HypertensionBP MAPNCT03818659
Improving BP Control in Diverse Populations Using BP MAP
A study testing Self-Guided M.A.P. BP Improvement Program and Full Support M.A.P. BP Improvement Program in people with Hypertension, run by University of California, San Francisco at 24 sites in United States.
Trial summary
BP-MAP is a cluster randomized controlled trial (RCT) designed to compare the effectiveness of BP lowering from a clinic-based quality improvement program with Full Support (dedicated practice facilitation) vs. a Self-Guided version of the program. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Self-Guided M.A.P. BP Improvement Program and Full Support M.A.P. BP Improvement Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,238,835 participants
- Where
- 24 sitesUnited States
- Study dates
- 1 Jul 2019to 30 Jun 2021
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
ACTIVE CLINICS
For inclusion as an Active Clinic in this study, clinics may participate must be able to identify:
- A Site Champion who works at the clinic and who is willing to take primary responsibility for implementing the M.A.P. intervention
- A Physician Champion who works at the clinic and who is willing to advocate actively for the M.A.P. intervention
- A Practice Change Facilitator willing to attend a 1-day training and help guide implementation of the M.A.P intervention for Full Support sites, with the support of AMA staff (may be the Site Champion or Physician Champion, or a person with regional responsibilities who can support multiple sites)
Sites will be excluded if they:
- Have implemented any high blood pressure quality improvement component from the M.A.P. BP improvement program as part of Target: BP or from the AMA or Target: BP websites
- Are currently involved in an ongoing clinical trial or grant funded project related to high blood pressure or hypertension
USUAL CARE CLINICS:
Usual Care Clinics will include PCORnet Datamarts participating in BP TRACK, a concurrently-running BP Control Registry within PCORnet that will provide quarterly datamart-level estimates of BP control and other aggregate metrics relevant to BP control. All participating datamarts will be included, with the following exceptions:
- Datamarts with any Active Clinics participating in BP MAP will be excluded
- Datamarts that obscure dates via date-shifting will be excluded, as this will not allow for control of concurrent secular trends
PATIENTS
Within clinics (Active or Usual Care), patients will be eligible (and identified from the electronic health record) if they meet National Quality Forum BP Control Metric (NQF 0018) criteria:
- Age 18-85 on the date of analysis
- At least one outpatient encounter with a diagnosis of hypertension during the first six months of the measurement year (ending on the date of analysis)
- No diagnosis or evidence of end-stage renal disease on or prior to the end of the measurement year
- No pregnancy during the measurement year
- No admission to an inpatient setting during the measurement year
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Belle Chasse Community Health Center
Belle Chasse, Louisiana, 70037
Public Health: Seattle & King County Eastgate Public Health Center
Bellevue, Washington, 98007
Public Health: Seattle & King County Primary Care at Navos
Burien, Washington, 98166
Daughters of Charity Carrollton
Carrollton, Louisiana, 70118
St. Bernard Community Health Center
Chalmette, Louisiana, 70043
Open Door Del Norte CHC
Crescent City, California, 95531
Open Door Eureka Community Health & Wellness Center
Eureka, California, 95501
Daughters of Charity Gretna
Gretna, Louisiana, 70056
Daughters of Charity Kenner
Kenner, Louisiana, 70065
Kenner Community Health Center
Kenner, Louisiana, 70065
Cowlitz County Health Department Cowlitz County: North Beach Clinic
Longview, Washington, 98632
QueensCare Echo Park Clinic
Los Angeles, California, 90026
St Charles Community Health Center- Paul Maillard
Luling, Louisiana, 70070
St. Charles Community Health Center
Luling, Louisiana, 70070
Daughters of Charity Metairie
Metairie, Louisiana, 70001
Daughters of Charity St. Cecilia
New Orleans, Louisiana, 700117
Daughters of Charity Higgins
New Orleans, Louisiana, 700126
Daughters of Charity New Orleans East
New Orleans, Louisiana, 700127
Access Health Louisiana Primary Care at the Pythian
New Orleans, Louisiana, 70112
Daughters of Charity Gentilly
New Orleans, Louisiana, 70122
Waterfall CHC
North Bend, Oregon, 97459
Monterey County Health Department Laurel Family Practice
Salinas, California, 93906
Public Health: Seattle & King County Downtown Public Health Center
Seattle, Washington, 98121
Tillamook CHC
Tillamook, Oregon, 97141
About this study
Official title: Improving Blood Pressure Control in Diverse Populations by Measuring Accurately, Acting Rapidly, and Partnering With Patients
BP-MAP is a cluster randomized controlled trial (RCT) designed to compare the effectiveness of BP lowering from a clinic-based quality improvement program with Full Support (dedicated practice facilitation) vs. a Self-Guided version of the program. The American Medical Association (AMA) developed the framework for the interventions.
Read the detailed description
BP-MAP is a cluster randomized controlled trial (RCT) designed to compare the effectiveness of BP lowering from a clinic-based quality improvement program with Full Support (dedicated practice facilitation) vs. a Self-Guided version of the program. The American Medical Association (AMA) developed the framework for the interventions. The trial will be conducted within the National Patient-Centered Clinical Research Network (PCORnet) that enables distributed querying of electronic health record data in a common data model. The primary outcome will be change in clinic-level blood pressure (BP) control at 6 months. Secondary outcomes will include other blood pressure (BP) control metrics, other time points (12 and 18 months), and process measures such as BP measurement accuracy, medication intensification, and average systolic blood pressure (SBP) reduction after a medication intensification, and repeat visit within 4 weeks after a visit with elevated BP. The investigators hypothesize clinics randomized to the Full Support version will achieve a larger increase from baseline in the proportion of their hypertensive patients with controlled BP at 6 months as compared to clinics randomized to the Self-Guided version, and also as compared with usual care. The investigators will also conduct non-randomized comparisons of BP control in the Full Support and Self-Guided intervention arms to BP control in non-participating "Usual Care" institutions in PCORnet. This study was submitted to the IRB at UCSF, determined to be quality improvement and exempt from further review.
- Conditions
- Hypertension
- Being tested
- Self-Guided M.A.P. BP Improvement Program, Full Support M.A.P. BP Improvement Program
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Guided M.A.P. BP Improvement ProgramOther
Active Clinics randomized to the Self-Guided Arm will receive access to an AHA/AMA web platform that includes the posted M.A.P. materials and limited access to AMA Staff who are available to answer questions. The study team will facilitate access to staff by hosting a kick-off webinar for program participants that will include an orientation to the materials on the website, general advice and practical tips about what works for implementation, and time for answering questions and discussion with the group.
Full Support M.A.P. BP Improvement ProgramOther
Active Clinics randomized to the Full Support Arm will receive online access to M.A.P. materials and orientation webinar and also a Practice Change Facilitator who will lead the health center clinical staff, site champions and physician leads at each clinic over the course of 6 months to support the implementation of the MAP Program. With support from an AMA "Improvement Advisor", the Practice Change Facilitators will perform a baseline assessment of current workflows and assess each domain of M.A.P. The goal of the Full Support program is to help care teams develop skills and sustainable workflows that are effective at attaining and maintaining high levels of BP control.
| Study group | Role | What they receive |
|---|---|---|
| Self-Guided | Active comparator | Active Clinics randomized to the Self-Guided Arm will receive access to an AHA/AMA web platform that includes the posted M.A.P. materials and limited access to AMA Staff who are available to answer questions. The study team will facilitate access to staff by hosting a kick-off webinar for program participants that will include an orientation to the materials on the website, general advice and practical tips about what works for implementation, and time for answering questions and discussion with the group. Receives: Other: Self-Guided M.A.P. BP Improvement Program |
| Full Support | Experimental | Active Clinics randomized to the Full Support Arm will receive online access to M.A.P. materials and orientation webinar and also a Practice Change Facilitator who will lead the health center clinical staff, site champions and physician leads at each clinic over the course of 6 months to support the implementation of the MAP Program. With support from an AMA "Improvement Advisor", the Practice Change Facilitators will perform a baseline assessment of current workflows and assess each domain of M.A.P. The goal of the Full Support program is to help care teams develop skills and sustainable workflows that are effective at attaining and maintaining high levels of BP control. Receives: Other: Full Support M.A.P. BP Improvement Program |
| Usual Care | No intervention | The investigators will also conduct non-randomized comparisons of BP control in the Full Support and Self-Guided intervention arms to BP control in non-participating "Usual Care" institutions in PCORnet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Pressure Control, % of Patients
The primary outcome will be clinic-level change in the proportion of patients with controlled BP from baseline to 6 months after the start of the intervention. BP control will be defined according to NQF 0018 as the percent of eligible patients (defined below) with SBP <140 mmHg and DBP < 90 mmHg, based on measurements obtained at the most recent ambulatory clinical encounter at baseline (using the lowest measures of SBP and DBP at that encounter) and similarly at the 6-month time point after initiation of the intervention.
Measured: baseline and 6 months
Secondary outcomes (9)
Change in Improvement in Blood Pressure, % of Patients
This overall measure of BP improvement implements CMS065v4[ref], which defines BP improvement as either a reduction of 10 mmHg in SBP or achievement of SBP that is "adequately controlled" (SBP < 140 mmHg) in months 12 of the measurement period, among hypertensive patients not previously controlled.
Measured: baseline and 12 months
Change in Confirmatory Repeated Blood Pressure Measurement, % of Visits
This process measure is designed to capture the practice of repeating a blood pressure measurement in the same visit when the first measurement done in clinic is high (SBP≥140 mmHg or DBP≥90 mmHg).
Measured: baseline and 6 months
Change in Medication Intensification, % of Visits
This process measure captures the proportion of visits where BP is uncontrolled where a medication is ordered that is of a different class of medication than had previously been used. Note that this explicitly does not give credit for ordering a simple refill or medication dose increase, or use of a different medication in the same class.
Measured: baseline and 6 months
Change in Average Systolic Blood Pressure (SBP) Reduction After a Medication Intensification Visit, mmHg
This continuous metric describes the change in SBP (+/- standard deviation) observed between a visit with a medication intensification to the subsequent visit occurring at least 10 days later.
Measured: baseline and 6 months
Change in Repeat Visit in 4 Weeks After a Visit With Elevated BP, % of Visits
This process measure captures the proportion of persons who had uncontrolled HTN who made a subsequent visit within the following 4 weeks.
Measured: baseline and 6 months
Change in Use of Fixed Dose Combination Product Among Patients Taking 2 or More Classes of Medications, % of Patients
Use of fixed dose combination medications helps with adherence, promotes rational combinations of medications, and increases likelihood of achieving BP control. This metric, which is limited to patients taking more than one medication class, describes the prevalence of fixed dose combination pill use.
Measured: baseline and 6 months
Change in Use of a CCB or Thiazide or Thiazide-like Diuretic Among African-American Patients on at Least One Medication, % of Patients
Use of calcium channel blockers (CCB) OR a thiazide or thiazide-like diuretic medication classes is recommended to treat black or African American patients as first line monotherapy due to increased efficacy. This metric, which is limited to African-American patients with a diagnosis of hypertension taking at least one medication class, describes the prevalence of those receiving the recommended drug class.
Measured: baseline and 6 months
Change in Terminal Digit = Zero, % of Measurements
Inappropriate rounding of blood pressure measurements (usually to zero) leads to measurement error and worse treatment decisions. This continuous metric is calculated for a clinic as the percent of measurements at that clinic (for hypertensive patients) where the terminal digit of the measurement is zero. A percent greater than 10% (if an automated BP monitor is used) or greater than 20% (if a manual BP monitor is used with recommended rounding to even digits) indicates evidence of inappropriate rounding. Unlike most of our metrics, lower is better, down to an ideal value of 10-20%, which would be expected if no rounding were occurring.
For this study we calculated the change in this continuous metric for each clinic from baseline to 6 months, and then described the mean change across clinics by group. As with our other outcomes, the unit of analysis in the study is a clinic.
Measured: baseline and 6 months
Change in Blood Pressure Controlled to 2017 Guideline Goal, % of Patients
This alternative overall measure of BP control is identical to Metric 1, except that attainment of BP Control is defined by SBP < 130 mmHg and DBP < 80 mmHg, as per the goal stated in the 2017 ACC/AHA Hypertension Guideline[ref]. Note that while the treatment threshold varies in the Guideline, depending on cardiovascular risk, the goal applies to all patients.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Jul 2019
- Primary completion28 Feb 2021
- Study completion30 Jun 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,238,835 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- OCHIN, Inc., Louisiana Public Health Institute, American Medical Association, American Heart Association
- Responsible party
- Sponsor
- Investigators
- Mark Pletcher, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818659
- Sponsor's protocol ID
- 18-25890
- Acronym
- BP MAP
- Status last verified
- Feb 2025
- First submitted
- 22 Jan 2019
- Last updated
- 3 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fontil V, Modrow MF, Cooper-DeHoff RM, Wozniak G, Rakotz M, Todd J, Azar K, Murakami L, Sanders M, Chamberlain AM, O'Brien E, Lee A, Carton T, Pletcher MJ. Improvement in Blood Pressure Control in Safety Net Clinics Receiving 2 Versions of a Scalable Quality Improvement Intervention: BP MAP A Pragmatic Cluster Randomized Trial. J Am Heart Assoc. 2023 Feb 7;12(3):e024975. doi: 10.1161/JAHA.121.024975. Epub 2023 Jan 25.
PubMed 36695297
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Blood Pressure Control in Diverse Populations by Measuring Accurately, Acting Rapidly, and Partnering With Patients
- ClinicalTrials.gov ID
- NCT03818659
- Acronym / sponsor ID
- BP MAP / 18-25890
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,238,835 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- OCHIN, Inc., Louisiana Public Health Institute, American Medical Association, American Heart Association
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 3 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BP-MAP is a cluster randomized controlled trial (RCT) designed to compare the effectiveness of BP lowering from a clinic-based quality improvement program with Full Support (dedicated practice facilitation) vs. a Self-Guided version of the program. The American Medical Association (AMA) developed the framework for the interventions.
Detailed description
BP-MAP is a cluster randomized controlled trial (RCT) designed to compare the effectiveness of BP lowering from a clinic-based quality improvement program with Full Support (dedicated practice facilitation) vs. a Self-Guided version of the program. The American Medical Association (AMA) developed the framework for the interventions. The trial will be conducted within the National Patient-Centered Clinical Research Network (PCORnet) that enables distributed querying of electronic health record data in a common data model. The primary outcome will be change in clinic-level blood pressure (BP) control at 6 months. Secondary outcomes will include other blood pressure (BP) control metrics, other time points (12 and 18 months), and process measures such as BP measurement accuracy, medication intensification, and average systolic blood pressure (SBP) reduction after a medication intensification, and repeat visit within 4 weeks after a visit with elevated BP. The investigators hypothesize clinics randomized to the Full Support version will achieve a larger increase from baseline in the proportion of their hypertensive patients with controlled BP at 6 months as compared to clinics randomized to the Self-Guided version, and also as compared with usual care. The investigators will also conduct non-randomized comparisons of BP control in the Full Support and Self-Guided intervention arms to BP control in non-participating "Usual Care" institutions in PCORnet. This study was submitted to the IRB at UCSF, determined to be quality improvement and exempt from further review.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-Guided | Active comparator | Other: Self-Guided M.A.P. BP Improvement ProgramActive Clinics randomized to the Self-Guided Arm will receive access to an AHA/AMA web platform that includes the posted M.A.P. materials and limited access to AMA Staff who are available to answer questions. The study team will facilitate access to staff by hosting a kick-off webinar for program participants that will include an orientation to the materials on the website, general advice and practical tips about what works for implementation, and time for answering questions and discussion with the group. |
| Full Support | Experimental | Other: Full Support M.A.P. BP Improvement ProgramActive Clinics randomized to the Full Support Arm will receive online access to M.A.P. materials and orientation webinar and also a Practice Change Facilitator who will lead the health center clinical staff, site champions and physician leads at each clinic over the course of 6 months to support the implementation of the MAP Program. With support from an AMA "Improvement Advisor", the Practice Change Facilitators will perform a baseline assessment of current workflows and assess each domain of M.A.P. The goal of the Full Support program is to help care teams develop skills and sustainable workflows that are effective at attaining and maintaining high levels of BP control. |
| Usual Care | No intervention | –The investigators will also conduct non-randomized comparisons of BP control in the Full Support and Self-Guided intervention arms to BP control in non-participating "Usual Care" institutions in PCORnet. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Self-Guided M.A.P. BP Improvement ProgramActive Clinics randomized to the Self-Guided Arm will receive access to an AHA/AMA web platform that includes the posted M.A.P. materials and limited access to AMA Staff who are available to answer questions. The study team will facilitate access to staff by hosting a kick-off webinar for program participants that will include an orientation to the materials on the website, general advice and practical tips about what works for implementation, and time for answering questions and discussion with the group. | Other | Self-Guided |
| Full Support M.A.P. BP Improvement ProgramActive Clinics randomized to the Full Support Arm will receive online access to M.A.P. materials and orientation webinar and also a Practice Change Facilitator who will lead the health center clinical staff, site champions and physician leads at each clinic over the course of 6 months to support the implementation of the MAP Program. With support from an AMA "Improvement Advisor", the Practice Change Facilitators will perform a baseline assessment of current workflows and assess each domain of M.A.P. The goal of the Full Support program is to help care teams develop skills and sustainable workflows that are effective at attaining and maintaining high levels of BP control. | Other | Full Support |
Primary outcome
Change in Blood Pressure Control, % of Patients
Time frame: baseline and 6 months
The primary outcome will be clinic-level change in the proportion of patients with controlled BP from baseline to 6 months after the start of the intervention. BP control will be defined according to NQF 0018 as the percent of eligible patients (defined below) with SBP <140 mmHg and DBP < 90 mmHg, based on measurements obtained at the most recent ambulatory clinical encounter at baseline (using the lowest measures of SBP and DBP at that encounter) and similarly at the 6-month time point after initiation of the intervention.
9 secondary outcomes
Change in Improvement in Blood Pressure, % of Patients
Time frame: baseline and 12 months
Change in Confirmatory Repeated Blood Pressure Measurement, % of Visits
Time frame: baseline and 6 months
Change in Medication Intensification, % of Visits
Time frame: baseline and 6 months
Change in Average Systolic Blood Pressure (SBP) Reduction After a Medication Intensification Visit, mmHg
Time frame: baseline and 6 months
Change in Repeat Visit in 4 Weeks After a Visit With Elevated BP, % of Visits
Time frame: baseline and 6 months
Change in Use of Fixed Dose Combination Product Among Patients Taking 2 or More Classes of Medications, % of Patients
Time frame: baseline and 6 months
Change in Use of a CCB or Thiazide or Thiazide-like Diuretic Among African-American Patients on at Least One Medication, % of Patients
Time frame: baseline and 6 months
Change in Terminal Digit = Zero, % of Measurements
Time frame: baseline and 6 months
Change in Blood Pressure Controlled to 2017 Guideline Goal, % of Patients
Time frame: baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36695297Fontil V, Modrow MF, Cooper-DeHoff RM, Wozniak G, Rakotz M, Todd J, Azar K, Murakami L, Sanders M, Chamberlain AM, O'Brien E, Lee A, Carton T, Pletcher MJ. Improvement in Blood Pressure Control in Safety Net Clinics Receiving 2 Versions of a Scalable Quality Improvement Intervention: BP MAP A Pragmatic Cluster Randomized Trial. J Am Heart Assoc. 2023 Feb 7;12(3):e024975. doi: 10.1161/JAHA.121.024975. Epub 2023 Jan 25.
- Individual participant dataSharing planned: No
Related trials for Hypertension
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruitingPhase 2
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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.
Mark Pletcher, MD, MPH principal investigator
University of California, San Francisco
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Guided M.A.P. BP Improvement Program and Full Support M.A.P. BP Improvement Program in people with Hypertension, run by University of California, San Francisco at 24 sites 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?
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 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2025). 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 in Blood Pressure Control, % of Patients (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03818659, which also lists 1 linked publication.
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 3 Mar 2025.