Heart Failure With Reduced Ejection Fraction
Conditions
Brief summary
The purpose of this study is to compare the impact of inspiratory muscle training (IMT) combined with cardiac rehabilitation (CR) on cardiovascular function in patients with heart failure.
Interventions
DEVICEPowerbreathe
The breathing training will consist of using the PowerBreathe for 12 weeks. The PowerBreathe is an inspiratory pressure threshold trainer. The valve blocks the airflow until the threshold pressure is achieved by breathing in forcefully into the device.
Sponsors
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
HFrEF Patients: (≥18 yrs) receiving guideline directed pharmacologic medical therapy for \>6 weeks (those with contraindications to medical therapy will meet inclusion criteria), NYHA symptoms I-III, no hospitalizations in the \>3 months, have a body mass index ≤45 kg/m2, currently be non-smokers with \<30 pack year history and be able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise).
Exclusion criteria
1. sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1; 2. second or third degree heart block; 3. body mass index \>45 kg/m2; 4. current smokers and/or smoking history \>30 pack years; 5. pregnant women (testing will be done by research team if requested); 6. glomerular filtration rate of \<30 mL/min/1.73m2 (initial screen via clinical record within the past 6 months and this will be assessed on Visit 1); 7. individuals who are not able to engage in exercise; 8. symptomatic peripheral artery disease; 9. asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea; 10. ruptured eardrum or any other condition of the ear; 11. history of spontaneous pneumothorax or osteoporosis with a history of rib fractures; 12. history of lung disease. For individuals agreeing to undergo dual energy x-ray absorptiometry (DEXA) scanning for measurement of body composition as part of their study visit, additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in locomotor muscle blood flow during exercise | Baseline, 12 weeks | Locomotor muscle blood flows will be measured via Doppler-ultrasound. This will be measured in mL/min. |
| Change in respiratory muscle cost of breathing (VO2) | Baseline, 12 weeks | Respiratory muscle cost of breathing is the oxygen uptake (VO2) to the respiratory muscles. Respiratory muscle VO2 is expressed as milliliters of oxygen per kilogram of body mass per minute. |
Countries
United States
Contacts
CONTACTEric Bruhn, M.A
PRINCIPAL_INVESTIGATORJoshua Smith, Ph.D.
Mayo Clinic
Outcome results
None listed