AzTrials
AzTrials

Cardiovascular DiseasesPhase 2NCT00000522

Treatment of Mild Hypertension Study (TOMHS)

A Phase 2 study testing diet, sodium-restricted, diet, reducing and exercise in people with Cardiovascular Diseases and Heart Diseases, run by University of Minnesota.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 69 years
What is being tested?
diet, sodium-restricted, diet, reducing and exercise
How many people
Not given
Where
No sites listed yet
Study dates
Aug 1985to May 1994
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

About this study

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.

Read the 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.

Being tested
diet, sodium-restricted, diet, reducing, exercise, alcohol restriction, chlorthalidone
Medical subject headings
Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • diet, sodium-restrictedBehavioural

  • diet, reducingBehavioural

  • exerciseBehavioural

  • alcohol restrictionBehavioural

  • chlorthalidoneDrug

  • acebutololDrug

  • doxazosinDrug

  • amlodipineDrug

  • enalaprilDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 1999 (estimated)
  2. Study startAug 1985
  3. Study completionMay 1994

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000522
Sponsor's protocol ID
41
Other IDs
R01HL034767
Status last verified
Feb 2016
First submitted
27 Oct 1999
Last updated
25 Feb 2016
Results posted
No

Publications

  • Mascioli SR, Grimm RH Jr, Neaton JD, Stamler J, Prineas RJ, Cutler JA, Elmer PJ, McDonald R, Schnaper H, Schoenberger J. Characteristics of participants at baseline in the Treatment of Mild Hypertension Study (TOMHS). Am J Cardiol. 1990 Sep 25;66(9):32C-35C. doi: 10.1016/0002-9149(90)90760-x.

    PubMed 2220647

  • The treatment of mild hypertension study. A randomized, placebo-controlled trial of a nutritional-hygienic regimen along with various drug monotherapies. The Treatment of Mild Hypertension Research Group. Arch Intern Med. 1991 Jul;151(7):1413-23. doi: 10.1001/archinte.151.7.1413.

    PubMed 2064494

  • Liebson PR, Grandits G, Prineas R, Dianzumba S, Flack JM, Cutler JA, Grimm R, Stamler J. Echocardiographic correlates of left ventricular structure among 844 mildly hypertensive men and women in the Treatment of Mild Hypertension Study (TOMHS). Circulation. 1993 Feb;87(2):476-86. doi: 10.1161/01.cir.87.2.476.

    PubMed 8425295

  • Neaton JD, Grimm RH Jr, Prineas RJ, Stamler J, Grandits GA, Elmer PJ, Cutler JA, Flack JM, Schoenberger JA, McDonald R, et al. Treatment of Mild Hypertension Study. Final results. Treatment of Mild Hypertension Study Research Group. JAMA. 1993 Aug 11;270(6):713-24.

    PubMed 8336373

  • Black HR. Treatment of mild hypertension. The more things change.. JAMA. 1993 Aug 11;270(6):757-9. No abstract available.

    PubMed 8336380

  • Flack JM, Neaton JD, Daniels B, Esunge P. Ethnicity and renal disease: lessons from the Multiple Risk Factor Intervention Trial and the Treatment of Mild Hypertension Study. Am J Kidney Dis. 1993 Apr;21(4 Suppl 1):31-40. doi: 10.1016/s0272-6386(12)80859-6.

    PubMed 8465834

  • Elmer PJ, Grimm R Jr, Laing B, Grandits G, Svendsen K, Van Heel N, Betz E, Raines J, Link M, Stamler J, et al. Lifestyle intervention: results of the Treatment of Mild Hypertension Study (TOMHS). Prev Med. 1995 Jul;24(4):378-88. doi: 10.1006/pmed.1995.1062.

    PubMed 7479629

  • Stamler J, Prineas RJ, Neaton JD, Grimm RH, McDonald RH, Schnaper HW, Schoenberger JA, Elmer PJ, Cutler JA. Background and design of the new U.S. trial on diet and drug treatment of "mild" hypertension (TOMHS). Am J Cardiol. 1987 May 29;59(14):51G-60G. doi: 10.1016/0002-9149(87)90158-5.

    PubMed 3296721

  • 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.

  • Grandits GA, Liebson PR, Dianzumba S, Prineas RJ. Echocardiography in multicenter clinical trials: experience from the Treatment of Mild Hypertension Study. Control Clin Trials. 1994 Oct;15(5):395-410. doi: 10.1016/0197-2456(94)90035-3.

    PubMed 8001359

  • Liebson PR, Grandits GA, Dianzumba S, Prineas RJ, Grimm RH Jr, Neaton JD, Stamler J. Comparison of five antihypertensive monotherapies and placebo for change in left ventricular mass in patients receiving nutritional-hygienic therapy in the Treatment of Mild Hypertension Study (TOMHS). Circulation. 1995 Feb 1;91(3):698-706. doi: 10.1161/01.cir.91.3.698.

    PubMed 7828296

  • Crow RS, Prineas RJ, Rautaharju P, Hannan P, Liebson PR. Relation between electrocardiography and echocardiography for left ventricular mass in mild systemic hypertension (results from Treatment of Mild Hypertension Study). Am J Cardiol. 1995 Jun 15;75(17):1233-8.

    PubMed 7778546

  • Grimm RH Jr, Flack JM, Grandits GA, Elmer PJ, Neaton JD, Cutler JA, Lewis C, McDonald R, Schoenberger J, Stamler J. Long-term effects on plasma lipids of diet and drugs to treat hypertension. Treatment of Mild Hypertension Study (TOMHS) Research Group. JAMA. 1996 May 22-29;275(20):1549-56. doi: 10.1001/jama.1996.03530440029033.

    PubMed 8622245

  • Grimm RH Jr, Grandits GA, Prineas RJ, McDonald RH, Lewis CE, Flack JM, Yunis C, Svendsen K, Liebson PR, Elmer PJ. Long-term effects on sexual function of five antihypertensive drugs and nutritional hygienic treatment in hypertensive men and women. Treatment of Mild Hypertension Study (TOMHS). Hypertension. 1997 Jan;29(1 Pt 1):8-14. doi: 10.1161/01.hyp.29.1.8.

    PubMed 9039073

  • Lewis CE, Grandits A, Flack J, McDonald R, Elmer PJ. Efficacy and tolerance of antihypertensive treatment in men and women with stage 1 diastolic hypertension. Results of the Treatment of Mild Hypertension Study. Arch Intern Med. 1996 Feb 26;156(4):377-85.

    PubMed 8607723

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing diet, sodium-restricted, diet, reducing and exercise in people with Cardiovascular Diseases and Heart Diseases, run by University of Minnesota.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000522, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.

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