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Treatment of Mild Hypertension Study (TOMHS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000522
First Posted: October 28, 1999
Last Update Posted: February 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Study Start Date: August 1985
Estimated Study Completion Date: May 1994
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000522


Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Richard Grimm University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Prineas RJ, Grimm R, Grandits G, et al: The Effect of Dietary Sodium and Body Weight on Echocardiographic Measures of Left Ventricular Mass Among Treated Hypertensive Men and Women: Four-Year Change in the TOMHS Study. Nieren-und Hochdruck-krankheiten, Jahrgang 23:S14-S21, 1994.

ClinicalTrials.gov Identifier: NCT00000522     History of Changes
Other Study ID Numbers: 41
R01HL034767 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: February 25, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Amlodipine
Enalapril
Chlorthalidone
Doxazosin
Acebutolol
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Anti-Arrhythmia Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents