Trial of Antihypertensive Intervention Management
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the Trial of Antihypertensive Intervention Management (TAIM) was to
      determine the efficacy of dietary management and/or drug therapy, namely thiazide-like
      diuretics or a beta-blocker, in the control of mild hypertension. Additionally, the
      Continuation of the Trial of Antihypertensive Intervention Management (COTAIM) tested the
      effects of long-term weight reduction, and sodium/potassium changes added to weight
      reduction, as well as the original drug treatment, on the failure rate of blood pressure
      control.
    

Detailed description: 
      BACKGROUND:

      The Trial of Antihypertensive Intervention Management was an extension of the NHLBI-supported
      Dietary Intervention Study of Hypertension (DISH) which concluded in March 1984 and showed
      that either weight reduction or sodium restriction diets reduced relapse rates of
      hypertensives who had received long-term drug treatment and then been withdrawn from drugs.
      TAIM was initiated in April 1984 and continued for four years at three centers and added to
      DISH the art of evaluating combined drug and dietary treatments. COTAIM was continued at
      three clinical sites in July 1988. Analysis of COTAIM results continued through November 1994
      under grant R01HL40072.

      DESIGN NARRATIVE:

      TAIM patients were randomly assigned to one of three diets and to one of three drug regimens.
      The dietary interventions consisted of a weight loss program, sodium reduction with increased
      potassium intake, or no change in diet. The drug regimen consisted of a beta-blocker
      (atenolol), a thiazide-like diuretic (chlorthalidone), or placebo. The major endpoint was
      change in diastolic blood pressure after six months of intervention. Individuals who did not
      reach goal blood pressure after six months received additional drugs. Other endpoints
      included total risk factor score change, psychological function, and lifestyle change.

      COTAIM consisted of two studies with a total of 600 subjects. COTAIM I compared the TAIM
      weight loss group to a randomly selected half of the usual diet group. The primary endpoint
      of COTAIM I was the degree of control of blood pressure on initial TAIM therapy between TAIM
      baseline and the end of COTAIM, a five year period.

      COTAIM II added a weight loss regimen both to the sodium restriction/potassium
      supplementation groups and to the other half of the usual diet group. The primary outcome was
      control of blood pressure on initial TAIM therapy between COTAIM baseline and the end of
      COTAIM, a two-year period.
    

Intervention name(s): diet, reducing; diet, sodium-restricted; chlorthalidone; atenolol
Intervention type(s): Behavioral; Behavioral; Drug; Drug
Intervention MeSH terms: Atenolol; Chlorthalidone
Allocation: Randomized
Primary purpose: Treatment