Treatment of Masked Hypertension

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02142881
Study type	Interventional
Source	University of Minnesota - Clinical and Translational Science Institute
Contact
Status	Completed
Phase	Phase 3
Start date	June 2014
Completion date	December 7, 2017

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04591808` - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia	Phase 3
Recruiting	`NCT04515303` - Digital Intervention Participation in DASH
Completed	`NCT05433233` - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension	N/A
Completed	`NCT05491642` - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses	Phase 1
Completed	`NCT03093532` - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT05529147` - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting	`NCT06363097` - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Recruiting	`NCT05976230` - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Completed	`NCT06008015` - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers	Phase 1
Completed	`NCT05387174` - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period	N/A
Completed	`NCT04082585` - Total Health Improvement Program Research Project
Recruiting	`NCT05121337` - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension	N/A
Withdrawn	`NCT04922424` - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men	Phase 1
Active, not recruiting	`NCT05062161` - Sleep Duration and Blood Pressure During Sleep	N/A
Not yet recruiting	`NCT05038774` - Educational Intervention for Hypertension Management	N/A
Completed	`NCT05087290` - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed	`NCT05621694` - Exploring Oxytocin Response to Meditative Movement	N/A
Completed	`NCT05688917` - Green Coffee Effect on Metabolic Syndrome	N/A
Recruiting	`NCT05575453` - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure	N/A