Phase 2
N=7
Mechanisms of Refractory Hypertension (Reserpine)
Refractory Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03223272 ↗Enrolled (actual)
7
Serious AEs
14.3%
Results posted
Nov 2021
Primary outcome: Primary: Change Ambulatory Systolic Blood Pressure — -29.3 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Reserpine (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change Ambulatory Systolic Blood Pressure |
-29.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03223272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.