Lower-body Negative Pressure Exercise for Heart Failure
Trial Summary
What is the purpose of 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.
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 data supports the effectiveness of the treatment Lower-body Negative Pressure Exercise for Heart Failure?
Exercise training has been shown to improve quality of life and exercise capacity in heart failure patients, with benefits such as better blood flow, improved muscle function, and reduced symptoms. Although the specific treatment of Lower-body Negative Pressure Exercise is not directly studied, similar exercise programs have demonstrated positive effects in heart failure management.12345
Is lower-body negative pressure exercise safe for humans?
Lower-body negative pressure (LBNP) has been used safely in research for decades, particularly in aerospace and military studies, to study blood pressure and cardiovascular responses. It is generally considered safe, though it can cause blood to pool in the lower body, which might lead to fainting in some cases.678910
How does the lower-body negative pressure exercise treatment for heart failure differ from other treatments?
Lower-body negative pressure exercise is unique because it combines physical exercise with a pressure change that mimics the effects of heart failure, potentially improving heart function by enhancing blood circulation and reducing fluid accumulation in the lower body, unlike traditional medications that primarily target heart rate or blood pressure.67111213
Research Team
Neil D Eves, PhD
Principal Investigator
The University of British Columbia
Eligibility Criteria
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
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
Treatment Details
Interventions
- Lower-body Negative Pressure
- Lower-body Neutral Pressure
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Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor