Renin Profiling in Selection of Initial Antihypertensive Drug
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this research study is to determine whether a simple blood test measuring a
      hormone called renin can better determine which first drug would be most effective in
      controlling blood pressure, in comparison with the more traditional approach recommended by
      JNC7 (Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High
      Blood Pressure).
    

Detailed description: 
      Hypothesis: That antihypertensive drug selection guided by activity of the renin angiotensin
      system will be superior to the strategy advocated in JNC 7 in achieving blood pressure
      control on monotherapy.

      Background: the National Heart, Lung, and Blood Institute, through the Joint National
      Committee on the Detection, Treatment and Control of Hypertension (JNC 7) has recommended
      that most hypertensive patients begin therapy with a diuretic and sequentially add other
      classes of drugs until blood pressure is controlled. This approach appears to assume
      homogeneity in the mechanism by which BP is controlled in different patients. When this
      standardized strategy has been rigidly applied in Clinical Trials, a majority of patients
      generally require 2 or more agents to achieve blood pressure control.

      The pioneering work of Laragh, Sealey and their colleagues, widely confirmed by others,
      suggests instead that heterogeneity, in fact, characterizes patterns of blood pressure
      control in populations. This heterogeneity can be exposed through assessment of the activity
      of the renin angiotensin system (RAS). Specifically, volume and vasoconstriction determine
      blood pressure control. Patients in whom volume predominates have suppressed RAS, and,
      conversely, those in whom vasoconstriction predominates will have an activated RAS. This can
      be simply and accurately determined by estimation of plasma renin activity (PRA).

      It has been demonstrated that volume and vasoconstriction dependent hypertensive patients
      respond best to different drugs. By exploitation of the RAS it is possible to provide
      rational therapy to each patients according to the mechanism by which blood pressure is
      controlled. The result is that appropriate therapy can be both more effective and more
      efficient. A specific system the Laragh Method has been designed to translate this
      physiologically based paradigm into a practical scheme or patient management.

      The purpose of this trial is to determine whether the Laragh Method will lead to better and
      more efficient blood pressure control in a general population of hypertensive patients than
      does the existing treatment strategy. The measure by which this hypothesis will be tested is
      percentage of hypertensive patients achieving blood pressure control on monotherapy.

      The significance of this trial is enormous for both individuals and society. Some 50 million
      Americans have hypertension and more than 25 million are currently in treatment. If the
      Laragh Method leads to more parsimonious and effective care, it will mean literally millions
      of individual patients will be spared the burden of unnecessary polypharmacy. Moreover, the
      strain on health care costs associated with antihypertensive therapy will be redu
    

Intervention name(s): olmesartan, hydrochlorothiazide, amlodipine; hydrochlorothiazide (HCTZ) or olmesartan
Intervention type(s): Drug; Drug
Intervention description(s): hydrochlorothiazide (HCTZ) 25mg OD, increased to 50 mg OD at 3 weeks. Olmesartan 20 mg OD, to be increased to 40 mg at 3 weeks. Amlodipine 5 mg, may be added at 6 weeks, if BP >140 mmHg; HCTZ 25 mg, increasing to 50 mg at 3-4 weeks or Olmesartan 20 mg, increasing to 40 mg at 3-4 weeks. If blood pressure >140/90 mmHg at 6 weeks, amlodipine 5 mg may be added
Other intervention name(s): Renin guided selection of treatment; Standard Therapy
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment