HypertensionSCALE NCDNCT06740708
Scaling Up Community-based Noncommunicable Disease Research Into Practice in Pokhara Metropolitan City of Nepal
A study testing SCALE-NCD in people with Hypertension and Type 2 Diabetes Mellitus (T2DM), run by Johns Hopkins Bloomberg School of Public Health at 1 site in Nepal.
Trial summary
The goal of this clinical trial is to evaluate whether a multifaceted community-based intervention, comprising 1) screening and lifestyle counseling by female community health volunteers (FCHVs); community health workers in Nepal, through home visits, and 2) regular Short Message Service (SMS) messages, can… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hypertension, Type 2 Diabetes Mellitus (T2DM), Tobacco Smoking
- What is being tested?
- SCALE-NCD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- 1 siteNepal
- Study dates
- 28 Apr 2025to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting at least one of the following three conditions
- Hypertensive, defined as
- BP≥140/90 mmHg at two separate measurements
- Type 2 diabetes, defined as
- Fingerprick glucose≥100 mg/dL, and plasma fasting glucose ≥126 mg/dL, and HbA1c≥6.5
- Current smoker, defined as
Show all 10Show fewer
- Ever smoked ≥100 cigarettes in lifetime, and
- Currently smokes every day.
- Registered on the voter list in Pokhara.
- Not planning to migrate outside of Pokhara during the study period
Who cannot join
- Blood pressure ≥180/120 mmHg or
- Blood glucose >250 mg/dL or <54 mg/dL
- Diagnosed with secondary hypertension by health professionals
- Diagnosed with other diabetes besides type 2 by health professionals
- Presenting with acute symptoms that may require hospitalizations, which includes but not limited to:
- Nausea, vomiting, diarrhea
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- Abdominal pain
- Polyuria, polydipsia, polyphagia
- Loss of motor or sensory function
- Altered mental status.
- Chest pain, chest tightness
- Dyspnea, shortness of breath
- Fever
- Diagnosed as terminally ill by a health professional, defined as life expectancy of 6 months or less.
- Pregnant or intend to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate whether a multifaceted community-based intervention, comprising 1) screening and lifestyle counseling by female community health volunteers (FCHVs); community health workers in Nepal, through home visits, and 2) regular Short Message Service (SMS) messages, can effectively reduce systolic blood pressure (SBP), lower fasting blood glucose, and increase smoking cessation rates among adults living in Pokhara with hypertension, type 2 diabetes, and smoking habits, respectively.
The main research questions are:
Read more
- Can FCHV home visits combined with regular mobile phone messages focused on blood pressure management reduce systolic blood pressure in adults with hypertension?
- Can FCHV home visits combined with regular mobile phone messages focused on diabetes management lower fasting blood glucose levels in adults with type 2 diabetes?
- Can FCHV home visits combined with regular mobile phone messages focused on smoking cessation increase the cessation rate among current smokers?
Researchers will compare the intervention group with a usual care group, which does not receive regular FCHV home visits for managing the three aforementioned risk factors or mobile phone messages.
Read the detailed description
Background: Rapid globalization and urbanization continue to escalate the burden of non-communicable diseases (NCDs) across the world, disproportionally affecting low- and middle-income countries (LMICs). To date, trials have documented that task-sharing with community health workers (CHWs) can reduce systolic blood pressure and fasting blood glucose and achieve smoking cessation. However, most trials have been done in rural settings, and only focused on managing a single condition, such as hypertension. Furthermore, despite increasing evidence of the effectiveness from clinical trials, there is a lack of studies exploring best practices for 'how' to implement and sustain these interventions in LMICs.
Study Design: Type 2 hybrid effectiveness-implementation research study containing 1) a qualitative study, 2) open-label, two-armed, cluster randomized controlled trial (cRCT), and 3) implementation research plan. The details of the c-RCT only are presented below.
Settings: Pokhara Metropolitan City of Nepal. Pokhara is the second largest city in Nepal containing 33 administrative units called "wards". The investigators consider wards as clusters and randomize these 30 clusters (28 independent wards and 2 combined wards) into intervention and control groups in a 1:1 ratio.
Participants: Adults with ages between 40-75 having at least one of the following conditions:
- Hypertension, defined as:
- BP≥140/90 mmHg at two separate measures, or ii. Under pharmacotherapy for hypertension
- Type 2 diabetes mellitus, defined as i. Fingerprick glucose (fasting) ≥100 mg/dl, plasma glucose (fasting) ≥126 mg/dL, and ii. HbA1c ≥ 6.5 %, or iii. Under pharmacotherapies for type 2 diabetes
- Current tobacco smoking, defined as i. Ever smoked ≥100 cigarettes in lifetime, and ii. Currently smokes every day or on some days.
Intervention: Multifaceted intervention containing the following two components:
- FCHV home visits every three months
- Mobile phone messages, including
Control: Usual care in Pokhara Metropolitan City in Nepal, which does not include FCHV home visits for management of hypertension, diabetes, or smoking, and mobile phone messages.
Outcome: Changes in systolic blood pressure, fasting blood glucose, and smoking cessation at 6 months post randomization will be measured as primary outcomes.
- Being tested
- SCALE-NCD
- Keywords
- hypertension, type 2 diabetes mellitus, tobacco smoking, task-sharing, task-shifting, community health workers, female community health volunteers
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCALE-NCDBehavioural
- FCHV home visits every three months, including
- For hypertension i. Blood pressure measurement with digital BP devices ii. Lifestyle counseling iii. Referral if uncontrolled BP (≥140/90 mmHg) for 3 months
- For type 2 diabetes i. Fasting blood glucose measurement with glucometer ii. Lifestyle counseling focusing on diabetes management iii. Referral if uncontrolled diabetes (≥126mg/dl) for 3 months
- For current smokers i. Smoking cessation counseling ii. Referral for nicotine replacement therapy if request by participants
- Mobile phone messages, including
- Lifestyle modification
- Conveyed as voice or text messages, depending on participant preference
| Study group | Role | What they receive |
|---|---|---|
| SCALE-NCD (Intervention) | Experimental | Intervention arm will receive the following two components of the SCALE-NCD intervention package:
1. FCHV home visits every three months, including measurements, counseling and referral;
2. Mobile phone messages, including lifestyle modification Receives: Behavioral: SCALE-NCD |
| Control | No intervention | Control arm will receive the usual care in Pokhara Metropolitan City in Nepal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure (mmHg)
Difference in systolic blood pressure change between the intervention and the control groups among participants enrolled as having hypertension.
Measured: 6 months post randomization
Fasting Plasma glucose
Difference in fasting plasma glucose change between the intervention and the control groups among participants enrolled as having type 2 diabetes.
Measured: 6 months post randomization
Participants Who Have Achieved Smoking cessation
Participants who have not smoked for the past 30 days between the intervention and the control groups, among participants enrolled as current smokers.
Measured: 6 months post randomization
Secondary outcomes (16)
Diastolic blood pressure (mmHg)
Difference in diastolic blood pressure change between the intervention and the control groups among participants enrolled as having hypertension.
Measured: 6 months post randomization
Controlled blood pressure control (<140/90 mmHg) rate
Difference in the proportion of those with BP<140/90 mmHg between the intervention and the control groups, among participants enrolled as having hypertension.
Measured: 6 months post randomization
Mean HbA1c level
Difference in mean HbA1c between the intervention and the control groups, among participants enrolled as having type 2 diabetes.
Measured: 6 months post randomization
Mean Weight in Kg
Difference in mean weight between the intervention and the control groups, among participants enrolled as having type 2 diabetes.
Measured: 6 months post randomization
Mean Total Cholesterol (mg/dL)
Difference in mean total cholesterol levels between the intervention and the control groups, among participants with high total cholesterol (≥ 200 mg/dL) at baseline.
Measured: 6 months post randomization
Mean HDL (mg/dL)
Difference in mean HDL levels between the intervention and the control groups, among participants with low HDL (< 40 mg/dL) at baseline.
Measured: 6 months post randomization
Mean LDL level (mg/dL)
Difference in mean LDL levels between the intervention and the control groups, among participants with high LDL (≥ 100 mg/dL) at baseline.
Measured: 6 months post randomization
Mean Triglyceride Levels (mg/dL)
Difference in mean triglyceride levels between the intervention and the control groups, among participants with high triglyceride level (≥ 150 mg/dL) at baseline.
Measured: 6 months post randomization
Medication adherence, antihypertensive medicines
Difference in the proportion of those not missing a single anti-hypertensive pill over the past 1 week between the intervention and the control groups, among participants enrolled as having hypertension.
Measured: 6 months post randomization
Medication adherence, hypoglycemic medicines
Difference in the proportion of those not missing a single hypoglycemic pill or injection over the past 1 week between the intervention and the control groups, among participants enrolled as having type 2 diabetes.
Measured: 6 months post randomization
Fagerstrom Test for Nicotine Dependence (FTND) score
Difference in the proportion of those with a high FTND score (5-10) between the intervention and the control groups, among participants enrolled as current smokers. Higher means more dependence on nicotine.
Measured: 6 months post randomization
Smoking cessation, 7 days
Difference in the proportion of those who have not smoked for the past 7 days between the intervention and the control groups, among participants enrolled as current smokers.
Measured: 6 months post randomization
Harmful alcohol consumption rate, self-report
Difference in the proportion of those taking 7 (if women) and 14 (if men) standard drinks over the past 1 week between the intervention and the control groups, among all participants.
Measured: 6 months post randomization
Low dietary salt intake rate, self-report
Difference in the proportion of those taking 5 mg or less salt per day between the intervention and the control groups, among participants enrolled as having hypertension.
Measured: 6 months post randomization
High physical activity rate, self-report
Difference in the proportion of those who had 3000 metabolic equivalents of tasks (MET) or more per week between the intervention and control groups, among participants enrolled as having hypertension and/or diabetes.
Measured: 6 months post randomization
High fruit and vegetable intake rate, self-report
Difference in the proportion of those who consumed 5 or more servings of fruits and/or vegetables per day between the intervention and control groups, among participants enrolled as having hypertension and/or diabetes.
Measured: 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start28 Apr 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Dinesh Neupane, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740708
- Sponsor's protocol ID
- IRB00030203
- Other IDs
- R01HL172271
- Acronym
- SCALE NCD
- Status last verified
- Jun 2026
- First submitted
- 13 Dec 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Inagaki Y, Koirala S, Khan MH, Ghimire K, Soti PB, Bhattarai N, Bhandari P, Pathiravasan CH, Bhandari B, Thapa R, Khadka KB, Yao Z, Shrestha A, Garcia-Larsen V, Finkelstein EA, Moore JB, Closser S, Appel LJ, Kallestrup P, Neupane D. Scaling up community-based non-communicable disease research into practice in Pokhara Metropolitan City of Nepal (SCALE-NCD) trial: study protocol for a cluster-randomized controlled trial. Trials. 2026 Jul 3. doi: 10.1186/s13063-026-09842-w. Online ahead of print.
PubMed 42400007Inagaki Y, Koirala S, Khan MH, Ghimire K, Soti PB, Bhattarai N, Bhandari P, Pathiravasan CH, Bhandari B, Thapa R, Khadka KB, Yao Z, Shrestha A, Garcia-Larsen V, Finkelstein EA, Moore JB, Closser S, Appel LJ, Kallestrup P, Neupane D. Scaling Up Community-based Noncommunicable Disease Research into Practice in Pokhara Metropolitan City of Nepal (SCALE-NCD) trial: study protocol for a cluster-randomized controlled trial. Res Sq [Preprint]. 2026 May 25:rs.3.rs-8320113. doi: 10.21203/rs.3.rs-8320113/v1.
PubMed 42245813
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling Up Community-based Noncommunicable Disease Research Into Practice in Pokhara Metropolitan City of Nepal
- ClinicalTrials.gov ID
- NCT06740708
- Acronym / sponsor ID
- SCALE NCD / IRB00030203
- Keywords
- hypertension, type 2 diabetes mellitus, tobacco smoking, task-sharing, task-shifting, community health workers, female community health volunteers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,100 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 18 Dec 2024 (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 goal of this clinical trial is to evaluate whether a multifaceted community-based intervention, comprising 1) screening and lifestyle counseling by female community health volunteers (FCHVs); community health workers in Nepal, through home visits, and 2) regular Short Message Service (SMS) messages, can effectively reduce systolic blood pressure (SBP), lower fasting blood glucose, and increase smoking cessation rates among adults living in Pokhara with hypertension, type 2 diabetes, and smoking habits, respectively.
The main research questions are:
- Can FCHV home visits combined with regular mobile phone messages focused on blood pressure management reduce systolic blood pressure in adults with hypertension?
- Can FCHV home visits combined with regular mobile phone messages focused on diabetes management lower fasting blood glucose levels in adults with type 2 diabetes?
- Can FCHV home visits combined with regular mobile phone messages focused on smoking cessation increase the cessation rate among current smokers?
Researchers will compare the intervention group with a usual care group, which does not receive regular FCHV home visits for managing the three aforementioned risk factors or mobile phone messages.
Detailed description
Background: Rapid globalization and urbanization continue to escalate the burden of non-communicable diseases (NCDs) across the world, disproportionally affecting low- and middle-income countries (LMICs). To date, trials have documented that task-sharing with community health workers (CHWs) can reduce systolic blood pressure and fasting blood glucose and achieve smoking cessation. However, most trials have been done in rural settings, and only focused on managing a single condition, such as hypertension. Furthermore, despite increasing evidence of the effectiveness from clinical trials, there is a lack of studies exploring best practices for 'how' to implement and sustain these interventions in LMICs.
Study Design: Type 2 hybrid effectiveness-implementation research study containing 1) a qualitative study, 2) open-label, two-armed, cluster randomized controlled trial (cRCT), and 3) implementation research plan. The details of the c-RCT only are presented below.
Settings: Pokhara Metropolitan City of Nepal. Pokhara is the second largest city in Nepal containing 33 administrative units called "wards". The investigators consider wards as clusters and randomize these 30 clusters (28 independent wards and 2 combined wards) into intervention and control groups in a 1:1 ratio.
Participants: Adults with ages between 40-75 having at least one of the following conditions:
- Hypertension, defined as:
- BP≥140/90 mmHg at two separate measures, or ii. Under pharmacotherapy for hypertension
- Type 2 diabetes mellitus, defined as i. Fingerprick glucose (fasting) ≥100 mg/dl, plasma glucose (fasting) ≥126 mg/dL, and ii. HbA1c ≥ 6.5 %, or iii. Under pharmacotherapies for type 2 diabetes
- Current tobacco smoking, defined as i. Ever smoked ≥100 cigarettes in lifetime, and ii. Currently smokes every day or on some days.
Intervention: Multifaceted intervention containing the following two components:
- FCHV home visits every three months
- Mobile phone messages, including
Control: Usual care in Pokhara Metropolitan City in Nepal, which does not include FCHV home visits for management of hypertension, diabetes, or smoking, and mobile phone messages.
Outcome: Changes in systolic blood pressure, fasting blood glucose, and smoking cessation at 6 months post randomization will be measured as primary outcomes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCALE-NCD (Intervention) | Experimental | Behavioral: SCALE-NCDIntervention arm will receive the following two components of the SCALE-NCD intervention package: 1. FCHV home visits every three months, including measurements, counseling and referral; 2. Mobile phone messages, including lifestyle modification |
| Control | No intervention | –Control arm will receive the usual care in Pokhara Metropolitan City in Nepal. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Meeting at least one of the following three conditions
- Registered on the voter list in Pokhara.
- Not planning to migrate outside of Pokhara during the study period
Key exclusion criteria (15 listed)
- Blood pressure ≥180/120 mmHg or
- Blood glucose >250 mg/dL or <54 mg/dL
- Diagnosed with secondary hypertension by health professionals
- Diagnosed with other diabetes besides type 2 by health professionals
- Presenting with acute symptoms that may require hospitalizations, which includes but not limited to:
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 |
|---|---|---|
| SCALE-NCD1. FCHV home visits every three months, including * For hypertension i. Blood pressure measurement with digital BP devices ii. Lifestyle counseling iii. Referral if uncontrolled BP (≥140/90 mmHg) for 3 months * For type 2 diabetes i. Fasting blood glucose measurement with glucometer ii. Lifestyle counseling focusing on diabetes management iii. Referral if uncontrolled diabetes (≥126mg/dl) for 3 months * For current smokers i. Smoking cessation counseling ii. Referral for nicotine replacement therapy if request by participants 2. Mobile phone messages, including * Lifestyle modification * Conveyed as voice or text messages, depending on participant preference | Behavioural | SCALE-NCD (Intervention) |
Primary outcome
Systolic blood pressure (mmHg)
Time frame: 6 months post randomization
Difference in systolic blood pressure change between the intervention and the control groups among participants enrolled as having hypertension.
Fasting Plasma glucose
Time frame: 6 months post randomization
Difference in fasting plasma glucose change between the intervention and the control groups among participants enrolled as having type 2 diabetes.
Participants Who Have Achieved Smoking cessation
Time frame: 6 months post randomization
Participants who have not smoked for the past 30 days between the intervention and the control groups, among participants enrolled as current smokers.
16 secondary outcomes
Diastolic blood pressure (mmHg)
Time frame: 6 months post randomization
Controlled blood pressure control (<140/90 mmHg) rate
Time frame: 6 months post randomization
Mean HbA1c level
Time frame: 6 months post randomization
Mean Weight in Kg
Time frame: 6 months post randomization
Mean Total Cholesterol (mg/dL)
Time frame: 6 months post randomization
Mean HDL (mg/dL)
Time frame: 6 months post randomization
Mean LDL level (mg/dL)
Time frame: 6 months post randomization
Mean Triglyceride Levels (mg/dL)
Time frame: 6 months post randomization
Medication adherence, antihypertensive medicines
Time frame: 6 months post randomization
Medication adherence, hypoglycemic medicines
Time frame: 6 months post randomization
Fagerstrom Test for Nicotine Dependence (FTND) score
Time frame: 6 months post randomization
Smoking cessation, 7 days
Time frame: 6 months post randomization
Harmful alcohol consumption rate, self-report
Time frame: 6 months post randomization
Low dietary salt intake rate, self-report
Time frame: 6 months post randomization
High physical activity rate, self-report
Time frame: 6 months post randomization
High fruit and vegetable intake rate, self-report
Time frame: 6 months post randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Derived from this study: PubMed 42400007Inagaki Y, Koirala S, Khan MH, Ghimire K, Soti PB, Bhattarai N, Bhandari P, Pathiravasan CH, Bhandari B, Thapa R, Khadka KB, Yao Z, Shrestha A, Garcia-Larsen V, Finkelstein EA, Moore JB, Closser S, Appel LJ, Kallestrup P, Neupane D. Scaling up community-based non-communicable disease research into practice in Pokhara Metropolitan City of Nepal (SCALE-NCD) trial: study protocol for a cluster-randomized controlled trial. Trials. 2026 Jul 3. doi: 10.1186/s13063-026-09842-w. Online ahead of print.
- Derived from this study: PubMed 42245813Inagaki Y, Koirala S, Khan MH, Ghimire K, Soti PB, Bhattarai N, Bhandari P, Pathiravasan CH, Bhandari B, Thapa R, Khadka KB, Yao Z, Shrestha A, Garcia-Larsen V, Finkelstein EA, Moore JB, Closser S, Appel LJ, Kallestrup P, Neupane D. Scaling Up Community-based Noncommunicable Disease Research into Practice in Pokhara Metropolitan City of Nepal (SCALE-NCD) trial: study protocol for a cluster-randomized controlled trial. Res Sq [Preprint]. 2026 May 25:rs.3.rs-8320113. doi: 10.21203/rs.3.rs-8320113/v1.
- Individual participant dataSharing planned: No
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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.
Dinesh Neupane, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCALE-NCD in people with Hypertension and Type 2 Diabetes Mellitus (T2DM), run by Johns Hopkins Bloomberg School of Public Health at 1 site in Nepal.
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 10 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. 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 Nepal. 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?
This study is still under way. Results are not available in the source record yet.
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?
Systolic blood pressure (mmHg) (time frame: 6 months post randomization). The study lists 3 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 NCT06740708, which also lists 2 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 15 Jun 2026.