HypertensionIMPACTSNCT03483662
Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS)
A study testing Multicomponent Intervention in people with Hypertension and Blood Pressure, run by Tulane University at 2 sites in United States.
Trial summary
The IMPACTS study utilizes an effectiveness-implementation hybrid type 2 design to achieve two primary goals simultaneously: 1). to test the effectiveness of a multifaceted implementation strategy for intensive BP control among underserved hypertensive patients at high risk for CVD, and 2). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension, Blood Pressure
- What is being tested?
- Multicomponent Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,272 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jun 2018to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged ≥40 years who receive primary care from the participating FQHC clinics.
- Systolic BP ≥140 mmHg at two screening visits for those not taking antihypertensive medication or systolic BP ≥ 130 mmHg at two screening visits for those taking antihypertensive medications.
Who cannot join
- Not able to understand English
- Pregnant women, women planning to become pregnant in the next 18 months, women of childbearing potential and not practicing birth control, and persons who cannot give informed consent.
- Plans to change to a primary healthcare provider outside of the FQHC clinic during the next 18 months.
- Diagnosis of end-stage renal disease, defined as dialysis or transplantation.
- Individuals unlikely to complete the study, such as those who plan to move out the study area during the next 18 months, temporary migrant workers, and homeless persons.
- Patients with immediate family members who are staff at their FQHC clinic.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
10 FQHC Primary Care Clinics in Mississippi
Biloxi, Mississippi, 39530
26 FQHC Primary Care Clinics in Louisiana
New Orleans, Louisiana, 70112
About this study
Official title: Dissemination and Implementation of the SPRINT Study Findings in Underserved Populations
The IMPACTS study utilizes an effectiveness-implementation hybrid type 2 design to achieve two primary goals simultaneously: 1). to test the effectiveness of a multifaceted implementation strategy for intensive BP control among underserved hypertensive patients at high risk for CVD, and 2). to assess the implementation outcomes of the multifaceted implementation strategy in patients and providers.
Read the detailed description
Recently, the Systolic Blood Pressure Intervention Trial (SPRINT) reported that more intensive blood pressure (BP) treatment (target systolic BP<120 mm Hg) reduced major cardiovascular disease (CVD) by about 25% and all-cause mortality by about 27% compared to standard BP treatment (target systolic BP<140 mm Hg) among hypertensive patients aged ≥50 years. SPRINT clearly answered the question - Will lowering BP more than the currently recommended goal further reduce the risk of CVD and mortality? The next important question is how to implement a more intensive BP treatment program in real-world clinical practice, especially in underserved patients. The IMPACTS trial is an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multicomponent intervention program for more intensive BP treatment and the feasibility and fidelity of implementing the program in underserved patients with hypertension in Louisiana and Mississippi. The Consolidated Framework for Implementation Research has been used to guide the development of the multicomponent intervention, including dissemination of SPRINT study findings among patients, providers and policymakers; team-based collaborative care using a stepped-care protocol adapted from the SPRINT intensive-treatment algorithm, BP audit and feedback, and home BP monitoring; and health coaching on antihypertensive medication adherence and lifestyle modification. The investigators will collaborate with 36 federally qualified health center clinics that serve low-income populations in Louisiana and Mississippi to recruit 1,260 trial participants and conduct the IMPACTS trial. The primary clinical outcome is the difference in mean change of systolic BP from baseline to 18 months. The fidelity of the intervention, measured by intensification of treatment by providers and adherence to medications in patients, will be the primary implementation outcome. This study will generate urgently needed data on effective and adoptable intervention strategies aimed at eliminating health disparities and reducing the BP-related disease burden in underserved populations in the US.
- Conditions
- Hypertension, Blood Pressure
- Being tested
- Multicomponent Intervention, Enhanced Usual Care
- Keywords
- hypertension, blood pressure, medication adherence, lifestyle modification, blood pressure control, implementation
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent InterventionBehavioural
The core component of the intervention is protocol-based treatment using the SPRINT BP management algorithm. The following implementation strategies are adaptable components that will be modified to fit specific federally-qualified health center (FQHC) settings: dissemination of SPRINT study findings among provider-teams, patients, and administrators, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification.
Enhanced Usual CareBehavioural
The investigators will provide an up-to-date clinical guideline for hypertension management to providers. A webinar education session on the new American College of Cardiology (ACC)/American Heart Association (AHA) hypertension guideline and findings from the SPRINT trial will be conducted. Otherwise, the investigators will not conduct any active intervention and all control clinics will follow their routine clinic practice in the management of hypertensive patients
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Intervention | Experimental | Protocol-based treatment using the SPRINT stepped-care intensive BP management algorithm, dissemination of SPRINT study findings among provider-teams, patients, and administrators, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification Receives: Behavioral: Multicomponent Intervention |
| Enhanced Usual Care | Active comparator | Webinar education session for providers on the new ACC/AHA hypertensive clinical guideline and the SPRINT study findings Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean change of systolic BP
The primary outcome is the difference in mean change of systolic blood pressure from baseline to 18 months between intervention and control groups. Blood pressure will be measured 3 times each at two baseline, one 6-month, one 12-month, and two termination visits according to a standard protocol.
Measured: Baseline to 18 months
Difference in a fidelity summary score for key implementation strategy components during the 18-month intervention.
A fidelity summary score includes adherence to antihypertensive medications, initiation or intensification of treatment, home BP monitoring, and health education over the intervention period. The fidelity summary score ranges from 0 (worst) to 4 (best)
Measured: Baseline to 18 months
Secondary outcomes (14)
Proportion of patients with systolic blood pressure <120 mm Hg
The differences in the proportion of patients with systolic blood pressure <120 mm Hg between the intervention and control groups at 18 months will be assessed.
Measured: Baseline to 18 months
Proportion of patients with systolic blood pressure <130 mm Hg
The differences in the proportion of patients with systolic blood pressure <130 mm Hg between the intervention and control groups at 18 months will be assessed.
Measured: Baseline to 18 months
Proportion of patients with a >30 mm Hg reduction in systolic blood pressure
The differences in the proportion of patients with a >30 mm Hg reduction in systolic blood pressure between the intervention and control groups at 18 months will be assessed.
Measured: Baseline to 18 months
Difference in mean change of diastolic blood pressure
The difference in mean change of diastolic blood pressure from baseline to 18 months between intervention and control groups will be assessed.
Measured: Baseline to 18 months
Health-related quality of life (SF-12)
Health-related quality of life will be assessed using the 12-Item Short Form Survey (SF-12). Physical component summary (PCS-12) and mental component summary (MCS-12) scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: Baseline to 18 months
Intensification of treatment (fidelity)
Survey data and electronic health record data will be used to assess whether providers add new antihypertensive medications or titrate existing medications. Intensification of antihypertension treatment is a binary outcome variable, with 1 representing the initiation of a new medication or an increase in the current medication dosage, and 0 representing no change in medication.
Measured: Baseline to 18 months
Medication adherence (fidelity)
Patient medication adherence will be assessed by questionnaire. Binary variable: 1=high adherence and 0=low adherence
Measured: Baseline to 18 months
Self-reported home BP monitoring (fidelity)
Patient home BP monitoring will be assessed by questionnaire. Binary variable: 1=yes and 0=no
Measured: Baseline to 18 months
Self-reported health education at previous clinic visits (fidelity)
Patient health education at previous clinic visits will be assessed by questionnaire. Binary variable: 1=yes and 0=no.
Measured: Baseline to 18 months
Satisfaction with antihypertensive medications
The satisfaction of patients with antihypertensive medications was assessed at baseline and follow-up visits using the question, 'How satisfied are you with antihypertensive medications you have received?' There are five possible answers: 'very satisfied,' 'satisfied,' 'neutral,' 'dissatisfied,' and 'very dissatisfied'.
Measured: Baseline to 18 months
Satisfaction with BP-related care
The satisfaction of patients with BP-related care was assessed at baseline and follow-up visits using the question, 'How satisfied are you with the care you have received for your blood pressure?' There are five possible answers: 'very satisfied,' 'satisfied,' 'neutral,' 'dissatisfied,' and 'very dissatisfied'.
Measured: Baseline to 18 months
Acceptance to intensive BP target by providers in intervention clinics
Survey among providers
Measured: Baseline to 18 months
Adherence to clinical appointments in the intervention group
Study administrative data
Measured: Baseline to 18 months
Adherence to health coach session in the intervention group
Study administrative data
Measured: Baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start27 Jun 2018
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- 1,272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jiang He, MD, PhD, Tulane University
- Investigators
- Jiang He, MD, PhD, Principal investigator, Tulane UniversityMarie A Krousel-Wood, MD, MPH, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483662
- Sponsor's protocol ID
- R01HL133790
- Other IDs
- R01HL133790
- Acronym
- IMPACTS
- Status last verified
- Aug 2023
- First submitted
- 24 Mar 2018
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository. The study data will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." At the completion of the project, the investigators will make all intervention materials and procedure manuals available to the public according to the approved plan for making data and materials available to the scientific community, lay public, and the NIH.
Publications
Mills KT, Krousel-Wood M, Peacock EM, Chen J, Allouch F, Carreras AK, Geng S, Cyprian A, Davis G, Fuqua SR, Gilliam D, Greer A, Mitchell T, Gray-Winfrey W, Williams S, Wiltz GM, Winfrey KL, He H, Whelton PK, He J. Multifaceted Strategies for Hypertension Control in Low-Income Patients. N Engl J Med. 2026 Apr 9;394(14):1376-1387. doi: 10.1056/NEJMoa2504068.
PubMed 41950472Mills KT, Peacock E, Chen J, Zimmerman A, He H, Cyprian A, Davis G, Fuqua SR, Gilliam DS, Greer A, Gray-Winfrey L, Williams S, Wiltz GM, Winfrey KL, Whelton PK, Krousel-Wood M, He J. Experiences and Beliefs of Low-Income Patients With Hypertension in Louisiana and Mississippi During the COVID-19 Pandemic. J Am Heart Assoc. 2021 Feb 2;10(3):e018510. doi: 10.1161/JAHA.120.018510. Epub 2020 Dec 3.
PubMed 33267723Mills KT, Peacock E, Chen J, Zimmerman A, Brooks K, He H, Cyprian A, Davis G, Fuqua SR, Greer A, Gray-Winfrey L, Williams S, Wiltz GM, Winfrey KL, Whelton PK, Krousel-Wood M, He J. Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial. Am Heart J. 2020 Dec;230:13-24. doi: 10.1016/j.ahj.2020.08.009. Epub 2020 Aug 19.
PubMed 32827458
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination and Implementation of the SPRINT Study Findings in Underserved Populations
- ClinicalTrials.gov ID
- NCT03483662
- Acronym / sponsor ID
- IMPACTS / R01HL133790
- Conditions
- Hypertension, Blood Pressure
- Keywords
- hypertension, blood pressure, medication adherence, lifestyle modification, blood pressure control, implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,272 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The IMPACTS study utilizes an effectiveness-implementation hybrid type 2 design to achieve two primary goals simultaneously: 1). to test the effectiveness of a multifaceted implementation strategy for intensive BP control among underserved hypertensive patients at high risk for CVD, and 2). to assess the implementation outcomes of the multifaceted implementation strategy in patients and providers.
Detailed description
Recently, the Systolic Blood Pressure Intervention Trial (SPRINT) reported that more intensive blood pressure (BP) treatment (target systolic BP<120 mm Hg) reduced major cardiovascular disease (CVD) by about 25% and all-cause mortality by about 27% compared to standard BP treatment (target systolic BP<140 mm Hg) among hypertensive patients aged ≥50 years. SPRINT clearly answered the question - Will lowering BP more than the currently recommended goal further reduce the risk of CVD and mortality? The next important question is how to implement a more intensive BP treatment program in real-world clinical practice, especially in underserved patients. The IMPACTS trial is an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multicomponent intervention program for more intensive BP treatment and the feasibility and fidelity of implementing the program in underserved patients with hypertension in Louisiana and Mississippi. The Consolidated Framework for Implementation Research has been used to guide the development of the multicomponent intervention, including dissemination of SPRINT study findings among patients, providers and policymakers; team-based collaborative care using a stepped-care protocol adapted from the SPRINT intensive-treatment algorithm, BP audit and feedback, and home BP monitoring; and health coaching on antihypertensive medication adherence and lifestyle modification. The investigators will collaborate with 36 federally qualified health center clinics that serve low-income populations in Louisiana and Mississippi to recruit 1,260 trial participants and conduct the IMPACTS trial. The primary clinical outcome is the difference in mean change of systolic BP from baseline to 18 months. The fidelity of the intervention, measured by intensification of treatment by providers and adherence to medications in patients, will be the primary implementation outcome. This study will generate urgently needed data on effective and adoptable intervention strategies aimed at eliminating health disparities and reducing the BP-related disease burden in underserved populations in the US.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Intervention | Experimental | Behavioral: Multicomponent InterventionProtocol-based treatment using the SPRINT stepped-care intensive BP management algorithm, dissemination of SPRINT study findings among provider-teams, patients, and administrators, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareWebinar education session for providers on the new ACC/AHA hypertensive clinical guideline and the SPRINT study findings |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women aged ≥40 years who receive primary care from the participating FQHC clinics.
- Systolic BP ≥140 mmHg at two screening visits for those not taking antihypertensive medication or systolic BP ≥ 130 mmHg at two screening visits for those taking antihypertensive medications.
Key exclusion criteria (6 listed)
- Not able to understand English
- Pregnant women, women planning to become pregnant in the next 18 months, women of childbearing potential and not practicing birth control, and persons who cannot give informed consent.
- Plans to change to a primary healthcare provider outside of the FQHC clinic during the next 18 months.
- Diagnosis of end-stage renal disease, defined as dialysis or transplantation.
- Individuals unlikely to complete the study, such as those who plan to move out the study area during the next 18 months, temporary migrant workers, and homeless persons.
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 |
|---|---|---|
| Multicomponent InterventionThe core component of the intervention is protocol-based treatment using the SPRINT BP management algorithm. The following implementation strategies are adaptable components that will be modified to fit specific federally-qualified health center (FQHC) settings: dissemination of SPRINT study findings among provider-teams, patients, and administrators, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification. | Behavioural | Multicomponent Intervention |
| Enhanced Usual CareThe investigators will provide an up-to-date clinical guideline for hypertension management to providers. A webinar education session on the new American College of Cardiology (ACC)/American Heart Association (AHA) hypertension guideline and findings from the SPRINT trial will be conducted. Otherwise, the investigators will not conduct any active intervention and all control clinics will follow their routine clinic practice in the management of hypertensive patients | Behavioural | Enhanced Usual Care |
Primary outcome
Difference in mean change of systolic BP
Time frame: Baseline to 18 months
The primary outcome is the difference in mean change of systolic blood pressure from baseline to 18 months between intervention and control groups. Blood pressure will be measured 3 times each at two baseline, one 6-month, one 12-month, and two termination visits according to a standard protocol.
Difference in a fidelity summary score for key implementation strategy components during the 18-month intervention.
Time frame: Baseline to 18 months
A fidelity summary score includes adherence to antihypertensive medications, initiation or intensification of treatment, home BP monitoring, and health education over the intervention period. The fidelity summary score ranges from 0 (worst) to 4 (best)
14 secondary outcomes
Proportion of patients with systolic blood pressure <120 mm Hg
Time frame: Baseline to 18 months
Proportion of patients with systolic blood pressure <130 mm Hg
Time frame: Baseline to 18 months
Proportion of patients with a >30 mm Hg reduction in systolic blood pressure
Time frame: Baseline to 18 months
Difference in mean change of diastolic blood pressure
Time frame: Baseline to 18 months
Health-related quality of life (SF-12)
Time frame: Baseline to 18 months
Intensification of treatment (fidelity)
Time frame: Baseline to 18 months
Medication adherence (fidelity)
Time frame: Baseline to 18 months
Self-reported home BP monitoring (fidelity)
Time frame: Baseline to 18 months
Self-reported health education at previous clinic visits (fidelity)
Time frame: Baseline to 18 months
Satisfaction with antihypertensive medications
Time frame: Baseline to 18 months
Satisfaction with BP-related care
Time frame: Baseline to 18 months
Acceptance to intensive BP target by providers in intervention clinics
Time frame: Baseline to 18 months
Adherence to clinical appointments in the intervention group
Time frame: Baseline to 18 months
Adherence to health coach session in the intervention group
Time frame: Baseline to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Derived from this study: PubMed 41950472Mills KT, Krousel-Wood M, Peacock EM, Chen J, Allouch F, Carreras AK, Geng S, Cyprian A, Davis G, Fuqua SR, Gilliam D, Greer A, Mitchell T, Gray-Winfrey W, Williams S, Wiltz GM, Winfrey KL, He H, Whelton PK, He J. Multifaceted Strategies for Hypertension Control in Low-Income Patients. N Engl J Med. 2026 Apr 9;394(14):1376-1387. doi: 10.1056/NEJMoa2504068.
- Derived from this study: PubMed 33267723Mills KT, Peacock E, Chen J, Zimmerman A, He H, Cyprian A, Davis G, Fuqua SR, Gilliam DS, Greer A, Gray-Winfrey L, Williams S, Wiltz GM, Winfrey KL, Whelton PK, Krousel-Wood M, He J. Experiences and Beliefs of Low-Income Patients With Hypertension in Louisiana and Mississippi During the COVID-19 Pandemic. J Am Heart Assoc. 2021 Feb 2;10(3):e018510. doi: 10.1161/JAHA.120.018510. Epub 2020 Dec 3.
- Derived from this study: PubMed 32827458Mills KT, Peacock E, Chen J, Zimmerman A, Brooks K, He H, Cyprian A, Davis G, Fuqua SR, Greer A, Gray-Winfrey L, Williams S, Wiltz GM, Winfrey KL, Whelton PK, Krousel-Wood M, He J. Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial. Am Heart J. 2020 Dec;230:13-24. doi: 10.1016/j.ahj.2020.08.009. Epub 2020 Aug 19.
- Individual participant dataSharing planned: Yes. The study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository. The study data will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." At the completion of the project, the investigators will make all intervention materials and procedure manuals available to the public according to the approved plan for making data and materials available to the scientific community, lay public, and the NIH.
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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.
Jiang He, MD, PhD principal investigator
Tulane University
Marie A Krousel-Wood, MD, MPH principal investigator
Tulane University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Intervention in people with Hypertension and Blood Pressure, run by Tulane University at 2 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?
The sponsor lists 2 inclusion and 6 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 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in mean change of systolic BP (time frame: Baseline to 18 months). The study lists 2 primary outcomes in all. 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 NCT03483662, which also lists 3 linked publications.
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 9 Jul 2025.