Lower-body Negative Pressure Exercise for Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to help individuals with a type of heart failure, where the heart becomes stiff and struggles to fill properly, exercise more easily. It uses a special bike with a chamber around the lower body to reduce extra blood returning to the heart, potentially easing breathlessness during exercise. The method involves lower-body negative pressure, creating a vacuum effect, and lower-body neutral pressure, which does not alter pressure, to observe their effects. Researchers aim to determine if this helps individuals exercise longer and feel less out of breath. Those with heart failure exhibiting mild to moderate symptoms and who have been stable for the past few months might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance exercise capacity for heart failure patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, participants in the heart failure group must have been on stable medical therapy for at least 2 months before joining the study.
What prior data suggests that this lower-body negative pressure exercise is safe for heart failure patients?
Research shows that using lower-body negative pressure to aid exercise in people with heart failure is generally well-tolerated. Related studies have shown promise in helping the heart manage blood flow better during physical activity. This technique uses a chamber that gently pulls on the lower body, reducing the amount of blood returning to the heart and lungs. This can ease exercise for those with heart failure by lessening breathlessness.
No significant reports of harmful effects from this treatment method have emerged so far. Participants usually find it comfortable and safe. As researchers continue to study this approach, they remain vigilant for any possible side effects. However, current findings suggest it is a safe option for those who struggle with heart failure and exercise.12345Why are researchers excited about this trial?
Most treatments for heart failure with preserved ejection fraction focus on managing symptoms with medications like diuretics and beta-blockers. However, the use of lower-body negative pressure (LBNP) is different because it simulates the effects of exercise without actual physical activity. This method works by creating a vacuum around the lower body, which helps improve circulation and mimic the benefits of exercise on the heart. Researchers are excited about LBNP because it offers a non-pharmacological approach that could benefit patients who find traditional exercise challenging or risky. Additionally, it could provide a new avenue for improving heart function and quality of life in this patient group.
What evidence suggests that this lower-body negative pressure exercise is effective for heart failure?
This trial will compare the effects of lower-body negative pressure and lower-body neutral pressure on heart failure with preserved ejection fraction (HFpEF). Research has shown that lower-body suction can help manage HFpEF, where the heart becomes stiff and struggles to fill with blood. Applying suction to the lower body reduces blood flow back to the heart during exercise, preventing the heart and lungs from becoming overwhelmed and making exercise easier. Although data on this method remains limited, the concept suggests it could help people with HFpEF exercise longer and breathe more easily. This approach might offer a new way to improve life for those affected.12356
Who Is on the Research Team?
Neil D Eves, PhD
Principal Investigator
The University of British Columbia
Are You a Good Fit for This Trial?
This trial is for adults with a specific type of heart failure where the heart stiffens and has trouble filling (HFpEF). They should have had symptoms needing treatment in the past year, be somewhat active but not heavily exercising, and their condition should be stable. People can't join if they've had severe heart issues like low ejection fraction or certain diseases, are very overweight, smoke recently, or exercise a lot.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Testing
Enrolment, phenotyping, and baseline testing including anthropometrics, blood pressure, echocardiogram, pulmonary function tests, and an incremental cardiopulmonary exercise test
Treatment
Participants undergo submaximal exercise with or without lower-body negative pressure, with assessments of ventilatory and cardiac function
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lower-body Negative Pressure
- Lower-body Neutral Pressure
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor