreventionCardiovascular DiseasesHeart DiseasesHypertensionVascular DiseasesBehavioralbehavior therapy
Men and women with a diastolic blood pressure of 80 to 89 mm Hg and alcohol intake of 21
drinks or more per week.
All18 Years75 YearsNoCushman 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/7.9.814.7811440Cushman 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.158.11.1197.9625399Bulpitt 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.9927105June 2001October 27, 1999October 27, 1999October 28, 1999July 11, 2016July 11, 2016July 12, 2016HypertensionCardiovascular DiseasesHeart DiseasesVascular DiseasesPATHSIndividual Participant Data Sethttp://biolincc.nhlbi.nih.gov/studies/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 Protocolhttp://biolincc.nhlbi.nih.gov/studies/paths/Manual of Procedureshttp://biolincc.nhlbi.nih.gov/studies/paths/