💬In plain words
What the trial is, and whether it could suit you
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 regularl
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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