Clinical Trial: Treatment of Masked Hypertension

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Treatment of Masked Hypertension

Brief 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 cl

Detailed Summary:
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome: Percentage of participants with masked hypertension [ Time Frame: 4 months ]

Percentage of participants with masked hypertension defined as a 24hr ambulatory systolic blood pressure >130 mmHg and a clinic systolic blood pressure <140 mmHg


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in urine albumin to creatinine ratio at 4 months [ Time Frame: Baseline, 4 months ]
  • Change from baseline in pulse wave velocity at 4 months [ Time Frame: Baseline, 4 months ]
  • Change from baseline in 24hr ambulatory systolic blood pressure at 4 months [ Time Frame: Baseline, 4 months ]


Original Secondary Outcome: Same as current

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: May 16, 2014
Date Started: June 2014
Date Completion: March 2019
Last Updated: June 15, 2016
Last Verified: June 2016