NCT01650402

Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to \<130 mmHg (intensive control) versus \<145 mmHg (standard control) slows/halts the progression of deterioration of mobility and cognitive function linked to white-matter disease (also known as white-matter hyperintensity or WMH) in patients with normal or mildly impaired mobility and cognition in subjects with detectable cerebrovascular disease (\>0.5% WMH fraction of intracranial contents). The study patients will be enrolled and randomized to one of two levels of ambulatory blood pressure control (intensive to achieve a goal 24-hour systolic blood pressure of \< 130 mmHg or standard to achieve a goal 24-hour systolic blood pressure of \< 145 mmHg) for a total of 36 months.

Detailed description

The study patients will be enrolled and randomized to one of two levels of ambulatory BP control (intensive to achieve a goal 24-hour systolic BP of \< 130 mmHg or standard to achieve a goal 24-hour systolic BP of \< 145 mmHg) for a total of 36 months. Similar antihypertensive regimens will be used in both of the treatment groups. Titration of antihypertensive therapies will be performed at monthly intervals for the first 3 to 6 months post-randomization to achieve goal systolic BP. The primary and secondary outcomes will be evaluated at baseline, and following 18 months and 36 months of therapy.

Conditions

• Hypertension, Systolic
• Cerebrovascular Disease

Interventions

Type	Name	Description
OTHER	Anti-hypertensive therapy to SBP 130 mm Hg	Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg
OTHER	Anti-hypertensive therapy to SBP 145 mm Hg	Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg

Timeline

• Start date: 2011-12-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2012-07-26
• Last updated: 2020-11-18
• Results posted: 2020-10-30

Locations

1 site across 1 country: United States