Treatment of Masked Hypertension
Condition: Masked Hypertension; Hypertension; Chronic Renal Insufficiency
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Hypertension; Masked Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To date, most observational and all intervention studies have defined hypertension on the
      basis of clinic blood pressure (BP). Measurement of BP outside the clinic with home or
      ambulatory BP provides a better estimate of the risk of cardiovascular disease and all-cause
      mortality. Using clinic and ambulatory BPs, patients can be categorized as normotensive
      (normal clinic and ambulatory BPs), white-coat hypertension (elevated clinic BP with normal
      ambulatory BP), masked hypertension (normal clinic BP with elevated ambulatory BP), and
      sustained hypertension (elevated clinic and ambulatory BP). Approximately one third of
      patients with chronic kidney disease (CKD) with normal clinic BP have elevated ambulatory BP
      (masked hypertension). We demonstrated that, among participants from the Chronic Renal
      Insufficiency Cohort (CRIC) study, low estimated glomerular filtration rate (eGFR) and
      elevated proteinuria are associated with increased odds of masked hypertension. Additionally,
      participants with masked hypertension had increased risk for target organ damage as assessed
      by left ventricular mass and pulse wave velocity. These results in participants with CKD are
      consistent with prior studies in patients with normal renal function that demonstrated a
      two-fold increased risk for cardiovascular events in patients with masked hypertension
      compared to patients with normal clinic and ambulatory BP. Despite this elevated risk for
      adverse outcomes, patients with masked hypertension have been excluded from hypertension
      trials because of their normal clinic BP. Therefore, it is unknown whether the reduction in
      target organ damage and adverse cardiovascular outcomes associated with treatment of
      hypertension extends to patients with masked hypertension. To address this important gap in
      knowledge, we are planning a randomized, controlled trial to evaluate whether
      antihypertensive treatment can modify BP patterns in patients with masked hypertension, that
      is, convert them to controlled clinic and ambulatory BP. We will also evaluate the effect
      antihypertensive treatment on target organ damage in patients with masked hypertension. The
      current study is a pilot randomized controlled trial to evaluate the feasibility of the
      planned trial and the effect of antihypertensive therapy on clinic and ambulatory BP,
      proteinuria, and target organ damage in patients with masked hypertension.
    


Intervention name(s): Antihypertensive medication intensification; Usual care
Intervention type(s): Other; Other
Intervention description(s): Antihypertensive medications will be adjusted by study staff based on ambulatory and clinic BP results at baseline and 2 months with a target 24hr systolic blood pressure of <130 mmHg.; Antihypertensive medications will be adjusted by the participants' providers (usual care).
Intervention MeSH terms: Antihypertensive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment