Refractory Hypertension
Conditions
Keywords
hypertension, sympathetic tone, resperpine
Brief 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.
Interventions
DRUGReserpine
Open label reserpine 0.1 mg pill orally
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, dose titration study
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Ambulatory Systolic Blood Pressure | Baseline and 8 weeks | Twenty-four hour ambulatory systolic blood pressure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reserpine Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks.
Reserpine: Open label reserpine 0.1 mg pill orally | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Reserpine |
|---|---|
| Age, Continuous | 49.5 years STANDARD_DEVIATION 9.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 1 / 7 |
Outcome results
Primary
Change Ambulatory Systolic Blood Pressure
Twenty-four hour ambulatory systolic blood pressure
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reserpine | Change Ambulatory Systolic Blood Pressure | -29.3 mmHg | Standard Deviation 22.2 |