Actively Recruiting
Exercise Lower-body Negative Pressure in Heart Failure With Preserved Ejection Fraction
Led by University of British Columbia · Updated on 2025-04-04
60
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exercise Lower-body Negative Pressure in Heart Failure With Preserved Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with clinical diagnosis of HFpEF (LV ejection fraction 50%) confirmed within the past year
- New York Heart Association Functional Class II-III with mild to moderate symptoms
- Able to walk and ambulatory
- Receiving stable guideline-directed medical therapy unchanged for at least 2 months
- Clinically stable for at least 3 months
- Symptoms of heart failure requiring treatment within the past year
- NT-proBNP >50 pmol/L (sinus rhythm) or >150 pmol/L (atrial fibrillation within past year)
- Diastolic dysfunction evidenced by left atrial enlargement, or specific echocardiographic measures
- Healthy sedentary or recreationally active adults for the control group
You will not qualify if you...
- Any prior left ventricular ejection fraction measurement 40%
- Primary pulmonary, metabolic, renal, hepatic, neuromuscular, or malignant diseases
- Primary pulmonary vascular, complex congenital, or more than mild valvular heart disease
- Documented infiltrative cardiomyopathy
- Valvular or coronary disease requiring intervention
- Myocarditis, pericardial effusion, acute coronary syndrome, or revascularization within 3 months
- Resting seated systolic blood pressure >160 mmHg or <100 mmHg
- Jugular venous pressure >12 cm
- Inferior vena cava >2 cm without inspiratory collapse or severe right ventricular dysfunction
- Use of ambulatory supplemental oxygen
- Current or recent participation in >150 minutes per week of moderate intensity exercise
- Current or recent smoking within past 6 months
- Body mass index >35 kg/m2
- Contraindication to exercise or inability to perform cycle ergometry
- Poor echocardiographic imaging windows
- For controls, history of cardiovascular, respiratory, or metabolic conditions; non-sinus rhythm; elevated blood pressure; or chronic systemic illness
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of British Columbia
Kelowna, British Columbia, Canada, V1V1V7
Actively Recruiting
Research Team
S
Stephen P Wright, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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