NCT03223272

Mechanisms of Refractory Hypertension (Reserpine)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study is deigned to determine if refractory hypertension is attributable to heightened sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic agent, in patients failing other classes of antihypertensive agents.

Detailed description

Patients with refractory hypertension, defined as uncontrolled office blood pressure despite use of 5 or more antihypertensive agents, including a thiazide diuretic and spironolactone. After withdrawal from other centrally-acting agents if needed, enrolled patients will be randomized to open-label reserpine 0.1 mg daily for 4 weeks. Twenty-four hour ambulatory blood pressure monitoring will be done at baseline, after the initial 4-week treatment period. All other antihypertensive medications will remain unchanged during the 4-week treatment period. The primary endpoint will be change in 24-hr ambulatory systolic blood pressure.

Conditions

• Refractory Hypertension

Interventions

Type	Name	Description
DRUG	Reserpine	Open label reserpine 0.1 mg pill orally

Timeline

• Start date: 2015-07-23
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2017-07-21
• Last updated: 2021-11-30
• Results posted: 2021-11-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study