๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-04-02

Exercise Lower-body Negative Pressure in Heart Failure With Preserved Ejection Fraction (NCT05582044)

The Effect of Lower-body Negative Pressure on Exercise Tolerance and Mechanisms of Dyspnea in Heart Failure With Preserved Ejection Fraction

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿ“‹ Clinical Research Protocol Sponsor: University of British Columbia

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of British Columbia โ€” Kelowna, British Columbia

Age range: 40 Years

๐Ÿงช Interventions in This Study

  • Lower-body Negative Pressure (-25 mmHg) (OTHER)
  • Lower-body Negative Pressure (-15 mmHg) (OTHER)
  • Lower-body Neutral Pressure (0 mmHg) (OTHER)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • University of British Columbia โ€” Kelowna, British Columbia

๐Ÿ“ž Contact the Study Coordinator

Phone: (250) 807-8860

Email: stephen.wright@ubc.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—