Using lower-body negative pressure to improve exercise tolerance in heart failure patients
The Effect of Lower-body Negative Pressure on Exercise Tolerance and Mechanisms of Dyspnea in Heart Failure With Preserved Ejection Fraction
This study is testing if a special technique that reduces blood flow in the legs can help people with heart failure feel less short of breath and exercise better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Kelowna, British Columbia) |
| Trial ID | NCT05582044 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of lower-body negative pressure (LBNP) on exercise tolerance in patients with heart failure with preserved ejection fraction (HFpEF). The approach aims to reduce venous return during exercise, which may alleviate symptoms of dyspnea and improve overall exercise capacity. Participants will undergo exercise sessions with varying levels of negative pressure applied to the lower body to assess safety and feasibility. The study includes both patients diagnosed with HFpEF and healthy controls for comparison.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with HFpEF who are experiencing mild to moderate symptoms and are clinically stable.
Not a fit: Patients with severe heart failure symptoms or those who are not ambulatory may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve exercise tolerance and quality of life for patients with heart failure.
How similar studies have performed: While the concept of using lower-body negative pressure is novel, similar studies have shown promise in understanding venous return dynamics in heart failure.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kelowna, British Columbia
- University of British Columbia — Kelowna, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Neil D Eves, PhD — The University of British Columbia
- Study coordinator: Stephen P Wright, PhD
- Email: stephen.wright@ubc.ca
- Phone: (250) 807-8860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.