ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients with Resistant Hypertensio

Phase 3

Completed

• Conditions: High Blood Pressure; Hypertension; 10057166

• Registration Number: NL-OMON39868
• Lead Sponsor: Clinical Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Office Systolic blood pressure >= 140 mmHg based on an average of 3 blood pressure readings;2. Ambulatory Blood Pressure Monitoring (ABPM) daytime average:
• Systolic blood pressure (SBP) >= 135 mmHg;
AND
• Diastolic blood pressure (DBP) >= 85 mmHg ;See Protocol Section 4.4.1 for complete Inclusion Criteria

Exclusion Criteria

1. Secondary hypertension attributable to a cause other than sleep apnea
2. Type I diabetes
See Protocol Section 4.4.2 for complete Exclusion Criteria

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoints:<br /><br>- Change in 24-hour ABPM mean systolic blood pressure (SBP) at six<br /><br>months as compared to baseline<br /><br>- Change in mean office SBP at six months as compared to baseline</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints:<br /><br>- Change in 24-hour ABPM mean diastolic blood pressure (DBP) at six<br /><br>months as compared to baseline<br /><br>- Change in mean office DBP at six months as compared to baseline<br /><br>- Change in mean home SBP and DBP at six months as compared to baseline<br /><br>- Incidence of complications directly associated with delivery and/or<br /><br>use of the ROX Coupler</p><br>