N-of-1 Trials for Blood Pressure Medications in Adults
Condition: Hypertension; High Blood Pressure
MeSH terms: Hypertension
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Many patients want to know which blood pressure medication is the best for them. In this
      study, we will test the feasibility of a new approach to determining the best blood pressure
      medication for individual patients by performing an N-of-1 trial in which patients will have
      the opportunity to test a series of 3 blood pressure medications at escalating doses while
      carefully measuring their blood pressure and side-effects. At the end of each of these N-of-1
      trials, we will ask patients to complete a questionnaire in which they rate their level of
      satisfaction with this approach to learning about which is the best blood pressure medication
      for them.
    

Detailed description: 
      The goal of this research is to empower hypertensive patients to learn which blood pressure
      (BP) medication is best for them. Although lifestyle factors such as diet and exercise play
      an important role, medications may still needed to achieve BP control. Yet, there are
      substantial differences in the way BP medications affect patients; medications well-tolerated
      in some, cause severe side-effects in others. Similarly, medications that cause larger
      reductions in BP in some patients have smaller BP lowering effects in others. Despite this
      heterogeneity in treatment effects, there are no proven real-world methods to help patients
      identify the medication most suited to their needs.

      One potential approach to individualizing BP treatment decisions is to conduct N-of-1 trials:
      a multiple crossover design conducted in a single patient. Despite the appeal of this
      approach, there are few published reports of BP medication N-of-1 trials. Therefore, the
      objective of this study is to determine the feasibility of conducting an N-of-1 BP medication
      trial in hypertensive patients. Patients who meet all the eligibility criteria will be asked
      to monitor their blood pressure and side-effects while taking a series of commonly prescribed
      blood pressure medications. If they are already taking a blood pressure medication, they will
      begin by tracking their blood pressure and side-effects while taking this medication for 1
      week. They will then be asked to track their blood pressure and side-effects while taking a
      series of up to three other blood pressure medications (losartan - a renin-angiotensin system
      blocking agent, amlodipine - a calcium channel blocker, and hydrochlorothiazide - a thiazide
      diuretic). Each of these medications will be taken for 2 weeks at a time. The specific choice
      of medications and medication doses will be selected by the study physician. Unless patients
      have side-effects that lead them to discontinue a medication early, patients will be expected
      to take each medication at least twice in a balanced sequence (e.g., losartan - amlodipine -
      HCTZ - HCTZ - amlodipine - losartan). Patients will measure their blood pressure and
      medication side-effects during the 2nd week on each of these medications. Patients will have
      the option of escalating or decreasing dosages to identify the single medication/medication
      dose that best lowers their blood pressure with the least side-effects. Blood pressure will
      be measured using an Omron home blood pressure monitor. Side-effects will be tracked using a
      daily e-mailed survey that is completed over the Internet.
    

Intervention name(s): Losartan; Amlodipine; Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): An angiotensin II receptor antagonist drug used mainly to treat high blood pressure.; A calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of hypertension.; A diuretic medication often used to treat high blood pressure and swelling due to fluid build up.
Other intervention name(s): Losartan potassium tablets; Cozaar; Amlodipine besylate tablets; Norvasc; HCTZ; Hydrochlorothiazide tablets
Intervention MeSH terms: Losartan; Amlodipine; Hydrochlorothiazide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hydrochlorothiazide tablet; Norvasc; Cozaar; amlodipine besylate tablets; losartan potassium tablets; Hypertension; High Blood Pressure