Refractory HypertensionPhase 2NCT03223272
Mechanisms of Refractory Hypertension (Reserpine)
A Phase 2 study testing Reserpine in people with Refractory Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Refractory Hypertension
- What is being tested?
- Reserpine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2015to 31 Jan 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult with refractory hypertension defined as uncontrolled office blood pressure with use of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone
Who cannot join
- 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
Show all 9Show fewer
- 2nd or 3rd degree heart block
- known intolerance of reserpine
- use of digoxin or tricycle antidepressants
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Reserpine
- Keywords
- hypertension, sympathetic tone, resperpine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReserpineDrug
Open label reserpine 0.1 mg pill orally
| Study group | Role | What they receive |
|---|---|---|
| Reserpine | Experimental | Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks. Receives: Drug: Reserpine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Ambulatory Systolic Blood Pressure
Twenty-four hour ambulatory systolic blood pressure
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start23 Jul 2015
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractory HypertensionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, dose titration study
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Calhoun, University of Alabama at Birmingham
- Investigators
- David A Calhoun, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223272
- Sponsor's protocol ID
- 130822008
- Status last verified
- Nov 2021
- First submitted
- 17 Jul 2017
- Last updated
- 30 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: One year after study completion, de-identified subject demographic data and primary outcome data will be available by request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Refractory Hypertension (Reserpine)
- ClinicalTrials.gov ID
- NCT03223272
- Acronym / sponsor ID
- 130822008
- Conditions
- Refractory Hypertension
- Keywords
- hypertension, sympathetic tone, resperpine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 23 Jul 2015 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 30 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, dose titration study
| Arm | Type | Receives |
|---|---|---|
| Reserpine | Experimental | Drug: ReserpineSubjects will receive open-label reserpine 0.1 mg daily for 4 weeks. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult with refractory hypertension defined as uncontrolled office blood pressure with use of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReserpineOpen label reserpine 0.1 mg pill orally | Drug | Reserpine |
Primary outcome
Change Ambulatory Systolic Blood Pressure
Time frame: Baseline and 8 weeks
Twenty-four hour ambulatory systolic blood pressure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. One year after study completion, de-identified subject demographic data and primary outcome data will be available by request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Calhoun, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reserpine in people with Refractory Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Ambulatory Systolic Blood Pressure (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.