Hypertension (HTN)BASIC-SNCT07755631
The BASIC-S Feasibility Study for Vascular Risk Reduction
A study testing BASIC-S Intervention in people with Hypertension (HTN) and Vascular Diseases, run by Andrew Appleton at 1 site in Canada.
Trial summary
Vascular risk factors drive stroke, heart disease, and dementia, but translating lifestyle guidelines into routine clinical care remains challenging. To address this, we developed BASIC-S (Blood Pressure, Activity, Sleep, Interaction, Consumption, and Support), a framework targeting Blood pressure, Activity, Sleep… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension (HTN), Vascular Diseases, Stroke
- What is being tested?
- BASIC-S Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2026to 1 Oct 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older currently employed at or recently retired from the London Health Sciences Centre (LHSC) or Western University (with an operational focus on pre-retirees aged 50 years and older).
- The primary applicant (not their partner, if applicable) must be within two years before or after their retirement date.
- Spouse or cohabitating partner of an enrolled primary participant. Cohabitating partners may include a common-law partner, adult child, close friend, or roommate who lives with the primary participant and shares common health goals. Enrollment of partners is optional but strongly encouraged.
- Capable of providing informed consent.
- Has access to a mobile device capable of receiving Short Message Service (SMS) communications and viewing Portable Document Format (PDF) documents.
- Physically able to safely engage in light-to-moderate intensity physical activity.
Who cannot join
- Medical conditions that preclude safe participation in physical activity (for instance, unstable angina, uncontrolled arrhythmia, severe heart failure) without physician clearance.
- Active or unstable psychiatric illness, defined as hospitalization for psychiatric care within the preceding 6 months or modifications to antipsychotic or mood-stabilizing pharmacotherapy within the preceding 3 months. Participants with stable, medically managed psychiatric conditions remain eligible.
- Severe cognitive impairment that compromises the ability to provide informed consent or independently use study-related technology.
- Inability to read and understand English sufficiently to provide informed consent and complete study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abolfazl Avan, MD, PhD. contact
Canada1 site
London Health Sciences Centre (LHSC)
London, Ontario, N6A 3K7
519-685-8500 ext. 33071, andrew.appleton@lhsc.on.ca
Andrew J Appleton, MD.
About this study
Official title: Piloting an Integrated Lifestyle Intervention for Vascular Risk Reduction: The BASIC-S Feasibility Study
Vascular risk factors drive stroke, heart disease, and dementia, but translating lifestyle guidelines into routine clinical care remains challenging. To address this, we developed BASIC-S (Blood Pressure, Activity, Sleep, Interaction, Consumption, and Support), a framework targeting Blood pressure, Activity, Sleep, Interaction (socially), Consumption (nutrition), and Support using partner support and motivational interviewing. This individual-focused approach bypasses the logistical and financial barriers of complex clinical interventions by using sustained behavioral science to support gradual lifestyle changes. This study is a single-center, mixed-methods, cluster-randomized pilot trial evaluating the feasibility of the BASIC-S protocol in an occupational setting. A maximum of 60 households (120 participants) will be randomized 1:1 to either the BASIC-S intervention (motivational coaching, secure video check-ins, automated text messages, and a digital workbook) or standard care. Outcomes will assess feasibility, acceptability, and the validity of new tracking metrics to inform a future full-scale trial.
Read the detailed description
Background and Rationale:
High blood pressure, inactivity, poor sleep, social isolation, and unhealthy diets drive stroke, heart disease, and dementia. As dementia rates plateau and cardiovascular diseases rise, current public health strategies are stalling. The 2025 Hypertension Canada guidelines lowered the threshold for hypertension to 130/80 mm Hg (target <130 mm Hg), vastly increasing the population needing management. However, translating lifestyle risk reduction into routine care is hindered by fragmented clinical workflows and a lack of behavioral support.
To address this, we developed BASIC-S (Blood Pressure, Activity, Sleep, Interaction, Consumption, and Support) framework. Grounded in partnering and motivational interviewing principles, BASIC-S is designed to bridge the evidence-to-practice implementation gap and support the translation of research into real-world health behavior change.
Study Design and Setting:
This study is a single-center, mixed-methods, cluster-randomized pilot trial conducted at the London Health Sciences Centre (LHSC). Randomization occurs at the household level, enrolling either individual employees or employee-partner pairs. Households are randomized 1:1 to either the BASIC-S intervention or standard care for six months.
Statistical Analysis Plan:
Analyses will be conducted at the individual participant level, with the primary timepoint for comparison being 6 months. To account for the potential clustering effects of households, continuous outcome data will be analyzed using mixed models for repeated measures, incorporating a random intercept for the household. Sensitivity to the normality assumptions of continuous outcomes will be assessed using rank-based methods designed for cluster-randomized trials. Discrete outcomes will be evaluated using a generalized estimating equations (GEE) approach alongside applicable rank-based methods. The standard deviation of the change scores and the intraclass correlation coefficient (ICC) will be estimated to inform power calculations for the future definitive trial. To assess convergent validity, correlation coefficients (e.g., Pearson or Spearman) will be calculated between the novel indices and established psychometric reference scales. Qualitative transcripts will undergo thematic analysis by two independent coders to systematically classify barriers, facilitators, and overall acceptability.
- Conditions
- Hypertension (HTN), Vascular Diseases, Stroke, Dementia, Cardiovascular Risk Factor, Cognitive Decline
- Being tested
- BASIC-S Intervention, Standard / Usual Care
- Keywords
- Lifestyle Intervention, Motivational Interviewing, Primary Prevention, Behavioral Medicine, Brain Health, Cognition, Mental Health, Social Activity, Social Isolation, Physical Activity, Blood Pressure, Activity, Sleep, Interaction, Consumption, Support, Partnering
- Medical subject headings
- Hypertension, Vascular Diseases, Stroke, Dementia, Cognitive Dysfunction, Psychological Well-Being, Social Isolation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASIC-S InterventionBehavioural
Participants attend an initial 45-minute goal-setting session with a certified wellness coach. Subsequent support includes an interactive BASIC-S Digital Workbook, automated twice-weekly motivational and educational SMS messages via Twilio, and biweekly (every two weeks) 15-20 minute face-to-face secure video booster sessions (via Microsoft Teams) using motivational interviewing. Intervention households receive a validated automated home blood pressure monitor at baseline.
Standard / Usual CareBehavioural
Also called Waitlist, Control
Participants are instructed to continue routine medical follow-up as directed by their primary care providers. To serve as a true comparator, no study-specific behavioral prompts or educational materials are provided during the active 6-month study period. To maximize ethical benefit (waitlist control), control households receive the complete BASIC-S Digital Workbook and a validated automated home blood pressure monitor at the conclusion of their 6-month follow-up visit.
| Study group | Role | What they receive |
|---|---|---|
| BASIC-S Intervention Group | Experimental | Households allocated to this arm receive a multicomponent behavioral lifestyle program grounded in the Information-Motivation-Behavioral Skills (IMB) model. Receives: Behavioral: BASIC-S Intervention |
| Standard Care (Usual Care) Group | Active comparator | Households allocated to this arm receive pure usual care to serve as a real-world comparator, continuing their routine healthcare and access to institutional wellness resources. Receives: Behavioral: Standard / Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Feasibility operationalized as the proportion of eligible individuals approached who consent to enroll in the trial.
Measured: At the conclusion of the 5-month recruitment period.
Retention Rate
Feasibility operationalized as the proportion of enrolled participants who complete the final 6-month follow-up assessment.
Measured: At 6 months post-randomization.
Secondary outcomes (9)
Change in Integral Brain Health (IBH) Index Score
A 3-item self-report scale assessing perceived cognition, mood, and social connection. Each item is scored 1-5. Total scores range from 3 to 15, with higher scores indicating better self-perceived brain health.
Measured: Baseline, 3 Months, 6 Months.
Change in BASIC-S Implementation Index Score
A 5-domain self-report scale quantifying adherence to core lifestyle domains (Blood pressure, Activity, Sleep, Interaction, and Consumption). Scored using a hierarchically weighted system based on goal attainment (0.0 to 3.0 points per domain). Total score ranges from 0 to 15, with higher scores indicating greater lifestyle adherence. Support serves as a distinct implementation enhancer (scored separately from 0.0 to 3.0).
Measured: Baseline, 3 Months, 6 Months.
Change in Systolic Blood Pressure
Measured using a standardized automated oscillometric device (average of 3 readings after a 5-minute seated rest). The unit of measure is millimeters of mercury (mmHg).
Measured: Baseline, 3 Months, 6 Months.
Change in Subjective Well-Being (WHO-5)
Measured using the World Health Organization-5 (WHO-5) Well-Being Index. The scale contains 5 items, each scored from 0 to 5. Total raw scores range from 0 to 25 and are multiplied by 4 to generate a percentage score (0-100), with higher scores representing better well-being.
Measured: Baseline and 6 Months.
Change in Subjective Cognitive Function (PROMIS)
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form 4a. Raw scores range from 4 to 20, which are translated into standardized T-scores. Higher scores indicate better cognitive function.
Measured: Baseline and 6 Months
Change in Sleep Disturbance (PROMIS)
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 4a. Raw scores range from 4 to 20, translated into standardized T-scores. Higher scores indicate greater sleep disturbance.
Measured: Baseline and 6 Months
Change in Physical Activity (PAVS)
Measured using the Physical Activity Vital Sign (PAVS). Calculated by multiplying the reported days of physical activity per week by the reported minutes per day, yielding a total of moderate-to-vigorous physical activity minutes per week.
Measured: Baseline and 6 Months
Change in Social Connectivity (LSNS-6)
Measured using the Lubben Social Network Scale-6 (LSNS-6). Contains 6 items scored from 0 to 5. Total scores range from 0 to 30, with higher scores indicating stronger social networks and lower risk of isolation.
Measured: Baseline and 6 Months
Change in Dietary Quality (STC)
Measured using the 8-item Starting The Conversation (STC) Dietary Tool. Total scores range from 0 to 16, with higher scores indicating poorer dietary quality (greater consumption of unhealthy foods).
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 posted10 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
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 Hypertension (HTN)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew Appleton
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario
- Responsible party
- Sponsor-investigator, Andrew Appleton, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755631
- Sponsor's protocol ID
- 16919
- Other IDs
- INN26-004
- Acronym
- BASIC-S
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) collected during the trial will be made available to qualified researchers who provide a methodologically sound proposal to achieve aims outlined in the approved proposal.
Publications
Avan A, Hachinski V. Global, regional, and national trends of dementia incidence and risk factors, 1990-2019: A Global Burden of Disease study. Alzheimers Dement. 2023 Apr;19(4):1281-1291. doi: 10.1002/alz.12764. Epub 2022 Aug 31.
PubMed 36044376Hachinski V. Brain Health-Curbing Stroke, Heart Disease, and Dementia: The 2020 Wartenberg Lecture. Neurology. 2021 Aug 10;97(6):273-279. doi: 10.1212/WNL.0000000000012103. Epub 2021 Apr 21.
PubMed 33883239Avan A, Andersen R, Andersson N, Frisbee SJ, Singh S, Zhong S, Rogers KA, Whitehead SN, Hachinski V. An operational measurement of brain health: the ABCDS framework. Lancet Neurol. 2025 Apr;24(4):291-292. doi: 10.1016/S1474-4422(25)00076-6. No abstract available.
PubMed 40120612
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting an Integrated Lifestyle Intervention for Vascular Risk Reduction: The BASIC-S Feasibility Study
- ClinicalTrials.gov ID
- NCT07755631
- Acronym / sponsor ID
- BASIC-S / 16919
- Conditions
- Hypertension (HTN), Vascular Diseases, Stroke, Dementia, Cardiovascular Risk Factor, Cognitive Decline
- Keywords
- Lifestyle Intervention, Motivational Interviewing, Primary Prevention, Behavioral Medicine, Brain Health, Cognition, Mental Health, Social Activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Andrew AppletonUniversity, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 10 Aug 2026 (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.
Vascular risk factors drive stroke, heart disease, and dementia, but translating lifestyle guidelines into routine clinical care remains challenging. To address this, we developed BASIC-S (Blood Pressure, Activity, Sleep, Interaction, Consumption, and Support), a framework targeting Blood pressure, Activity, Sleep, Interaction (socially), Consumption (nutrition), and Support using partner support and motivational interviewing. This individual-focused approach bypasses the logistical and financial barriers of complex clinical interventions by using sustained behavioral science to support gradual lifestyle changes. This study is a single-center, mixed-methods, cluster-randomized pilot trial evaluating the feasibility of the BASIC-S protocol in an occupational setting. A maximum of 60 households (120 participants) will be randomized 1:1 to either the BASIC-S intervention (motivational coaching, secure video check-ins, automated text messages, and a digital workbook) or standard care. Outcomes will assess feasibility, acceptability, and the validity of new tracking metrics to inform a future full-scale trial.
Detailed description
Background and Rationale:
High blood pressure, inactivity, poor sleep, social isolation, and unhealthy diets drive stroke, heart disease, and dementia. As dementia rates plateau and cardiovascular diseases rise, current public health strategies are stalling. The 2025 Hypertension Canada guidelines lowered the threshold for hypertension to 130/80 mm Hg (target <130 mm Hg), vastly increasing the population needing management. However, translating lifestyle risk reduction into routine care is hindered by fragmented clinical workflows and a lack of behavioral support.
To address this, we developed BASIC-S (Blood Pressure, Activity, Sleep, Interaction, Consumption, and Support) framework. Grounded in partnering and motivational interviewing principles, BASIC-S is designed to bridge the evidence-to-practice implementation gap and support the translation of research into real-world health behavior change.
Study Design and Setting:
This study is a single-center, mixed-methods, cluster-randomized pilot trial conducted at the London Health Sciences Centre (LHSC). Randomization occurs at the household level, enrolling either individual employees or employee-partner pairs. Households are randomized 1:1 to either the BASIC-S intervention or standard care for six months.
Statistical Analysis Plan:
Analyses will be conducted at the individual participant level, with the primary timepoint for comparison being 6 months. To account for the potential clustering effects of households, continuous outcome data will be analyzed using mixed models for repeated measures, incorporating a random intercept for the household. Sensitivity to the normality assumptions of continuous outcomes will be assessed using rank-based methods designed for cluster-randomized trials. Discrete outcomes will be evaluated using a generalized estimating equations (GEE) approach alongside applicable rank-based methods. The standard deviation of the change scores and the intraclass correlation coefficient (ICC) will be estimated to inform power calculations for the future definitive trial. To assess convergent validity, correlation coefficients (e.g., Pearson or Spearman) will be calculated between the novel indices and established psychometric reference scales. Qualitative transcripts will undergo thematic analysis by two independent coders to systematically classify barriers, facilitators, and overall acceptability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BASIC-S Intervention Group | Experimental | Behavioral: BASIC-S InterventionHouseholds allocated to this arm receive a multicomponent behavioral lifestyle program grounded in the Information-Motivation-Behavioral Skills (IMB) model. |
| Standard Care (Usual Care) Group | Active comparator | Behavioral: Standard / Usual CareHouseholds allocated to this arm receive pure usual care to serve as a real-world comparator, continuing their routine healthcare and access to institutional wellness resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years and older currently employed at or recently retired from the London Health Sciences Centre (LHSC) or Western University (with an operational focus on pre-retirees aged 50 years and older).
- The primary applicant (not their partner, if applicable) must be within two years before or after their retirement date.
- Spouse or cohabitating partner of an enrolled primary participant. Cohabitating partners may include a common-law partner, adult child, close friend, or roommate who lives with the primary participant and shares common health goals. Enrollment of partners is optional but strongly encouraged.
- Capable of providing informed consent.
- Has access to a mobile device capable of receiving Short Message Service (SMS) communications and viewing Portable Document Format (PDF) documents.
Key exclusion criteria (4 listed)
- Medical conditions that preclude safe participation in physical activity (for instance, unstable angina, uncontrolled arrhythmia, severe heart failure) without physician clearance.
- Active or unstable psychiatric illness, defined as hospitalization for psychiatric care within the preceding 6 months or modifications to antipsychotic or mood-stabilizing pharmacotherapy within the preceding 3 months. Participants with stable, medically managed psychiatric conditions remain eligible.
- Severe cognitive impairment that compromises the ability to provide informed consent or independently use study-related technology.
- Inability to read and understand English sufficiently to provide informed consent and complete study procedures.
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 |
|---|---|---|
| BASIC-S InterventionParticipants attend an initial 45-minute goal-setting session with a certified wellness coach. Subsequent support includes an interactive BASIC-S Digital Workbook, automated twice-weekly motivational and educational SMS messages via Twilio, and biweekly (every two weeks) 15-20 minute face-to-face secure video booster sessions (via Microsoft Teams) using motivational interviewing. Intervention households receive a validated automated home blood pressure monitor at baseline. | Behavioural | BASIC-S Intervention Group |
| Standard / Usual CareAlso: Waitlist, ControlParticipants are instructed to continue routine medical follow-up as directed by their primary care providers. To serve as a true comparator, no study-specific behavioral prompts or educational materials are provided during the active 6-month study period. To maximize ethical benefit (waitlist control), control households receive the complete BASIC-S Digital Workbook and a validated automated home blood pressure monitor at the conclusion of their 6-month follow-up visit. | Behavioural | Standard Care (Usual Care) Group |
Primary outcome
Recruitment Rate
Time frame: At the conclusion of the 5-month recruitment period.
Feasibility operationalized as the proportion of eligible individuals approached who consent to enroll in the trial.
Retention Rate
Time frame: At 6 months post-randomization.
Feasibility operationalized as the proportion of enrolled participants who complete the final 6-month follow-up assessment.
9 secondary outcomes
Change in Integral Brain Health (IBH) Index Score
Time frame: Baseline, 3 Months, 6 Months.
Change in BASIC-S Implementation Index Score
Time frame: Baseline, 3 Months, 6 Months.
Change in Systolic Blood Pressure
Time frame: Baseline, 3 Months, 6 Months.
Change in Subjective Well-Being (WHO-5)
Time frame: Baseline and 6 Months.
Change in Subjective Cognitive Function (PROMIS)
Time frame: Baseline and 6 Months
Change in Sleep Disturbance (PROMIS)
Time frame: Baseline and 6 Months
Change in Physical Activity (PAVS)
Time frame: Baseline and 6 Months
Change in Social Connectivity (LSNS-6)
Time frame: Baseline and 6 Months
Change in Dietary Quality (STC)
Time frame: Baseline and 6 Months
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 25 Aug 2026.
- Background: PubMed 36044376Avan A, Hachinski V. Global, regional, and national trends of dementia incidence and risk factors, 1990-2019: A Global Burden of Disease study. Alzheimers Dement. 2023 Apr;19(4):1281-1291. doi: 10.1002/alz.12764. Epub 2022 Aug 31.
- Background: PubMed 33883239Hachinski V. Brain Health-Curbing Stroke, Heart Disease, and Dementia: The 2020 Wartenberg Lecture. Neurology. 2021 Aug 10;97(6):273-279. doi: 10.1212/WNL.0000000000012103. Epub 2021 Apr 21.
- Background: PubMed 40120612Avan A, Andersen R, Andersson N, Frisbee SJ, Singh S, Zhong S, Rogers KA, Whitehead SN, Hachinski V. An operational measurement of brain health: the ABCDS framework. Lancet Neurol. 2025 Apr;24(4):291-292. doi: 10.1016/S1474-4422(25)00076-6. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) collected during the trial will be made available to qualified researchers who provide a methodologically sound proposal to achieve aims outlined in the approved proposal.
Related trials for Hypertension (HTN)
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 2
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
Pheochromocytoma, Paraganglioma
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.
Abolfazl Avan, MD, PhD. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BASIC-S Intervention in people with Hypertension (HTN) and Vascular Diseases, run by Andrew Appleton at 1 site in Canada.
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 4 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: opening soon, as of the sponsor's last update on 25 Aug 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 Canada. 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?
Contact Andrew J Appleton, MD, FRCPC. (519-685-8500 ext. 33071, andrew.appleton@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: At the conclusion of the 5-month recruitment period.). 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 NCT07755631, 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 25 Aug 2026.