Treatment of Mild Hypertension Study (TOMHS)

Sponsor

University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT00000522

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

105

Duration (Months)

Study Details

Study Description

Brief Summary

To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases	Behavioral: diet, sodium-restricted Behavioral: diet, reducing Behavioral: exercise Behavioral: alcohol restriction Drug: chlorthalidone Drug: acebutolol Drug: doxazosin Drug: amlodipine Drug: enalapril	Phase 2

Detailed Description

BACKGROUND:

Dietary sodium reduction has a mild effect on the reduction of hypertension. Weight loss, while achievable in the short-run with diet alone, may also have only mild effects on hypertension and is very difficult to maintain with diet and/or behavior modification. Alteration of patients' lifestyles to decrease excessive alcohol intake is somewhat controversial. Medications, on the other hand, have clear benefits in terms of blood pressure lowering, and in the case of diuretics and beta-blockers, reduction in cardiovascular morbidity and mortality. However, there is concern about their justified use in mild hypertension since each one has side effects, some of which may have long-term implications, such as alteration in serum lipids. Newer classes of drugs--calcium antagonists, angiotensin converting enzyme inhibitors, alpha blockers--had not previously been compared long-term with diuretics and beta-blockers.

DESIGN NARRATIVE:

TOMHS I enrolled 902 men and women to determine the feasibility of a larger trial. Participants were randomized in a double-blind manner to one of six treatment groups and within two strata. Stratum I was for participants not on antihypertensive drugs and Stratum

II for those on antihypertensive drugs at initial screening. There were six treatment arms:

placebo, a diuretic (chlorthalidone), a beta-adrenergic blocking agent (acebutolol), an alpha blocker (doxazosin mesylate), a calcium antagonist (amlodipine maleate), and an angiotensin converting enzyme inhibitor (enalapril maleate). All participants received a lifestyle intervention program that included reduction of sodium chloride and alcohol intake as well as weight reduction and increase in physical activity. All participants were followed for at least 48 months, with an average of 54 months. The primary endpoint was lowering of blood pressure. The treatments were also compared for effects on blood chemistries including lipoproteins, echocardiographic left ventricular mass, ventricular ectopic activity and ST-T changes of ischemia as measured by ambulatory ECG monitoring, side effects, and quality of life. Randomization took place between October 1986 and March 1988. Active follow-up ended in March-April 1992. Data analysis ended in May 1994.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

Study Start Date :

Aug 1, 1985

Study Completion Date :

May 1, 1994

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Men and women, ages 45 to 69, with mild hypertension (diastolic blood pressure of 90-99 mm Hg at two of three visits for untreated individuals. Patients who received drug therapy must have had a DBP less than 95 mm Hg two to four weeks after drug.