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

Launched by UNIVERSITY OF BRITISH COLUMBIA · Oct 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people with a specific type of heart failure, known as heart failure with preserved ejection fraction (HFpEF). This condition makes it hard for the heart to fill with blood, which can lead to breathlessness, especially during exercise. The researchers want to see if a special cycling device that applies gentle suction to the lower body can help these patients exercise more comfortably and for longer periods. By making it easier to exercise, the goal is to improve their overall health and better understand the causes of their breathlessness.

To participate in the trial, individuals must be adults diagnosed with HFpEF and experiencing mild to moderate symptoms. They should be stable and on consistent heart medication for at least two months. Participants will be asked to attend five visits, during which they will perform exercise tests while wearing the cycling device. Throughout the tests, their exercise duration and breathlessness levels will be recorded, along with measurements of their breathing and heart function. This study not only aims to help those with heart failure but also hopes to pave the way for new treatments in the future.

Gender

ALL

Eligibility 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