Comparing Lower-body Negative Pressure (-25 mmHg) with Lower-body Negative Pressure (-15 mmHg) for heart failure with preserved ejection fraction
Official title: Exercise Lower-body Negative Pressure in Heart Failure With Preserved Ejection Fraction
The Effect of Lower-body Negative Pressure on Exercise Tolerance and Mechanisms of Dyspnea in Heart Failure With Preserved Ejection Fraction
Interventions
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.
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.
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.
Canadian Sites (1)
University of British Columbia
Kelowna, British Columbia, Canada
Eligibility Criteria
See who this study is looking for68 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +for the HFpEF Group:
- +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)
- +Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → for the Healthy Control GroupControl groupThe group a new treatment is measured against.Read more →:
- +\- Healthy sedentary or recreationally active adults from the community
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for the HFpEF Group:
- +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
- +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
- +Body mass index \>35 kg/m2
- +Contraindication to exercise or otherwise unable to perform cycle ergometry
- +Poor echocardiographic imaging windows
- +Exclusion Criteria for the Healthy Control Group
- +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
- +Body mass index \>35 kg/m2
- +Contraindication to exercise or otherwise unable to perform cycle ergometry
- +Poor echocardiographic imaging windows
- +Current or recent (within the past 6 months) smoking
- +Current or recent (within the past 6 months) smoking
Exclusion
- −for the HFpEF Group:
- −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
- −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
- −Body mass index \>35 kg/m2
- −Contraindication to exercise or otherwise unable to perform cycle ergometry
- −Poor echocardiographic imaging windows
- −Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for the Healthy Control GroupControl groupThe group a new treatment is measured against.Read more →
- −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 criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →.
- −Seated blood pressure ≥140/90 mmHg
- −Any other chronic systemic illness
- −Body mass index \>35 kg/m2
- −Contraindication to exercise or otherwise unable to perform cycle ergometry
- −Poor echocardiographic imaging windows
- −Current or recent (within the past 6 months) smoking
- −Current or recent (within the past 6 months) smoking
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Lower-body Negative Pressure (-25 mmHg), Lower-body Negative Pressure (-15 mmHg), Lower-body Neutral Pressure (0 mmHg).
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 40 years, with no upper limit given.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 60 people.
The study is currently expected to finish around January 2026.
The main measurement is taken over: Within 30 minutes of exercise onset.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to exercise limitation (Tlim) — measured over Within 30 minutes of exercise onset.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05582044 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 40 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 40 years, with no upper limit given.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Within 30 minutes of exercise onset.
The study as a whole is currently expected to finish around 2026-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 60 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Kelowna, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.