HypertensionCOBRA-BPSNCT02657746
Primary Care Strategies to Reduce High Blood Pressure: A Cluster Randomized Trial in Rural Bangladesh, Pakistan and Sri Lanka
A study testing multi-component interventions in people with Hypertension, run by Duke-NUS Graduate Medical School.
Trial summary
Background: High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension remains to be a significant public health issue with sub-optimal rates of case finding and management. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- multi-component interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,550 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to Mar 2020
- 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
- Age≥ 40 years
- Residing in the selected clusters
- Hypertension defined either as:
- Persistently elevated BP (systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg) from each set of last 2 of 3 readings from 2 separate days
- maintained on anti-hypertensive medications
- Informed consent
Who cannot join
- Permanently bed-ridden individuals too ill to commute to the clinic
- Pregnancy, or individuals with advanced medical disease (on dialysis, liver failure, other systemic diseases)
- Individuals that are mentally compromised and unable to give informed consent
- Sub-study:
- 1) fulfill all criteria of main study and, 2) Persistently elevated systolic BP >160 mm Hg or diastolic BP >100 mm Hg from each set of 2 readings from 2 separate days
- -
About this study
Official title: Control of Blood Pressure and Risk Attenuation-Bangladesh, Pakistan and Sri Lanka (COBRA-BPS)
Background: High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension remains to be a significant public health issue with sub-optimal rates of case finding and management. The goal of the full-scale study is to evaluate the effectiveness and cost-effectiveness of multicomponent primary care strategies on lowering blood pressure among adults with hypertension in rural communities in Bangladesh, Pakistan, and Sri Lanka.
Methods/Design: The mixed-methods, stratified cluster randomized controlled trial
Read more
Intervention: The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension.
Usual care: Will comprise existing services in the community without any additional training.
Participants: The trial will be conducted on 2550 individuals aged 40 years or older with hypertension (systolic BP ≥ 140 mm Hg or diastolic BP≥ 90 mm Hg, or on antihypertensive therapy) in 30 rural communities of Bangladesh, Pakistan and Sri Lanka. Out of the 2550 individuals, 420 with poorly controlled BP (Systolic BP≥160 mmHg or Diastolic BP≥100 mmHg) will be selected, 14 from each community, to investigate the effect of MCI on results from ambulatory BP monitoring.
Qualitative component: Stakeholders including policymakers, district managers, and community health workers, GPs, hypertensive individuals and family members in the identified clusters will be surveyed.
Outcome: The primary outcome will be change in systolic BP from baseline to follow-up at 24 months post randomization. The cost effectiveness outcome is the incremental cost of MCI per unit reduction in BP over the two year time period and in terms of incremental cost per CVD DALYs averted.
- Conditions
- Hypertension
- Being tested
- multi-component interventions
- Keywords
- blood pressure monitoring, high blood pressure, cardiovascular disease, Antihypertensive agents, Non-pharmacological treatment, community health care workers, cost-effectiveness
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-component interventionsOther
The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension.
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | Usual care comprises existing services for hypertension control in the community without any additional training |
| multi-component interventions | Experimental | : The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension. Receives: Other: multi-component interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure reading:change in systolic blood pressure (SBP) from baseline to follow-up at 24 months post randomization.
Measured: Blood pressure (BP) will measured at baseline and then at 6-month intervals until 24 months after randomization
Secondary outcomes (20)
Blood pressure reading:Blood Pressure(BP) controlled to target (Systolic BP <140 mm Hg and Diastolic BP <90 mm
Measured: at 6-month intervals over 24 months
Questionnaire:Composite outcome of death (all cause), or hospital admission due to coronary heart disease (CHD), heart failure, or stroke
Measured: 24 months
Questionnaire and EQ-5D-5L:Incremental cost per quality-adjusted life-year (QALY) gained from baseline to end of follow-up
Measured: 24 months
Morisky Medication Adherence Scale(MMAS):Change in antihypertensive medication adherence (Morisky score)
Measured: 24 months
Height and weight measurements:change in body mass index ( BMI)
Measured: 24 months
questionnaire:change dietary salt intake (urinary excretion)
Measured: 24 months
Questionnaire:change in prevalence of current smokers
Measured: 24 months
Questionnaire:incident diabetes
Measured: 24 months
Lipid panel: change in serum lipid levels
Measured: 24 months
questionnaire: change in INTERHEART cardiovascular disease (CVD) risk score
Measured: 24 months
Questionnaire:incidence of adverse outcomes (medication side effects, sick days absenteeism, low QALY between randomized groups).
Measured: 24 months
Questionnaire and serum creatinine:Change in estimated glomerular filtration rate (eGFR)
Measured: 24 months
Urine albumin:Change in urine albumin
Measured: 24 months
24 hours mean diastolic BP
Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
Measured: 24 months
Daytime SBP/DBP
secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
Measured: 24 months
Night time SBP/DBP
Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
Measured: 24 months
Dipping Pattern
Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
Measured: 24 months
24 hour BP variability
Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
Measured: 24 months
Questionnaire and EQ-5D-5L:Incremental cost per mm Hg BP reduction from baseline to end of follow-up at two years post randomization and incremental cost per projected cardiovascular disease ( CVD) disability adjusted life year (DALY) averted
Measured: information on healthcare cost will be collected at baseline and 24 months
incremental cost per mm Hg BP reduction from baseline to end of follow-up at 2 years post-randomization and incremental cost per projected CVD disability-adjusted life year (DALY) averted
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study start1 May 2016
- Primary completionMar 2019
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Aga Khan University, University of Kelaniya
- Responsible party
- Principal investigator, Professor Tazeen Jafar, Duke-NUS Graduate Medical School
- Investigators
- Tazeen H Jafar, MD,MPH, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657746
- Sponsor's protocol ID
- MR/N006178/1
- Acronym
- COBRA-BPS
- Status last verified
- Oct 2019
- First submitted
- 14 Jan 2016
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Feng L, Jehan I, de Silva HA, Naheed A, Khan AH, Kasturiratne A, Clemens JD, Lim CW, Hughes AD, Chaturvedi N, Jafar TH. Effect of a Multicomponent Intervention on Antihypertensive Medication Intensification in Rural South Asia: Post Hoc Analysis of a Cluster RCT. Am J Hypertens. 2021 Sep 22;34(9):981-988. doi: 10.1093/ajh/hpab072.
PubMed 34013966Jafar TH, Gandhi M, de Silva HA, Jehan I, Naheed A, Finkelstein EA, Turner EL, Morisky D, Kasturiratne A, Khan AH, Clemens JD, Ebrahim S, Assam PN, Feng L; COBRA-BPS Study Group. A Community-Based Intervention for Managing Hypertension in Rural South Asia. N Engl J Med. 2020 Feb 20;382(8):717-726. doi: 10.1056/NEJMoa1911965.
PubMed 32074419Perera M, de Silva CK, Tavajoh S, Kasturiratne A, Luke NV, Ediriweera DS, Ranasinha CD, Legido-Quigley H, de Silva HA, Jafar TH. Patient perspectives on hypertension management in health system of Sri Lanka: a qualitative study. BMJ Open. 2019 Oct 7;9(10):e031773. doi: 10.1136/bmjopen-2019-031773.
PubMed 31594895Gandhi M, Assam PN, Turner EL, Morisky DE, Chan E, Jafar TH; COBRA-BPS Study Group. Statistical analysis plan for the control of blood pressure and risk attenuation-rural Bangladesh, Pakistan, Sri Lanka (COBRA-BPS) trial: a cluster randomized trial for a multicomponent intervention versus usual care in hypertensive patients. Trials. 2018 Nov 29;19(1):658. doi: 10.1186/s13063-018-3022-8.
PubMed 30486858Feng L, de Silva HA, Jehan I, Naheed A, Kasturiratne A, Himani G, Hasnat MA, Jafar TH. Regional variation in chronic kidney disease and associated factors in hypertensive individuals in rural South Asia: findings from control of blood pressure and risk attenuation-Bangladesh, Pakistan and Sri Lanka. Nephrol Dial Transplant. 2019 Oct 1;34(10):1723-1730. doi: 10.1093/ndt/gfy184.
PubMed 29982770Jafar TH, Gandhi M, Jehan I, Naheed A, de Silva HA, Shahab H, Alam D, Luke N, Wee Lim C; COBRA-BPS Study Group. Determinants of Uncontrolled Hypertension in Rural Communities in South Asia-Bangladesh, Pakistan, and Sri Lanka. Am J Hypertens. 2018 Oct 15;31(11):1205-1214. doi: 10.1093/ajh/hpy071.
PubMed 29701801Jafar TH, Jehan I, de Silva HA, Naheed A, Gandhi M, Assam P, Finkelstein EA, Quigley HL, Bilger M, Khan AH, Clemens JD, Ebrahim S, Turner EL; for COBRA-BPS Study Group; Kasturiratne A. Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial. Trials. 2017 Jun 12;18(1):272. doi: 10.1186/s13063-017-2018-0.
PubMed 28606184
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Blood Pressure and Risk Attenuation-Bangladesh, Pakistan and Sri Lanka (COBRA-BPS)
- ClinicalTrials.gov ID
- NCT02657746
- Acronym / sponsor ID
- COBRA-BPS / MR/N006178/1
- Conditions
- Hypertension
- Keywords
- blood pressure monitoring, high blood pressure, cardiovascular disease, Antihypertensive agents, Non-pharmacological treatment, community health care workers, cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,550 participants (estimated)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Aga Khan University, University of Kelaniya
- Study start
- 1 May 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2020 (estimated)
- First posted
- 18 Jan 2016 (estimated)
- 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.
Background: High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension remains to be a significant public health issue with sub-optimal rates of case finding and management. The goal of the full-scale study is to evaluate the effectiveness and cost-effectiveness of multicomponent primary care strategies on lowering blood pressure among adults with hypertension in rural communities in Bangladesh, Pakistan, and Sri Lanka.
Methods/Design: The mixed-methods, stratified cluster randomized controlled trial
Intervention: The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension.
Usual care: Will comprise existing services in the community without any additional training.
Participants: The trial will be conducted on 2550 individuals aged 40 years or older with hypertension (systolic BP ≥ 140 mm Hg or diastolic BP≥ 90 mm Hg, or on antihypertensive therapy) in 30 rural communities of Bangladesh, Pakistan and Sri Lanka. Out of the 2550 individuals, 420 with poorly controlled BP (Systolic BP≥160 mmHg or Diastolic BP≥100 mmHg) will be selected, 14 from each community, to investigate the effect of MCI on results from ambulatory BP monitoring.
Qualitative component: Stakeholders including policymakers, district managers, and community health workers, GPs, hypertensive individuals and family members in the identified clusters will be surveyed.
Outcome: The primary outcome will be change in systolic BP from baseline to follow-up at 24 months post randomization. The cost effectiveness outcome is the incremental cost of MCI per unit reduction in BP over the two year time period and in terms of incremental cost per CVD DALYs averted.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –Usual care comprises existing services for hypertension control in the community without any additional training |
| multi-component interventions | Experimental | Other: multi-component interventions: The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age≥ 40 years
- Residing in the selected clusters
- Hypertension defined either as:
- Informed consent
Key exclusion criteria (6 listed)
- Permanently bed-ridden individuals too ill to commute to the clinic
- Pregnancy, or individuals with advanced medical disease (on dialysis, liver failure, other systemic diseases)
- Individuals that are mentally compromised and unable to give informed consent
- 1) fulfill all criteria of main study and, 2) Persistently elevated systolic BP >160 mm Hg or diastolic BP >100 mm Hg from each set of 2 readings from 2 separate days
- -
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 |
|---|---|---|
| multi-component interventionsThe multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension. | Other | multi-component interventions |
Primary outcome
Blood pressure reading:change in systolic blood pressure (SBP) from baseline to follow-up at 24 months post randomization.
Time frame: Blood pressure (BP) will measured at baseline and then at 6-month intervals until 24 months after randomization
20 secondary outcomes
Blood pressure reading:Blood Pressure(BP) controlled to target (Systolic BP <140 mm Hg and Diastolic BP <90 mm
Time frame: at 6-month intervals over 24 months
Questionnaire:Composite outcome of death (all cause), or hospital admission due to coronary heart disease (CHD), heart failure, or stroke
Time frame: 24 months
Questionnaire and EQ-5D-5L:Incremental cost per quality-adjusted life-year (QALY) gained from baseline to end of follow-up
Time frame: 24 months
Morisky Medication Adherence Scale(MMAS):Change in antihypertensive medication adherence (Morisky score)
Time frame: 24 months
Height and weight measurements:change in body mass index ( BMI)
Time frame: 24 months
questionnaire:change dietary salt intake (urinary excretion)
Time frame: 24 months
Questionnaire:change in prevalence of current smokers
Time frame: 24 months
Questionnaire:incident diabetes
Time frame: 24 months
Lipid panel: change in serum lipid levels
Time frame: 24 months
questionnaire: change in INTERHEART cardiovascular disease (CVD) risk score
Time frame: 24 months
Questionnaire:incidence of adverse outcomes (medication side effects, sick days absenteeism, low QALY between randomized groups).
Time frame: 24 months
Questionnaire and serum creatinine:Change in estimated glomerular filtration rate (eGFR)
Time frame: 24 months
Urine albumin:Change in urine albumin
Time frame: 24 months
24 hours mean diastolic BP
Time frame: 24 months
Daytime SBP/DBP
Time frame: 24 months
Night time SBP/DBP
Time frame: 24 months
Dipping Pattern
Time frame: 24 months
24 hour BP variability
Time frame: 24 months
Questionnaire and EQ-5D-5L:Incremental cost per mm Hg BP reduction from baseline to end of follow-up at two years post randomization and incremental cost per projected cardiovascular disease ( CVD) disability adjusted life year (DALY) averted
Time frame: information on healthcare cost will be collected at baseline and 24 months
incremental cost per mm Hg BP reduction from baseline to end of follow-up at 2 years post-randomization and incremental cost per projected CVD disability-adjusted life year (DALY) averted
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Derived from this study: PubMed 34013966Feng L, Jehan I, de Silva HA, Naheed A, Khan AH, Kasturiratne A, Clemens JD, Lim CW, Hughes AD, Chaturvedi N, Jafar TH. Effect of a Multicomponent Intervention on Antihypertensive Medication Intensification in Rural South Asia: Post Hoc Analysis of a Cluster RCT. Am J Hypertens. 2021 Sep 22;34(9):981-988. doi: 10.1093/ajh/hpab072.
- Derived from this study: PubMed 32074419Jafar TH, Gandhi M, de Silva HA, Jehan I, Naheed A, Finkelstein EA, Turner EL, Morisky D, Kasturiratne A, Khan AH, Clemens JD, Ebrahim S, Assam PN, Feng L; COBRA-BPS Study Group. A Community-Based Intervention for Managing Hypertension in Rural South Asia. N Engl J Med. 2020 Feb 20;382(8):717-726. doi: 10.1056/NEJMoa1911965.
- Derived from this study: PubMed 31594895Perera M, de Silva CK, Tavajoh S, Kasturiratne A, Luke NV, Ediriweera DS, Ranasinha CD, Legido-Quigley H, de Silva HA, Jafar TH. Patient perspectives on hypertension management in health system of Sri Lanka: a qualitative study. BMJ Open. 2019 Oct 7;9(10):e031773. doi: 10.1136/bmjopen-2019-031773.
- Derived from this study: PubMed 30486858Gandhi M, Assam PN, Turner EL, Morisky DE, Chan E, Jafar TH; COBRA-BPS Study Group. Statistical analysis plan for the control of blood pressure and risk attenuation-rural Bangladesh, Pakistan, Sri Lanka (COBRA-BPS) trial: a cluster randomized trial for a multicomponent intervention versus usual care in hypertensive patients. Trials. 2018 Nov 29;19(1):658. doi: 10.1186/s13063-018-3022-8.
- Derived from this study: PubMed 29982770Feng L, de Silva HA, Jehan I, Naheed A, Kasturiratne A, Himani G, Hasnat MA, Jafar TH. Regional variation in chronic kidney disease and associated factors in hypertensive individuals in rural South Asia: findings from control of blood pressure and risk attenuation-Bangladesh, Pakistan and Sri Lanka. Nephrol Dial Transplant. 2019 Oct 1;34(10):1723-1730. doi: 10.1093/ndt/gfy184.
- Derived from this study: PubMed 29701801Jafar TH, Gandhi M, Jehan I, Naheed A, de Silva HA, Shahab H, Alam D, Luke N, Wee Lim C; COBRA-BPS Study Group. Determinants of Uncontrolled Hypertension in Rural Communities in South Asia-Bangladesh, Pakistan, and Sri Lanka. Am J Hypertens. 2018 Oct 15;31(11):1205-1214. doi: 10.1093/ajh/hpy071.
- Derived from this study: PubMed 28606184Jafar TH, Jehan I, de Silva HA, Naheed A, Gandhi M, Assam P, Finkelstein EA, Quigley HL, Bilger M, Khan AH, Clemens JD, Ebrahim S, Turner EL; for COBRA-BPS Study Group; Kasturiratne A. Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial. Trials. 2017 Jun 12;18(1):272. doi: 10.1186/s13063-017-2018-0.
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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.
Tazeen H Jafar, MD,MPH principal investigator
Duke-NUS Graduate Medical School
Questions about this trial
What is this clinical trial studying?
A study testing multi-component interventions in people with Hypertension, run by Duke-NUS Graduate Medical School.
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 6 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: status not confirmed, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Blood pressure reading:change in systolic blood pressure (SBP) from baseline to follow-up at 24 months post randomization. (time frame: Blood pressure (BP) will measured at baseline and then at 6-month intervals until 24 months after randomization). 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 NCT02657746, which also lists 7 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 31 Oct 2019.