Exercise Lower-body Negative Pressure in Heart Failure With Preserved Ejection Fraction
Recruiting · NCT05582044 · Interventional (participants receive a specific treatment) · Lead sponsor: University of British Columbia
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 Criteria for the Healthy Control Group:
- \- Healthy sedentary or recreationally active adults from the community
Exclusion criteria
- 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
- Current or recent (within the past 6 months) smoking
- 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
- Current or recent (within the past 6 months) smoking
- Body mass index \>35 kg/m2
- Contraindication to exercise or otherwise unable to perform cycle ergometry
- Poor echocardiographic imaging windows
Where it is running
1 location listed.
- University of British Columbia - Kelowna, British Columbia, Canada