Coronary Artery DiseaseHIIT-NoWNCT05434117
Feasibility of High-Intensity Interval Nordic Walking in Patients With Coronary Artery Disease
A study testing High-intensity interval Nordic walking and Standard cardiovascular rehabilitation in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
Coronary revascularization, such as heart bypass surgery (CABG) and percutaneous coronary intervention (PCI [inserting a stent to open up blood vessels]) improve survival for people with coronary artery disease. Yet, many patients suffer from poor physical and mental health after coronary revascularization. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- High-intensity interval Nordic walking and Standard cardiovascular rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 9 Dec 2022to Apr 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with coronary artery disease treated with PCI or CABG;
- willing to come onsite for exercise sessions;
- able to perform a cardiopulmonary exercise testing (CPET); and,
- at least 40 years of age.
Who cannot join
- currently participating in a CR program;
- unstable angina or established diagnosis of atrial fibrillation, chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy; or,
- unable to return for 10-week follow-up visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Preliminary Efficacy of High-intensity Interval Nordic Walking in Patients With Coronary Artery Disease: A Pilot Randomized Clinical Trial (HIIT-NoW)
Coronary revascularization, such as heart bypass surgery (CABG) and percutaneous coronary intervention (PCI [inserting a stent to open up blood vessels]) improve survival for people with coronary artery disease. Yet, many patients suffer from poor physical and mental health after coronary revascularization. Traditional cardiac rehabilitation involving moderate-to-vigorous intensity continuous training (MICT) improves physical and mental health. However, alternative exercise programs, such as high-intensity interval training (HIIT) and Nordic walking may provide superior benefits. Nordic walking is like Nordic skiing but uses specifically designed poles for walking. Nordic walking involved core, upper and lower body muscles, resulting in greater energy expenditure while reducing loading stress at the knee. To date, HIIT used in cardiac rehabilitation settings has focused on lower body (e.g., leg cycling). The investigators are not aware of HIIT protocols that target both upper and lower body at the same time. An exercise program that combines HIIT and Nordic walking (HIIT-NoW) may offer an alternative time-efficient whole-body exercise to improve physical and mental health. This study will test if HIIT-NoW can be an alternative exercise option to improve physical and mental health in patients with coronary artery disease.
Read the detailed description
Coronary revascularization improves survival for patients with coronary artery disease (CAD). Despite successful coronary revascularization treatment, however, many patients with CAD are left suffering from poor exercise capacity and frequently experience difficulties in performing daily activities (e.g., getting dressed, sitting down or getting up from the toilet) because of diminished cardiovascular function and exercise tolerance. Decreased exercise capacity leads to a dramatic reduction in quality of life (QoL) and more severe depression symptoms. Low exercise capacity, poor quality of life (QoL) and severer depression symptoms heighten the risk of subsequent cardiovascular events and mortality.
Current guidelines recommend that persons with CAD who have undergone coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) participate in exercise-based cardiovascular rehabilitation (CR). Exercise-based CR is safe, effective and a class IA recommendation following CABG and PCI. Irrefutable evidence demonstrates that exercise-based CR including moderate-to-vigorous intensity continuous exercise training (MICT) improves exercise capacity, QoL, depression and reduces hospital readmissions and cardiovascular morbidity and mortality. MICT has long been used to manage the physical and mental health of CAD patients as per the Canadian Guidelines for Cardiovascular Rehabilitation and Cardiovascular Disease Prevention; however, such exercise may be less efficient and perceived as less motivating/enjoyable. Growing evidence suggests that non-conventional exercise interventions, such as high-intensity interval training (HIIT) and Nordic walking are more effective exercise modalities, and maybe more enjoyable, to improve clinical outcomes (e.g., exercise capacity, QoL, and depression symptoms) in patients with CAD.
HIIT (repeated bouts of brief high-intensity exercise interspersed with active recovery) is an effective and efficient exercise training paradigm. A recent meta-analysis (n=10 studies) comparing HIIT and MICT in patients with CAD suggests that: (1) HIIT is superior to MICT in improving cardiorespiratory fitness (V̇O2peak) of patients with CAD, an important clinical vital sign and strong predictor of mortality; and, (2) HIIT and MICT are equally effective in improving QoL and depression symptoms in patients including CAD. Increases in cardiorespiratory fitness decrease mortality risk -- every 3.5 ml/kg/min increase in V̇O2peak yields a 13% improvement in survival. Exercise training-induced increases in cardiorespiratory fitness are therefore highly desirable for the improvement of important patient outcomes.
Nordic walking is similar to Nordic skiing but uses specifically designed poles for walking. Nordic walking includes the recruitment of core, upper and lower body muscles, resulting in greater exergy expenditure while reducing loading stress at the knee joint. Regular participation in Nordic walking leads to increased exercise capacity. Although data is limited regarding the impact of Nordic walking in comparison to MICT on mental health in patients with CAD, some studies in patients with heart failure have shown superior improvements in QoL and fewer depressive symptoms following Nordic walking when compared to MICT. Our previous randomized controlled trial simultaneously comparing 12 weeks of supervised HIIT, MICT and Nordic walking in patients with CAD showed that Nordic walking was statistically and clinically superior in increasing functional capacity (i.e., distance walked over 6 minutes), and have similar effects on QoL and depression when compared to HIIT or MICT.
As many adults with cardiovascular disease consider lack of time a barrier to exercise, HIIT may be an appealing exercise training paradigm as cardiovascular health benefits can be achieved in less time when compared to MICT. HIIT may also address other frequently reported deterrents to MICT, including lack of interest and motivation, boredom, not challenging enough, and tailored for older people's needs. To date, HIIT used in CR settings has predominantly focused on lower body (e.g., leg cycling). There are few HIIT protocols that simultaneously target both upper and lower body, such as high-intensity interval Nordic walking (HIIT-NoW). Studies have shown that HIIT and Nordic walking are feasible, enjoyable and have similar or superior effects on physical and mental health when compared to MICT. By combining HIIT and Nordic walking, HIIT-NoW may offer an alternative time-efficient whole-body exercise to improve physical and mental health of patients with CAD.
- Conditions
- Coronary Artery Disease
- Being tested
- High-intensity interval Nordic walking, Standard cardiovascular rehabilitation
- Keywords
- High-intensity interval training, Nordic walking
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval Nordic walkingBehavioural
Participants will complete supervised exercise sessions twice weekly for 10 weeks. Exercise specialists will educate participants in proper use of walking poles and basic Nordic walking techniques and supervise the exercise training sessions. HIIT-NoW will be 45 min in duration using Nordic poles and consists of (i) a 10-min warm-up at 30-59% heart rate reserve (HRR, light-to-moderate intensity); (ii) 4 × 4 min of high-intensity work periods at 60-89% HRR (vigorous intensity) interspersed with 3 min of low-intensity work periods at 30-59% HRR (light-to-moderate intensity); and, (iii) a 10-min cooldown at 30-39% HRR (light intensity). To allow participants to acclimatize to the HIIT-NoW protocol, the training intensity will target 60-69% HRR for the first week, 70-79% HRR in the second week, and 80-89% HRR from the third week onward. If participants do not tolerate 89% HRR well, they will exercise as close to 89% HRR as possible.
Standard cardiovascular rehabilitationBehavioural
Individuals assigned to standard CR will attend onsite exercise-based CR comprised of one onsite exercise session per week for 8-10 weeks. The onsite CR offers exercise sessions tailored to the fitness of patients and strengthening exercise.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval Nordic walking | Experimental | Participants will receive high-intensity interval Nordic walking training. Receives: Behavioral: High-intensity interval Nordic walking |
| Control | Active comparator | Participants will undergo standard cardiovascular rehabilitation. Receives: Behavioral: Standard cardiovascular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment will be assessed for feasibility. Recruitment will be assessed by the proportion of patients remained interested and randomized after being informed of the requirements of the study
Measured: Baseline to week 11 follow up
Adherence
Adherence will be assessed for feasibility. Adherence will be assessed by the attendance to the prescribed exercise sessions
Measured: Baseline to week 11 follow up
Compliance
Compliance will be assessed for feasibility. Compliance will be assessed by the proportion of participants adhering to prescribed exercise intensity. All HIIT-NoW sessions will be monitored by study personnel and compliance to prescribed exercise intensity will be assessed for each exercise session.
Measured: Baseline to week 11 follow up
Adverse events
Safety will be assessed for feasibility. All mild, moderate, and severe symptoms and adverse events throughout this study will be recorded.
Measured: Baseline to week 11 follow up
Subjective exercise experiences
Subjective exercise experiences will be assessed for feasibility. Physical activity enjoyment will be collected using the PACES.
Measured: Baseline to week 11 follow up
Self-efficacy
Self-efficacy will be assessed for feasibility. Exercise self-efficacy will be assessed using the MSES-R.
Measured: Baseline to week 11 follow up
Secondary outcomes (12)
Cardiorespiratory fitness
Cardiorespiratory fitness (V̇O2peak) will be measured by a symptom-limited CPET.
Measured: Baseline to week 11 follow up
Functional capacity
Functional capacity will be assessed by the 6-minute walk test.
Measured: Baseline to week 11 follow up
Fat mass
Fat mass (kg) will be measured using bioelectrical impedance analysis.
Measured: Baseline to week 11 follow up
Quality of life (QoL)
General Quality of life will be assessed using the Medical Outcomes Study Short Form-36. Higher scores indicate better QoL
Measured: Baseline to week 11 follow up
Heart Disease specific Quality of life (HeartQoL)
Heart Disease specific Quality of life (HeartQoL) will be assessed using the disease-specific quality of life questionnaire. Higher scores indicate better HeartQoL (0-3 points).
Measured: Baseline to week 11 follow up
Depression
Depression: will be assessed by the Beck Depression Inventory-II. Higher scores indicate more severe depression symptoms.
Measured: Baseline to week 11 follow up
Gender
Gender: will be assessed using the Genesis-Praxy questionnaire.
Measured: Baseline to week 11 follow up
Physical activity levels
Physical activity levels: Participants will wear a activity monitor (Actigraph GT3X) over the right hip for a week at baseline and follow-up.
Measured: Baseline to week 11 follow up
Subjective functinal capacity
Subjective functional capacity will be assessed by the Duke Activity Status Index questionnaire.
Measured: Baseline to week 11 follow up
Fat-free mass
Fat-free mass (kg) will be measured using bioelectrical impedance analysis.
Measured: Baseline to week 11 follow up
Waist circumference
Waist circumference (cm) will be measured by standardized procedures using a Seca tape measure.
Measured: Baseline to week 11 follow up
Blood pressure
Resting blood pressure will be measured in a seated position after a 5-minute rest period using an automated monitor.
Measured: Baseline to week 11 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start9 Dec 2022
- Primary completion3 Jun 2026
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group pilot RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer L Reed, PhD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434117
- Sponsor's protocol ID
- 20220260
- Acronym
- HIIT-NoW
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of High-intensity Interval Nordic Walking in Patients With Coronary Artery Disease: A Pilot Randomized Clinical Trial (HIIT-NoW)
- ClinicalTrials.gov ID
- NCT05434117
- Acronym / sponsor ID
- HIIT-NoW / 20220260
- Conditions
- Coronary Artery Disease
- Keywords
- High-intensity interval training, Nordic walking
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 3 Jun 2026 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Jun 2022 (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.
Coronary revascularization, such as heart bypass surgery (CABG) and percutaneous coronary intervention (PCI [inserting a stent to open up blood vessels]) improve survival for people with coronary artery disease. Yet, many patients suffer from poor physical and mental health after coronary revascularization. Traditional cardiac rehabilitation involving moderate-to-vigorous intensity continuous training (MICT) improves physical and mental health. However, alternative exercise programs, such as high-intensity interval training (HIIT) and Nordic walking may provide superior benefits. Nordic walking is like Nordic skiing but uses specifically designed poles for walking. Nordic walking involved core, upper and lower body muscles, resulting in greater energy expenditure while reducing loading stress at the knee. To date, HIIT used in cardiac rehabilitation settings has focused on lower body (e.g., leg cycling). The investigators are not aware of HIIT protocols that target both upper and lower body at the same time. An exercise program that combines HIIT and Nordic walking (HIIT-NoW) may offer an alternative time-efficient whole-body exercise to improve physical and mental health. This study will test if HIIT-NoW can be an alternative exercise option to improve physical and mental health in patients with coronary artery disease.
Detailed description
Coronary revascularization improves survival for patients with coronary artery disease (CAD). Despite successful coronary revascularization treatment, however, many patients with CAD are left suffering from poor exercise capacity and frequently experience difficulties in performing daily activities (e.g., getting dressed, sitting down or getting up from the toilet) because of diminished cardiovascular function and exercise tolerance. Decreased exercise capacity leads to a dramatic reduction in quality of life (QoL) and more severe depression symptoms. Low exercise capacity, poor quality of life (QoL) and severer depression symptoms heighten the risk of subsequent cardiovascular events and mortality.
Current guidelines recommend that persons with CAD who have undergone coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) participate in exercise-based cardiovascular rehabilitation (CR). Exercise-based CR is safe, effective and a class IA recommendation following CABG and PCI. Irrefutable evidence demonstrates that exercise-based CR including moderate-to-vigorous intensity continuous exercise training (MICT) improves exercise capacity, QoL, depression and reduces hospital readmissions and cardiovascular morbidity and mortality. MICT has long been used to manage the physical and mental health of CAD patients as per the Canadian Guidelines for Cardiovascular Rehabilitation and Cardiovascular Disease Prevention; however, such exercise may be less efficient and perceived as less motivating/enjoyable. Growing evidence suggests that non-conventional exercise interventions, such as high-intensity interval training (HIIT) and Nordic walking are more effective exercise modalities, and maybe more enjoyable, to improve clinical outcomes (e.g., exercise capacity, QoL, and depression symptoms) in patients with CAD.
HIIT (repeated bouts of brief high-intensity exercise interspersed with active recovery) is an effective and efficient exercise training paradigm. A recent meta-analysis (n=10 studies) comparing HIIT and MICT in patients with CAD suggests that: (1) HIIT is superior to MICT in improving cardiorespiratory fitness (V̇O2peak) of patients with CAD, an important clinical vital sign and strong predictor of mortality; and, (2) HIIT and MICT are equally effective in improving QoL and depression symptoms in patients including CAD. Increases in cardiorespiratory fitness decrease mortality risk -- every 3.5 ml/kg/min increase in V̇O2peak yields a 13% improvement in survival. Exercise training-induced increases in cardiorespiratory fitness are therefore highly desirable for the improvement of important patient outcomes.
Nordic walking is similar to Nordic skiing but uses specifically designed poles for walking. Nordic walking includes the recruitment of core, upper and lower body muscles, resulting in greater exergy expenditure while reducing loading stress at the knee joint. Regular participation in Nordic walking leads to increased exercise capacity. Although data is limited regarding the impact of Nordic walking in comparison to MICT on mental health in patients with CAD, some studies in patients with heart failure have shown superior improvements in QoL and fewer depressive symptoms following Nordic walking when compared to MICT. Our previous randomized controlled trial simultaneously comparing 12 weeks of supervised HIIT, MICT and Nordic walking in patients with CAD showed that Nordic walking was statistically and clinically superior in increasing functional capacity (i.e., distance walked over 6 minutes), and have similar effects on QoL and depression when compared to HIIT or MICT.
As many adults with cardiovascular disease consider lack of time a barrier to exercise, HIIT may be an appealing exercise training paradigm as cardiovascular health benefits can be achieved in less time when compared to MICT. HIIT may also address other frequently reported deterrents to MICT, including lack of interest and motivation, boredom, not challenging enough, and tailored for older people's needs. To date, HIIT used in CR settings has predominantly focused on lower body (e.g., leg cycling). There are few HIIT protocols that simultaneously target both upper and lower body, such as high-intensity interval Nordic walking (HIIT-NoW). Studies have shown that HIIT and Nordic walking are feasible, enjoyable and have similar or superior effects on physical and mental health when compared to MICT. By combining HIIT and Nordic walking, HIIT-NoW may offer an alternative time-efficient whole-body exercise to improve physical and mental health of patients with CAD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group pilot RCT
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval Nordic walking | Experimental | Behavioral: High-intensity interval Nordic walkingParticipants will receive high-intensity interval Nordic walking training. |
| Control | Active comparator | Behavioral: Standard cardiovascular rehabilitationParticipants will undergo standard cardiovascular rehabilitation. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with coronary artery disease treated with PCI or CABG;
- willing to come onsite for exercise sessions;
- able to perform a cardiopulmonary exercise testing (CPET); and,
- at least 40 years of age.
Key exclusion criteria (3 listed)
- currently participating in a CR program;
- unstable angina or established diagnosis of atrial fibrillation, chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy; or,
- unable to return for 10-week follow-up visit.
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 |
|---|---|---|
| High-intensity interval Nordic walkingParticipants will complete supervised exercise sessions twice weekly for 10 weeks. Exercise specialists will educate participants in proper use of walking poles and basic Nordic walking techniques and supervise the exercise training sessions. HIIT-NoW will be 45 min in duration using Nordic poles and consists of (i) a 10-min warm-up at 30-59% heart rate reserve (HRR, light-to-moderate intensity); (ii) 4 × 4 min of high-intensity work periods at 60-89% HRR (vigorous intensity) interspersed with 3 min of low-intensity work periods at 30-59% HRR (light-to-moderate intensity); and, (iii) a 10-min cooldown at 30-39% HRR (light intensity). To allow participants to acclimatize to the HIIT-NoW protocol, the training intensity will target 60-69% HRR for the first week, 70-79% HRR in the second week, and 80-89% HRR from the third week onward. If participants do not tolerate 89% HRR well, they will exercise as close to 89% HRR as possible. | Behavioural | High-intensity interval Nordic walking |
| Standard cardiovascular rehabilitationIndividuals assigned to standard CR will attend onsite exercise-based CR comprised of one onsite exercise session per week for 8-10 weeks. The onsite CR offers exercise sessions tailored to the fitness of patients and strengthening exercise. | Behavioural | Control |
Primary outcome
Recruitment
Time frame: Baseline to week 11 follow up
Recruitment will be assessed for feasibility. Recruitment will be assessed by the proportion of patients remained interested and randomized after being informed of the requirements of the study
Adherence
Time frame: Baseline to week 11 follow up
Adherence will be assessed for feasibility. Adherence will be assessed by the attendance to the prescribed exercise sessions
Compliance
Time frame: Baseline to week 11 follow up
Compliance will be assessed for feasibility. Compliance will be assessed by the proportion of participants adhering to prescribed exercise intensity. All HIIT-NoW sessions will be monitored by study personnel and compliance to prescribed exercise intensity will be assessed for each exercise session.
Adverse events
Time frame: Baseline to week 11 follow up
Safety will be assessed for feasibility. All mild, moderate, and severe symptoms and adverse events throughout this study will be recorded.
Subjective exercise experiences
Time frame: Baseline to week 11 follow up
Subjective exercise experiences will be assessed for feasibility. Physical activity enjoyment will be collected using the PACES.
Self-efficacy
Time frame: Baseline to week 11 follow up
Self-efficacy will be assessed for feasibility. Exercise self-efficacy will be assessed using the MSES-R.
12 secondary outcomes
Cardiorespiratory fitness
Time frame: Baseline to week 11 follow up
Functional capacity
Time frame: Baseline to week 11 follow up
Fat mass
Time frame: Baseline to week 11 follow up
Quality of life (QoL)
Time frame: Baseline to week 11 follow up
Heart Disease specific Quality of life (HeartQoL)
Time frame: Baseline to week 11 follow up
Depression
Time frame: Baseline to week 11 follow up
Gender
Time frame: Baseline to week 11 follow up
Physical activity levels
Time frame: Baseline to week 11 follow up
Subjective functinal capacity
Time frame: Baseline to week 11 follow up
Fat-free mass
Time frame: Baseline to week 11 follow up
Waist circumference
Time frame: Baseline to week 11 follow up
Blood pressure
Time frame: Baseline to week 11 follow up
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 1 Jul 2026.
- 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.
Jennifer L Reed, PhD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval Nordic walking and Standard cardiovascular rehabilitation in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation 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 4 inclusion and 3 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 1 Jul 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?
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?
Recruitment (time frame: Baseline to week 11 follow up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.