Treatment of Mild Hypertension Study (TOMHS)

NCT00000522 | Completed Phase 2

• 2 other identifiers: 41R01HL034767
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Interventions

diet, sodium-restricted BEHAVIORAL

diet, reducing BEHAVIORAL

exercise BEHAVIORAL

alcohol restriction BEHAVIORAL

chlorthalidone DRUG

acebutolol DRUG

doxazosin DRUG

amlodipine DRUG

enalapril DRUG

Eligibility Criteria

• Age: 45 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Minnesota: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Publications (19)

• 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.

  PMID: 2220647 BACKGROUND

• 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.

  PMID: 2064494 BACKGROUND

• 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.

  PMID: 8425295 BACKGROUND

• 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.

  PMID: 8336373 BACKGROUND

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

  PMID: 8336380 BACKGROUND

• 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.

  PMID: 8465834 BACKGROUND

• 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.

  PMID: 7479629 BACKGROUND

• 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.

  PMID: 3296721 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 8001359 BACKGROUND

• 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.

  PMID: 7828296 BACKGROUND

• 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.

  PMID: 7778546 BACKGROUND

• 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.

  PMID: 8622245 BACKGROUND

• 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.

  PMID: 9039073 BACKGROUND

• 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.

  PMID: 8607723 BACKGROUND

• Grimm RH Jr, Grandits GA, Cutler JA, Stewart AL, McDonald RH, Svendsen K, Prineas RJ, Liebson PR. Relationships of quality-of-life measures to long-term lifestyle and drug treatment in the Treatment of Mild Hypertension Study. Arch Intern Med. 1997 Mar 24;157(6):638-48.

  PMID: 9080918 BACKGROUND

• Ganguli MC, Grimm RH Jr, Svendsen KH, Flack JM, Grandits GA, Elmer PJ. Urinary sodium and potassium profile of blacks and whites in relation to education in two different geographic urban areas. TOMHS Research Group. Treatment of Mild Hypertension Study. Am J Hypertens. 1999 Jan;12(1 Pt 1):69-72. doi: 10.1016/s0895-7061(98)00218-0.

  PMID: 10075387 BACKGROUND

• Ganguli MC, Grimm RH Jr, Svendsen KH, Flack JM, Grandits GA, Elmer PJ. Higher education and income are related to a better Na:K ratio in blacks: baseline results of the Treatment of Mild Hypertension Study (TOMHS) data. Am J Hypertens. 1997 Sep;10(9 Pt 1):979-84. doi: 10.1016/s0895-7061(97)00162-3.

  PMID: 9324102 BACKGROUND

• Grandits GA, Grimm RH Jr, Prineas RJ, Grambsch P, Holland LA. Obtaining event status at the close of the Treatment of Mild Hypertension Study: methods and implication for other trials. Control Clin Trials. 2001 Feb;22(1):56-61. doi: 10.1016/s0197-2456(00)00121-5.

  PMID: 11165424 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Interventions

Diet, Sodium-Restricted; Diet, Reducing; Exercise; Ethanol; Chlorthalidone; Acebutolol; Doxazosin; Amlodipine; Enalapril

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Alcohols; Organic Chemicals; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Propanols; Amines; Prazosin; Quinazolines; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Richard Grimm

  University of Minnesota

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: August 1, 1985
• Study Completion: May 1, 1994
• Last Updated: February 25, 2016

Record last verified: 2016-02