Heart Failure With Preserved Ejection FractionNCT05582044
Exercise Lower-body Negative Pressure in Heart Failure With Preserved Ejection Fraction
A study testing Lower-body Negative Pressure (-25 mmHg), Lower-body Negative Pressure (-15 mmHg) and Lower-body Neutral Pressure (0 mmHg) in people with Heart Failure With Preserved Ejection Fraction, run by University of British Columbia at 1 site in Canada.
Trial summary
The heart is a pump that must both fill and empty effectively to move blood; if it cannot move enough, heart failure may ensue. Approximately half of all adults living with heart failure have a form where the heart stiffens, which impairs its ability to fill. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Lower-body Negative Pressure (-25 mmHg), Lower-body Negative Pressure (-15 mmHg) and Lower-body Neutral Pressure (0 mmHg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jan 2023to Jan 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with a clinical diagnosis of HFpEF (LV ejection fraction ≥50%) measured in the year prior to Visit 1 (and confirmed at Visit 1), who are New York Heart Association Functional Class II-III (mild-moderate symptoms), ambulatory, receiving guideline-directed medical therapy unchanged for ≥2 months, and clinically stable for ≥3 months.
- Symptom(s) of heart failure requiring treatment within the year prior to Visit 1
- NT-proBNP >50 pmol/L (sinus rhythm) or >150 pmol/L (atrial fibrillation in year prior)
- Diastolic dysfunction based on at least one of the following echocardiographic findings:
- Left atrial enlargement (diameter >4 cm or volume index >28 mL/m2); or
- e' <10 cm/s (lateral) or <8 cm/s (septal), or
- E/e' >10 (lateral), or >15 (septal)
- Healthy sedentary or recreationally active adults from the community
Who cannot join
- Any prior measurement demonstrated LV ejection fraction ≤40%
- Primary pulmonary, metabolic, renal, hepatic, neuromuscular, or malignant disease
- Primary pulmonary vascular, complex congenital, or > mild valvular heart disease
- Documented infiltrative cardiomyopathy
- Documented valvular or coronary disease requiring intervention
- Myocarditis, pericardial effusion, acute coronary syndrome, or revascularization in the last 3 months
Show all 27Show fewer
- Resting seated systolic blood pressure >160 mmHg or <100 mmHg
- Jugular venous pressure >12 cm
- Inferior vena cava >2 cm with no inspiratory collapse, or severe right ventricular dysfunction by echo
- Ambulatory supplemental oxygen
- Current or recent participation in >150 min. per week of moderate intensity exercise
- Current or recent (within the past 6 months) smoking
- Body mass index >35 kg/m2
- Contraindication to exercise or otherwise unable to perform cycle ergometry
- Poor echocardiographic imaging windows
- Current or recent participation in >150 min. per week of moderate intensity exercise
- History of any cardiovascular condition or cardioactive drug use
- History of any respiratory condition including asthma
- History of any metabolic condition including diabetes
- Non-sinus rhythm
- Echocardiographic evidence of significant left ventricular hypertrophy, valvular abnormalities, left ventricular ejection fraction <50%, or diastolic dysfunction as described in HFpEF inclusion criteria.
- Seated blood pressure ≥140/90 mmHg
- Any other chronic systemic illness
- Current or recent (within the past 6 months) smoking
- Body mass index >35 kg/m2
- Contraindication to exercise or otherwise unable to perform cycle ergometry
- Poor echocardiographic imaging windows
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Kelowna, British Columbia, V1V1V7
Stephen Wright, PhD, 250-807-9676, stephen.wright@ubc.ca
About this study
Official title: The Effect of Lower-body Negative Pressure on Exercise Tolerance and Mechanisms of Dyspnea in Heart Failure With Preserved Ejection Fraction
The heart is a pump that must both fill and empty effectively to move blood; if it cannot move enough, heart failure may ensue. Approximately half of all adults living with heart failure have a form where the heart stiffens, which impairs its ability to fill. This form of heart failure particularly affects females and older adults. When people exercise, extra blood returns to the heart. The healthy heart can easily fill and move this extra blood to the muscles. However, when the heart's ability to fill is impaired, the extra blood can back up and pool in the lungs. Blood pooling in the lungs makes people feel breathless, although the investigators do not fully understand why, and this form of heart failure has a high risk of hospitalization and death, but few effective treatments are available. Exercise is one of the few treatments that works well if enough exercise is performed regularly. However, many people with this form of heart failure can only tolerate a small amount before stopping due to severe breathlessness, which can put them off from exercising regularly.
The study's goal is to help these people perform more exercise. The investigators will use a novel form of stationary cycling with a plastic chamber around the lower body that seals at the waist. The chamber can apply suction to the lower body during exercise which will reduce how much extra blood returns and prevent the heart and lungs from being overloaded. Participants will attend 5 visits, including 3 where they will perform a submaximal exercise test for as many minutes as possible with or without light suction. In each of these tests, the investigators will record how long they exercise and ask them to rate how breathless they feel. The investigators will also study their breathing pattern, using a mouthpiece and pressure sensor, and heart function, using ultrasound imaging.
This work will help adults living with heart failure exercise more and improve their health, and help researchers understand what causes breathlessness and develop new treatments.
Read the detailed description
Heart failure is a major public health issue, affecting >750,000 Canadians and >6 million Americans. Half of all adults with heart failure have a preserved ejection fraction (HFpEF), where left ventricular (LV) diastolic dysfunction (impaired filling) is a key abnormality. These adults have few treatment options other than diuretics and exercise training, but dyspnea (a subjective experience of breathing discomfort) on exertion is a hallmark of HFpEF that causes anxiety, activity avoidance, and a spiral of deconditioning leading to worsening dyspnea and prognosis. Mechanisms of dyspnea on exertion are not well understood in HFpEF, but marked increases in LV filling pressure occur that are associated with lung congestion and interstitial fluid accumulation, which stimulates intrapulmonary afferents and impairs breathing mechanics. During exercise, venous return to the heart increases. This augments stroke volume in health but may overload the LV with diastolic dysfunction and drive lung congestion in HFpEF. As such, attenuating the increase in venous return during exercise may reduce congestion, alleviate dyspnea, and improve exercise tolerance in HFpEF. This concept has been demonstrated by invasively reducing venous return, but the safety and feasibility of invasive approaches is unclear. Lower-body negative pressure (LBNP) is a novel, safe and effective non-invasive means to attenuate venous return that can be applied during cycle exercise and may provide considerable benefit.
Study Aims
- To investigate whether LBNP can improve exercise tolerance assessed as the time to exercise limitation (TLIM) during constant work-rate exercise in adults with HFpEF.
- To investigate whether LBNP can attenuate the sensory and affective dimensions of dyspnea during exercise in HFpEF.
Exploratory: To examine the effects of LBNP on central hemodynamics and breathing mechanics during exercise in HFpEF, to explore their relationship with exercise tolerance and dyspnea, and to investigate sex-related differences in these responses and relationships.
Main Endpoints
Primary: Time to exercise limitation (Tlim) measured in seconds during submaximal constant work-rate exercise.
Secondary: Dyspnea intensity measured in Borg units during submaximal constant work-rate exercise.
Study Design
Prospective, two-group (HFpEF and Control), double-blind cross-over study with randomized repeated-measures
Treatment: Lower-body negative pressure (-15 mmHg or -25 mmHg); Placebo: Lower-body atmospheric pressure (0 mmHg)
Study Visits:
Visit 1 [2.0-2.5 hours]: Screening, Enrolment, Phenotyping, and Baseline Testing including anthropometrics, blood pressure, an echocardiogram, pulmonary function tests, and an incremental cardiopulmonary exercise test with 12-lead electrocardiogram.
Visit 2 [0.5 hours]: Venous blood sample for complete blood count (CBC) and B-type natriuretic peptide (NT-proBNP).
Visits 3-5 [1.0-1.5 hours each]: Submaximal Exercise with or without Lower-body Negative Pressure. Participants will undergo assessments of ventilatory and cardiac function while performing 1 submaximal cycle exercise trial per visit with lower-body pressure applied at 0 mmHg, -15 mmHg, or -25 mmHg.
Statistical Analysis
Statistical analyses will be performed using SPSS Statistics (V.28, IBM Inc). Normality will be assessed by the Kolmogorov-Smirnov test. If all compared groups or conditions approximate a normal distribution, data will be presented as mean ± standard deviation with paired comparisons made using t-tests. Otherwise, data will be presented as median (inter-quartile range) with paired comparisons made using the Mann-Whitney U or Wilcoxon Signed Rank tests. Omnibus testing will be conducted using analysis of variance, the Friedman test, or the Kruskal-Wallis test with significant effects tested post hoc using Bonferroni-adjusted t-tests or Dunn's tests. Categorical variables will be summarized as proportions and between-group comparisons will be made using the χ2 test. A two-tailed p <0.05 will be considered significant.
- Being tested
- Lower-body Negative Pressure (-25 mmHg), Lower-body Negative Pressure (-15 mmHg), Lower-body Neutral Pressure (0 mmHg)
- Keywords
- Heart Failure, Diastolic Dysfunction, Exercise Intolerance, Dyspnea, Pulmonary Congestion, Pulmonary Hemodynamics
- Medical subject headings
- Heart Failure, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower-body Negative Pressure (-25 mmHg)Other
The LBNP chamber will be sealed at the waist prior to Control measures, and the vacuum system will be activated to coincide with the onset of exercise, applying -25mmHg LBNP.
Lower-body Negative Pressure (-15 mmHg)Other
The LBNP chamber will be sealed at the waist prior to Control measures, and the vacuum system will be activated to coincide with the onset of exercise, applying -15mmHg LBNP.
Lower-body Neutral Pressure (0 mmHg)Other
In this placebo trial, the LBNP chamber will be sealed at the waist prior to Control measures, and the vacuum system will be activated to coincide with the onset of exercise, but the chamber will be vented to atmosphere.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure with Preserved Ejection Fraction (40 Participants) | Experimental | Lower-body negative pressure (-15 and -25 mmHg) and neutral pressure (0 mmHg) Receives: Other: Lower-body Negative Pressure (-25 mmHg); Other: Lower-body Negative Pressure (-15 mmHg); Other: Lower-body Neutral Pressure (0 mmHg) |
| Healthy Controls (20 Participants) | Active comparator | Lower-body negative pressure (-15 and -25 mmHg) and neutral pressure (0 mmHg) Receives: Other: Lower-body Negative Pressure (-25 mmHg); Other: Lower-body Negative Pressure (-15 mmHg); Other: Lower-body Neutral Pressure (0 mmHg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to exercise limitation (Tlim)
Exercise will be performed to exhaustion or symptom limitation, and the Tlim will be recorded at the time of cessation to the second
Measured: Within 30 minutes of exercise onset
Secondary outcomes (1)
Dyspnea intensity and unpleasantness
Participants will be asked to rate their dyspnea intensity and dyspnea unpleasantness each out of 10 using the modified Borg scale. Endpoints will be examined at baseline, exercise limitation, and an 'iso-time' defined as the Tlim of the shortest of the 3 tests.
Measured: Within 30 minutes of exercise onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start25 Jan 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Double-blind, placebo-controlled with randomized repeated measures
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Eves, University of British Columbia
- Investigators
- Neil D Eves, PhD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582044
- Sponsor's protocol ID
- H22-01882
- Status last verified
- Apr 2025
- First submitted
- 12 Oct 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lower-body Negative Pressure on Exercise Tolerance and Mechanisms of Dyspnea in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT05582044
- Acronym / sponsor ID
- H22-01882
- Keywords
- Heart Failure, Diastolic Dysfunction, Exercise Intolerance, Dyspnea, Pulmonary Congestion, Pulmonary Hemodynamics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 17 Oct 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.
The heart is a pump that must both fill and empty effectively to move blood; if it cannot move enough, heart failure may ensue. Approximately half of all adults living with heart failure have a form where the heart stiffens, which impairs its ability to fill. This form of heart failure particularly affects females and older adults. When people exercise, extra blood returns to the heart. The healthy heart can easily fill and move this extra blood to the muscles. However, when the heart's ability to fill is impaired, the extra blood can back up and pool in the lungs. Blood pooling in the lungs makes people feel breathless, although the investigators do not fully understand why, and this form of heart failure has a high risk of hospitalization and death, but few effective treatments are available. Exercise is one of the few treatments that works well if enough exercise is performed regularly. However, many people with this form of heart failure can only tolerate a small amount before stopping due to severe breathlessness, which can put them off from exercising regularly.
The study's goal is to help these people perform more exercise. The investigators will use a novel form of stationary cycling with a plastic chamber around the lower body that seals at the waist. The chamber can apply suction to the lower body during exercise which will reduce how much extra blood returns and prevent the heart and lungs from being overloaded. Participants will attend 5 visits, including 3 where they will perform a submaximal exercise test for as many minutes as possible with or without light suction. In each of these tests, the investigators will record how long they exercise and ask them to rate how breathless they feel. The investigators will also study their breathing pattern, using a mouthpiece and pressure sensor, and heart function, using ultrasound imaging.
This work will help adults living with heart failure exercise more and improve their health, and help researchers understand what causes breathlessness and develop new treatments.
Detailed description
Heart failure is a major public health issue, affecting >750,000 Canadians and >6 million Americans. Half of all adults with heart failure have a preserved ejection fraction (HFpEF), where left ventricular (LV) diastolic dysfunction (impaired filling) is a key abnormality. These adults have few treatment options other than diuretics and exercise training, but dyspnea (a subjective experience of breathing discomfort) on exertion is a hallmark of HFpEF that causes anxiety, activity avoidance, and a spiral of deconditioning leading to worsening dyspnea and prognosis. Mechanisms of dyspnea on exertion are not well understood in HFpEF, but marked increases in LV filling pressure occur that are associated with lung congestion and interstitial fluid accumulation, which stimulates intrapulmonary afferents and impairs breathing mechanics. During exercise, venous return to the heart increases. This augments stroke volume in health but may overload the LV with diastolic dysfunction and drive lung congestion in HFpEF. As such, attenuating the increase in venous return during exercise may reduce congestion, alleviate dyspnea, and improve exercise tolerance in HFpEF. This concept has been demonstrated by invasively reducing venous return, but the safety and feasibility of invasive approaches is unclear. Lower-body negative pressure (LBNP) is a novel, safe and effective non-invasive means to attenuate venous return that can be applied during cycle exercise and may provide considerable benefit.
Study Aims
- To investigate whether LBNP can improve exercise tolerance assessed as the time to exercise limitation (TLIM) during constant work-rate exercise in adults with HFpEF.
- To investigate whether LBNP can attenuate the sensory and affective dimensions of dyspnea during exercise in HFpEF.
Exploratory: To examine the effects of LBNP on central hemodynamics and breathing mechanics during exercise in HFpEF, to explore their relationship with exercise tolerance and dyspnea, and to investigate sex-related differences in these responses and relationships.
Main Endpoints
Primary: Time to exercise limitation (Tlim) measured in seconds during submaximal constant work-rate exercise.
Secondary: Dyspnea intensity measured in Borg units during submaximal constant work-rate exercise.
Study Design
Prospective, two-group (HFpEF and Control), double-blind cross-over study with randomized repeated-measures
Treatment: Lower-body negative pressure (-15 mmHg or -25 mmHg); Placebo: Lower-body atmospheric pressure (0 mmHg)
Study Visits:
Visit 1 [2.0-2.5 hours]: Screening, Enrolment, Phenotyping, and Baseline Testing including anthropometrics, blood pressure, an echocardiogram, pulmonary function tests, and an incremental cardiopulmonary exercise test with 12-lead electrocardiogram.
Visit 2 [0.5 hours]: Venous blood sample for complete blood count (CBC) and B-type natriuretic peptide (NT-proBNP).
Visits 3-5 [1.0-1.5 hours each]: Submaximal Exercise with or without Lower-body Negative Pressure. Participants will undergo assessments of ventilatory and cardiac function while performing 1 submaximal cycle exercise trial per visit with lower-body pressure applied at 0 mmHg, -15 mmHg, or -25 mmHg.
Statistical Analysis
Statistical analyses will be performed using SPSS Statistics (V.28, IBM Inc). Normality will be assessed by the Kolmogorov-Smirnov test. If all compared groups or conditions approximate a normal distribution, data will be presented as mean ± standard deviation with paired comparisons made using t-tests. Otherwise, data will be presented as median (inter-quartile range) with paired comparisons made using the Mann-Whitney U or Wilcoxon Signed Rank tests. Omnibus testing will be conducted using analysis of variance, the Friedman test, or the Kruskal-Wallis test with significant effects tested post hoc using Bonferroni-adjusted t-tests or Dunn's tests. Categorical variables will be summarized as proportions and between-group comparisons will be made using the χ2 test. A two-tailed p <0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled with randomized repeated measures
| Arm | Type | Receives |
|---|---|---|
| Heart Failure with Preserved Ejection Fraction (40 Participants) | Experimental | Other: Lower-body Negative Pressure (-25 mmHg), Other: Lower-body Negative Pressure (-15 mmHg), Other: Lower-body Neutral Pressure (0 mmHg)Lower-body negative pressure (-15 and -25 mmHg) and neutral pressure (0 mmHg) |
| Healthy Controls (20 Participants) | Active comparator | Other: Lower-body Negative Pressure (-25 mmHg), Other: Lower-body Negative Pressure (-15 mmHg), Other: Lower-body Neutral Pressure (0 mmHg)Lower-body negative pressure (-15 and -25 mmHg) and neutral pressure (0 mmHg) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults with a clinical diagnosis of HFpEF (LV ejection fraction ≥50%) measured in the year prior to Visit 1 (and confirmed at Visit 1), who are New York Heart Association Functional Class II-III (mild-moderate symptoms), ambulatory, receiving guideline-directed medical therapy unchanged for ≥2 months, and clinically stable for ≥3 months.
- Symptom(s) of heart failure requiring treatment within the year prior to Visit 1
- NT-proBNP >50 pmol/L (sinus rhythm) or >150 pmol/L (atrial fibrillation in year prior)
- Diastolic dysfunction based on at least one of the following echocardiographic findings:
- Healthy sedentary or recreationally active adults from the community
Key exclusion criteria (27 listed)
- Any prior measurement demonstrated LV ejection fraction ≤40%
- Primary pulmonary, metabolic, renal, hepatic, neuromuscular, or malignant disease
- Primary pulmonary vascular, complex congenital, or > mild valvular heart disease
- Documented infiltrative cardiomyopathy
- Documented valvular or coronary disease requiring intervention
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 |
|---|---|---|
| Lower-body Negative Pressure (-25 mmHg)The LBNP chamber will be sealed at the waist prior to Control measures, and the vacuum system will be activated to coincide with the onset of exercise, applying -25mmHg LBNP. | Other | Healthy Controls (20 Participants), Heart Failure with Preserved Ejection Fraction (40 Participants) |
| Lower-body Negative Pressure (-15 mmHg)The LBNP chamber will be sealed at the waist prior to Control measures, and the vacuum system will be activated to coincide with the onset of exercise, applying -15mmHg LBNP. | Other | Healthy Controls (20 Participants), Heart Failure with Preserved Ejection Fraction (40 Participants) |
| Lower-body Neutral Pressure (0 mmHg)In this placebo trial, the LBNP chamber will be sealed at the waist prior to Control measures, and the vacuum system will be activated to coincide with the onset of exercise, but the chamber will be vented to atmosphere. | Other | Healthy Controls (20 Participants), Heart Failure with Preserved Ejection Fraction (40 Participants) |
Primary outcome
Time to exercise limitation (Tlim)
Time frame: Within 30 minutes of exercise onset
Exercise will be performed to exhaustion or symptom limitation, and the Tlim will be recorded at the time of cessation to the second
1 secondary outcome
Dyspnea intensity and unpleasantness
Time frame: Within 30 minutes of exercise onset
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 4 Apr 2025.
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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.
Neil D Eves, PhD principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower-body Negative Pressure (-25 mmHg), Lower-body Negative Pressure (-15 mmHg) and Lower-body Neutral Pressure (0 mmHg) in people with Heart Failure With Preserved Ejection Fraction, run by University of British Columbia 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 8 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 4 Apr 2025. 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 Stephen P Wright, PhD ((250) 807-8860, stephen.wright@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to exercise limitation (Tlim) (time frame: Within 30 minutes of exercise onset). 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 4 Apr 2025.