Mechanisms of Refractory Hypertension (Reserpine)

Refractory Hypertension Clinical Trial

Official title:

Mechanisms of Refractory Hypertension (Reserpine)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223272
• Other study ID #: 130822008
• Status: Completed
• Phase: Phase 2
• Start date: July 23, 2015
• Est. completion date: January 31, 2020

Study information

• Verified date: November 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult with refractory hypertension defined as uncontrolled office blood pressure with use of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone

Exclusion Criteria:

• congestive heart failure (EF 40%)

• chronic kidney disease (GFR <40 ml/min/1.73 mm)

• stroke and/or myocardial infarction or acute CHF exacerbation within last 3 months

• ongoing depression

• active peptic ulcer disease

• bradycardia <50 beats per minute

• 2nd or 3rd degree heart block

• known intolerance of reserpine

• use of digoxin or tricycle antidepressants

Related Conditions & MeSH terms

• Hypertension
• Refractory Hypertension

Intervention

Drug:
• Reserpine
Open label reserpine 0.1 mg pill orally

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Ambulatory Systolic Blood Pressure	Twenty-four hour ambulatory systolic blood pressure	Baseline and 8 weeks